Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer

This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and/or effective in treating patients with metastatic colorectal cancer.

开始日期2026-01-23

申办/合作机构

National Cancer Institute

NCT06317662

/ Recruiting临床2期IIT

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

开始日期2026-01-20

申办/合作机构

National Cancer Institute

NCT05296005

/ Withdrawn临床1期IIT

Total Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction (GEJ) and Gastric Cancers: A Pilot Trial

This phase I trial tests the safety, side effects studies chemotherapy followed by chemotherapy at the same time as radiation therapy (chemoradiation) before surgery (neoadjuvant) in treating patients with stage gastric (stomach) or gastroesophageal junction cancer . Chemotherapy drugs, such as docetaxel, oxaliplatin , leucovorin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy and chemoradiation before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

开始日期2025-12-31

申办/合作机构

Ohio State University Comprehensive Cancer Center

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100 项与亚叶酸钙相关的转化医学

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100 项与亚叶酸钙相关的专利（医药）

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12,545

项与亚叶酸钙相关的文献（医药）

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

New recommendations for reversal of high-dose methotrexate cytotoxicity with folinic acid

Review

作者: Heldrup, Jesper ; Guscott, Martin ; Chatelut, Etienne ; Ten, Carolina ; Schwartz, Stefan ; Bleyer, Archie ; Howard, Scott ; Ramsey, Laura ; Hwang, Miriam ; Bernhardt, Brooke ; Schaff, Lauren

PURPOSE:

Folinic acid (FA) rescue protocols to counter the adverse effects of high-dose methotrexate (HDMTX) vary widely, and the risk of over-rescue and potential adverse effects of excessive FA (e.g., hypercalcemia) are under-recognized issues when providing augmented rescue in cases of delayed methotrexate elimination (DME). This opinion summary defines over-rescue, describes its potential adverse impacts, highlights the risk of hypercalcemia associated with excessive FA dosing in patients with acute kidney injury (AKI) from HDMTX, and provides recommendations to improve safety and efficacy of FA rescue in patients receiving HDMTX.

METHODS:

A multidisciplinary panel of experts with clinical experience in HDMTX treatment convened in three roundtable meetings to coalesce expert opinion and best published evidence on the pharmacology and clinical effects and interactions of FA and HDMTX.

RESULTS:

The type of FA (calcium folinate, calcium levofolinate, sodium levofolinate), dose, and frequency of FA administration may be factors for over-rescue and the development of hypercalcemia due to their respective pharmacokinetic characteristics, especially in cases of DME requiring augmented FA rescue.

CONCLUSION:

Clinicians are reminded of the possibility of over-rescue with FA and its impact on subsequent HDMTX courses, types of FA available and their durations of action, and avoid providing too frequent doses. In the setting of AKI and DME requiring high doses of FA, use of sodium levofolinate or calcium levofolinate may be considered to reduce the risk of hypercalcemia associated with calcium folinate.

2025-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous quantification of methotrexate, 7-hydroxymethotrexate and creatinine in serum by LC-MS/MS for predicting delayed elimination

Article

作者: Feng, Yingying ; Xia, Wei ; Ji, Zhengchao ; Sun, Chang ; Pei, Yumei ; Cao, Haiwei ; Li, Yanyan ; Huang, Jing ; Li, Chunzi

High-dose methotrexate (HDMTX) is widely accepted as the first-line chemotherapeutic agent for pediatric acute lymphoblastic leukemia (ALL). However, it exhibits significant pharmacokinetic variability among individuals, which may lead to delayed elimination of MTX. In this study, we innovatively developed a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous quantification of serum MTX, 7-hydroxymethotrexate (7-OHMTX) and creatinine. The analytes were isolated using a protein precipitation method and separated on an Agilent Poroshell 120 SB-C₁₈ column (4.6 × 50 mm, 2.7 µm) using a gradient elution with methanol (B) and 0.1 % formic acid in water (A), at a flow rate of 0.5 mL/min. The assay was linear over the range of 20-2000 ng/mL (R² ≥ 0.997) for MTX and 7-OHMTX and 1-70 μg/mL (R² ≥ 0.997) for creatinine. Intra- and inter-day accuracy for all analytes ranged from 88.1 % to 109.8 % with corresponding precision of 1.0-14.5 %. No significant matrix effects were observed, and analyses were extracted from human serum with recoveries exceeding 93.4 %. The predictive performance of the MTX_48 h, 7-OHMTX_48 h, the 7-OHMTX/MTX_48 h ratio, creatinine_48 h and the combined test value of the four indicators was evaluated using area under the curve (AUC). Receiver operating characteristic (ROC) analysis revealed that MTX_48 h exhibited superior predictive accuracy with sensitivity of 87.5 %, specificity of 93.1 % and AUC of 0.914 compared to 7-OHMTX_48 h with a sensitivity of 50.0 %, specificity of 89.7 % and AUC of 0.683. This finding suggesting that MTX_48 h is a better predictor of delayed elimination than 7-OHMTX_48 h. The 7-OHMTX/MTX_48 h ratio provide a more reliable prediction of delayed elimination compared to 7-OHMTX_48 h alone, emphasizing the importance of metabolic rates in addition to concentration levels. The combined test values of these four indicators at 48 h demonstrated higher predictive accuracy with sensitivity of 93.8 %, specificity of 96.6 % and AUC of 0.963 than any individual index with sensitivity (ranging from 50.0 % to 87.5 %), specificity (ranging from 79.3 % to 93.1 %) and AUC (ranging from 0.683 to 0.914). Notably, this combined test identified delayed elimination at 48 h rather than 72 h, thus enabling timely adjustments to calcium folinate rescue regimens.

2025-08-01·APPLIED RADIATION AND ISOTOPES

MRI radiomics combined with delta-radiomics model for predicting pathological complete response in locally advanced rectal cancer patients after neoadjuvant chemoradiotherapy: A multi-institutional study

Article

作者: Jia, Zhiqiang ; Zeng, Hai ; Wu, Yuanquan ; Ma, Ailin ; Ruzeaiti, Busare ; Tian, Xuwei ; Liang, Guohua

PURPOSE:

To construct and validate a magnetic resonance imaging (MRI) radiomics combined with delta-radiomics and clinical information (C) model for predicting pathological complete response (pCR) in patients with locally advanced rectal cancer (LARC) after neoadjuvant chemoradiotherapy (nCRT).

METHODS:

A total of 198 patients with LARC who underwent MRI before and after nCRT were retrospectively enrolled in this multi-institutional retrospective study. MRI radiomics features were extracted from pre- and post-nCRT diffusion weighted imaging (DWI) and T2-weighted imaging (T2WI) images. The least absolute shrinkage and selection operator (LASSO) and principal component analysis (PCA) algorithm were used to select the optimal predictive features. We constructed the following models, four single-modal radiomics models: DWI-post, DWI-pre, T2-post, T2-pre, two delta-radiomics models: DWI-delta, T2-delta and four multi-modal fusion models: DWI-post + DWI-pre, DWI-post + DWI-delta, DWI-post + DWI-delta + T2-delta, DWI-post + DWI-delta + T2-delta + C. The models were developed using four machine learning classifiers, including Decision Tree (DT), random forest (RF), support vector machine (SVM), and extreme gradient boosting (XGBoost).

RESULTS:

The multi-modal fusion model DWI-post + DWI-delta + T2-delta achieved the best performance with an area under the curve (AUC) of 0.879 for predicting pCR, which was significantly higher than that of the single-modal model DWI-post (optimal AUC = 0.824), DWI-pre (optimal AUC = 0.836) and the delta-radiomics model DWI-delta (optimal AUC = 0.841), T2-delta (optimal AUC = 0.837) in the internal validation sets. XGBoost classifier showed better prediction performance than the other classifiers in the most models. The DWI-post + DWI-pre model with DT classifier and PCA feature selection achieved the highest AUC of 0.754 and the DWI-post + DWI-delta + T2-delta + C model with SVM classifier and LASSO feature selection achieved the suboptimal AUC of 0.734 in the external validation sets.

CONCLUSION:

The multi-modal fusion model significantly outperforms conventional single-modal prediction models. The model could be used as a reliable and noninvasive tool for the personalized therapy in LARC patients.

178

项与亚叶酸钙相关的新闻（医药）

2025-05-31

·PipelineReview

Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations

Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations RAHWAY, NJ, USA I May 30, 2025 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today safety and efficacy results from the open-label Phase 1 KANDLELIT-001 study, a clinical trial evaluating MK-1084, an investigational next-generation KRAS G12C inhibitor, alone and in combination with other therapies in certain patients with KRAS G12C-mutant solid tumors, including advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). In patients with advanced KRAS G12C-mutated CRC and NSCLC, a manageable safety profile and antitumor activity were observed with MK-1084 either as a monotherapy or in the combinations. “We are encouraged by the promising early data from the KANDLELIT-001 study and look forward to further researching the potential for MK-1084, as monotherapy or in combinations, including with KEYTRUDA in certain settings in patients with KRAS mutations, which are among the most prevalent mutations in cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We are committed to evaluating the potential for innovative approaches to help even more patients with cancer and these results further demonstrate the potential of our robust and differentiated pipeline.” In CRC, the study assessed MK-1084 as monotherapy, as well as in combination with cetuximab with or without chemotherapy (oxaliplatin and leucovorin plus 5-fluorouracil [mFOLFOX6]). For efficacy, the study evaluated overall response rate (ORR), with the following results for efficacy evaluable patients: In NSCLC, MK-1084 was evaluated as monotherapy, as well as in combination with KEYTRUDA with or without chemotherapy (carboplatin and pemetrexed), with the following ORR results for efficacy evaluable patients: Across all arms of the KANDLELIT-001 study, MK-1084 had a manageable safety profile. Treatment-related adverse events (TRAEs) occurred in 58% (n=71) of patients in the MK-1084 monotherapy arm, 94% (n=68) of patients in the MK-1084 and KEYTRUDA arm, 93% (n=39) of patients in the MK-1084 in combination with KEYTRUDA and chemotherapy arm, 95% (n=39) of patients in the MK-1084 and cetuximab arm and 97% (n=32) of patients in the MK-1084 with cetuximab and mFOLFOX6 arm. These KANDLELIT-001 CRC and NSCLC data are being presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #3508 and #8605, respectively). In addition to KANDLELIT-001, MK-1084 will be investigated in the Phase 3 KANDLELIT-012 study, which is investigating MK-1084 in combination with cetuximab and mFOLFOX6 for the first-line treatment of certain patients with locally advanced unresectable or metastatic CRC who have KRAS G12C-mutated tumors and the Phase 3 KANDLELIT-004 study, which is investigating MK-1084 in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic NSCLC who have KRAS G12C-mutated tumors and express PD-L1 (TPS ≥50%). MK-1084 is being developed under a collaboration and license agreement with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. About KANDLELIT-001 KANDLELIT-001 is a Phase 1, open-label multicenter clinical trial (Clinical Trials.gov, NCT05067283 ) designed to assess safety, tolerability, pharmacokinetics and efficacy of MK-1084 as monotherapy and in combination with other therapies in patients with KRAS G12C mutated advanced solid tumors. The primary endpoints of the trial were safety and tolerability, as assessed by number of patients who experienced a dose-limiting toxicity, adverse events and treatment discontinuations. Secondary endpoints include objective response rate (ORR) and duration of response. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/ . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . SOURCE: Merck

临床结果临床1期ASCO会议引进/卖出临床3期

2025-05-31

·PipelineReview

Pfizer’s BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer

NEW YORK, NY, USA I May 30, 2025 I Pfizer Inc. (NYSE: PFE) today announced statistically significant and clinically meaningful survival results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. These data will be presented today in an oral presentation (Abstract LBA3500) at the 2025 American Society of Clinical Oncology (ASCO ® ) Annual Meeting and have been simultaneously published in the New England Journal of Medicine . In a second interim analysis of overall survival (OS), a key secondary endpoint, the BRAFTOVI combination regimen reduced the risk of death by 51% compared to standard-of-care chemotherapy with or without bevacizumab (Hazard Ratio [HR] 0.49; 95% Confidence Interval [CI], 0.38, 0.63, p<0.0001). Median OS was 30.3 months (95% CI, 21.7, Not Estimated) with BRAFTOVIin combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without bevacizumab (95% CI, 13.7, 17.7). In the primary analysis of progression-free survival (PFS), the BRAFTOVI combination regimen reduced the risk of disease progression or death by 47% compared to standard-of-care chemotherapy with or without bevacizumab (HR 0.53; 95% CI, 0.41, 0.68, p<0.0001) as assessed by blinded independent central review (BICR). Median PFS was 12.8 months (95% CI, 11.2, 15.9) with the BRAFTOVI combination regimen compared to 7.1 months (95% CI, 6.8, 8.5). “Patients with metastatic colorectal cancer whose tumors harbor a BRAF V600E mutation generally face a daunting prognosis, as this aggressive tumor often does not respond well to standard-of-care chemotherapy,” said Elena Élez, M.D., Ph.D., senior investigator at Vall d’Hebron Institute of Oncology in Barcelona, Spain, and co-principal investigator of the BREAKWATER trial. “The BREAKWATER results are the first promising survival outcomes ever reported for BRAF -mutant metastatic colorectal cancer in the first-line setting, representing a practice-changing breakthrough for patients.” CRC is the third most common type of cancer in the world 1 BRAF mutations are estimated to occur in 8-12% of people with mCRC and represent a poor prognosis. 2 The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in patients with CRC harboring this mutation is more than double that of patients with no known BRAF mutation present. 2-4 “The BRAFTOVI combination helped significantly reduce the risk of disease progression or death, potentially altering the course of disease for people with metastatic colorectal cancer with a BRAF V600E mutation,” said Johanna Bendell, M.D., Chief Oncology Development Officer, Pfizer. “These unprecedented results from the BREAKWATER trial further establish the benefit of the BRAFTOVI combination regimen and its potential to become a new standard-of-care, building on Pfizer’s legacy in precision medicine and commitment to delivering breakthrough medicines that help people with cancer live better and longer lives.” The updated objective response rate (ORR) by BICR confirmed the improvement previously observed with the BRAFTOVI combination regimen compared to patients receiving chemotherapy with or without bevacizumab (65.7%; 95% CI, 59.4, 71.4 and 37.4%; 95% CI, 31.6, 43.7, respectively). The estimated median duration of response and median time to response were also maintained from the prior primary analysis. Results from the primary analysis of ORR were presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI) and were simultaneously published in Nature Medicine in January 2025. Additional data from a separate arm of the BREAKWATER study evaluating BRAFTOVI in combination with cetuximab will also be presented at ASCO. “The risk of death for patients with BRAF V600E -mutant metastatic colorectal cancer is more than double compared to those with no known mutation,” said Michael Sapienza, Chief Executive Officer, Colorectal Cancer Alliance. “These survival outcomes from the BREAKWATER study bring renewed hope to patients and their loved ones, providing the possibility of more time together. We are thrilled to see important cancer research propel us closer to our goal of ending this disease.” At the time of this analysis, the safety profile of BRAFTOVI in combination with cetuximab and mFOLFOX6 continued to be consistent with the known safety profile of each respective agent. No new safety signals were identified. The most common side effects (≥30%) were nausea, anemia, diarrhea, decreased appetite, vomiting, neutrophil count decrease, arthralgia, and rash. Among patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6, 13.8% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI. The BRAFTOVI combination regimen received accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2024 for patients with BRAF V600E -mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed ORR in treatment-naïve patients, the study’s other dual primary endpoint. 5 Continued approval for this indication is contingent upon verification of clinical benefit. The approval was among the first in the industry to be conducted under the FDA’s Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease. The BREAKWATER survival data are being discussed with the U.S. FDA to support potential conversion to full approval in 2025. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries. About BREAKWATER BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with mFOLFOX6 in participants with previously untreated BRAF V600E -mutant metastatic CRC. Patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once daily in combination with cetuximab and mFOLFOX6 (n=236) or mFOLFOX6, FOLFOXIRI, or CAPOX each with or without bevacizumab (control-arm) (n=243). The dual primary endpoints are ORR and progression-free survival (PFS) as assessed by blinded independent central review (BICR). Overall survival is a key secondary endpoint. About Colorectal Cancer (CRC) CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022. 1 It is the second leading cause of cancer-related deaths. 6 Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women. 6 In the U.S. alone, an estimated 154,270 people will be diagnosed with cancer of the colon or rectum in 2025, and approximately 53,000 are estimated to die from the disease each year. 7 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat, and up to 50% of patients with localized disease eventually develop metastases. 8 BRAF mutations are estimated to occur in 8-12% of people with mCRC and represent a poor prognosis for these patients. 2 The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in patients with CRC with the BRAF V600E mutation is more than double that of patients with no known BRAF mutation present. 2-4 Despite the high unmet need in BRAF V600E -mutant mCRC, prior to December 20, 2024, there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E -mutant mCRC. 9,10 About BRAFTOVI ® (encorafenib) BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E . Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC. Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre Laboratories has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea). INDICATION AND USAGE BRAFTOVI ® (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BRAFTOVI is also indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC. View the full Prescribing Information . About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer . References SOURCE: Pfizer

临床结果ASCO会议临床3期加速审批引进/卖出

2025-05-30

·药明康德

一半患者肿瘤消失！默沙东ADC联合疗法积极数据公布；持续2年无复发！罗氏穿越血脑屏障小分子亮眼数据公布……

一半患者肿瘤消失！默沙东ADC联合疗法积极数据公布默沙东（MSD）今日公布了2/3期waveLINE-003研究的积极结果，该研究评估其在研抗体偶联药物（ADC）zilovertamab vedotin联合标准治疗利妥昔单抗和吉西他滨-奥沙利铂（R-GemOx）治疗复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）的效果。在预设分析中，1.75 mg/kg剂量的zilovertamab vedotin联合R-GemOx在复发或难治性DLBCL患者（n=16）中实现了56.3%的客观缓解率（ORR），包括8例完全缓解（CR）和1例部分缓解（PR）。Zilovertamab vedotin是一种靶向受体酪氨酸激酶样孤儿受体1（ROR1）的潜在“first-in-class”抗体偶联药物。ROR1是一种在多种血液系统恶性肿瘤中过度表达的跨膜蛋白。该疗法目前正在3期waveLINE-010研究和2期waveLINE-007研究中评估用于初治DLBCL患者。此外，2期waveLINE-011研究也在近期启动，旨在评估该疗法联合利妥昔单抗和环磷酰胺、多柔比星及泼尼松（R-CHP）对比获批ADC疗法polatuzumab vedotin联合R-CHP治疗DLBCL患者的效果。首次！辉瑞小分子联合疗法有望获得完全批准辉瑞（Pfizer）今日公布了关键3期BREAKWATER试验中Braftovi（encorafenib）联合西妥昔单抗和mFOLFOX6（氟尿嘧啶、亚叶酸钙和奥沙利铂）治疗BRAF V600E突变转移性结直肠癌（mCRC）患者的统计学显著且具有临床意义的积极生存结果。与标准治疗相比，接受Braftovi联合疗法治疗患者的死亡风险降低51%。详细数据将在2025年美国临床肿瘤学会（ASCO）年会上以口头报告形式公布，并同步发表于《新英格兰医学杂志》。辉瑞将与美国FDA分享这些最新结果，以潜在支持Braftovi联合疗法治疗BRAF V600E突变mCRC患者的完全批准。新闻稿指出，Braftovi联合疗法是可改善初治BRAF V600E突变转移性结直肠癌患者生存结局的首个靶向联合疗法。在关键次要终点总生存期（OS）的第二次中期分析中，Braftovi联合方案与含或不含贝伐珠单抗的标准化疗相比，死亡风险降低51%（HR=0.49；95% CI：0.38-0.63，p<0.0001)。Braftovi联合西妥昔单抗和mFOLFOX6组的中位OS为30.3个月（95% CI：21.7-不可评估)，而活性对照组为15.1个月（95% CI：13.7-17.7）。在双主要终点之一无进展生存期（PFS）的分析中，经盲法独立中心评审（BICR）评估，Braftovi联合方案与活性对照药物相比，疾病进展或死亡风险降低47%（HR=0.53；95% CI：0.41-0.68，p<0.0001)。Braftovi联合方案组的中位PFS为12.8个月（95% CI：11.2-15.9)，而对照组为7.1个月（95% CI：6.8-8.5）。Braftovi是一款靶向BRAF V600E的口服小分子激酶抑制剂。Braftovi联合疗法于2024年12月获得美国FDA的加速批准，用于治疗携带BRAF V600E突变的初治mCRC患者。默沙东下一代KRAS小分子抑制剂积极抗癌结果公布默沙东今日公布了KANDLELIT-001研究的积极安全性和疗效结果。研究显示，在晚期KRAS G12C突变型结直肠癌（CRC）和非小细胞肺癌（NSCLC）患者中，其在研下一代KRAS G12C抑制剂MK-1084无论作为单药治疗还是联合治疗，均展现出可控的安全性特征和抗肿瘤活性。KANDLELIT-001是一项开放标签的1期临床试验，旨在评估在携带KRAS G12C突变的实体瘤患者中，MK-1084作为单药以及与其他疗法联合治疗的效果。在CRC队列中，研究评估了MK-1084的单药疗法，以及其与西妥昔单抗联合治疗，联合方案中可含或不含化疗（奥沙利铂和亚叶酸钙联合5-氟尿嘧啶，即mFOLFOX6）。疗效方面，研究评估了ORR，以下为可评估疗效患者的结果：▲KANDLELIT-001试验中，CRC队列疗效结果（图片来源：参考资料[3]）在NSCLC队列中，MK-1084被用于单药治疗，也被用于与Keytruda联合治疗，联合方案中可含或不含化疗（卡铂和培美曲塞），以下为可评估疗效患者的ORR结果：▲KANDLELIT-001试验中，NSCLC队列疗效结果（图片来源：参考资料[3]）在KANDLELIT-001研究的所有治疗队列中，MK-1084均表现出可控的安全性特征。患者持续2年无复发！罗氏穿越血脑屏障小分子亮眼数据公布日前，罗氏（Roche）与旗下基因泰克（Genentech）公布其口服布鲁顿酪氨酸激酶（BTK）抑制剂fenebrutinib在复发型多发性硬化（RMS）患者中96周的最新研究数据。分析显示，患者在使用该药治疗近两年后的复发率低，脑部无活动性病灶，且功能障碍无进展。Fenebrutinib用于复发型和原发进展型多发性硬化的3期研究预计将在年底公布结果。共有99位患者进入开放标签延长期（OLE）试验，至第96周时仍有93位患者继续参与试验。分析显示，在OLE期间，接受长达96周fenebrutinib治疗患者的年化复发率（ARR）为0.06，且在此期间未见残疾进展（基于扩展残疾状态评分量表EDSS评估）。此外，磁共振成像（MRI）结果显示，fenebrutinib可抑制脑内疾病活动。至96周时，未检测到活动性炎症标志物新发T1钆增强（T1-Gd+）病灶。在OLE阶段中，从安慰剂转为fenebrutinib治疗的患者，其新发或增大的T2病灶年化发生率从双盲期12周末的6.72下降至96周时的0.34，表明慢性病灶负担明显减轻。Fenebrutinib是一种口服、可逆且非共价的BTK抑制剂，能够阻断BTK的功能。BTK是一种调控B细胞发育和活化的酶，同时也参与调控免疫系统中髓样细胞，如巨噬细胞和小胶质细胞的激活。临床前数据显示，fenebrutinib具有高效力和高选择性。Fenebrutinib显示出对BTK的选择性是对其他激酶的130倍，其高选择性和可逆性的特性可能降低分子的脱靶效应，从而有助于药品的长期安全性。参考资料：[1] Merck’s Investigational Zilovertamab Vedotin at 1.75 mg/kg Dose Plus Standard of Care Showed Promising Antitumor Activity, Including Complete Response Rate, in Patients With Relapsed/Refractory DLBCL in Phase 2 Portion of waveLINE-003 Trial. Retrieved May 30, 2025 from https://www.merck.com/news/mercks-investigational-zilovertamab-vedotin-at-1-75-mg-kg-dose-plus-standard-of-care-showed-promising-antitumor-activity-including-complete-response-rate-in-patients-with-relapsed-refractor/[2] Pfizer’s BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer. Retrieved May 30, 2025 from https://www.businesswire.com/news/home/20250530872619/en/Pfizers-BRAFTOVI-Combination-Regimen-Cuts-the-Risk-of-Death-in-Half-for-Patients-with-BRAF-V600E-Mutant-Metastatic-Colorectal-Cancer[3] Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations. Retrieved May 30, 2025 from https://www.merck.com/news/merck-announces-mk-1084-an-investigational-kras-g12c-inhibitor-shows-antitumor-activity-in-phase-1-trial-of-patients-with-advanced-colorectal-cancer-and-non-small-cell-lung-cancer-whose-tumors-harbo/[4] Roche’s fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis. Retrieved May 30, 2025 from https://www.roche.com/media/releases/med-cor-2025-05-30免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。👇 分享，点赞，在看，聚焦全球生物医药健康创新

临床结果ASCO会议抗体药物偶联物临床3期临床2期

100 项与亚叶酸钙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01211	亚叶酸钙	V03AF03	DB00650

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
结直肠癌	日本	Taiho Pharmaceutical Co., Ltd.	2003-07-17
结直肠癌	日本	Pfizer Japan, Inc.	2003-07-17
药物中毒	日本	Pfizer Japan, Inc.	1963-01-11
贫血	美国	Hospira, Inc.	1952-06-20

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
III期结肠癌	临床3期	奥地利	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	比利时	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	埃及	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	法国	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	德国	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	意大利	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	葡萄牙	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	西班牙	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	瑞士	Pfizer Inc.	2001-01-01
III期结肠癌	临床3期	英国	Pfizer Inc.	2001-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03861702 (BTCRC-GI15-067, CTgov)	临床2期	局部晚期胰腺腺癌	28	LEUCOVORIN CALCIUM+Liposomal Irinotecan+Oxaliplatin+Fluorouracil	鬱遞鬱遞淵構製繭獵糧 = 構夢糧艱壓窪選艱衊築鬱壓廠願願鏇憲獵齋襯 (鏇壓鬱願淵獵糧蓋衊構, 壓簾衊蓋餘廠膚壓憲積 ~ 顧蓋鹹獵願選簾網鏇築) 更多	-	2025-04-18
NCT04380337 (SHORT-FOX, CTgov)	临床2期	直肠癌 \| 直肠腺癌	38	IMRT+LEUCOVORIN CALCIUM+irinotecan+oxaliplatin+capecitabine+Fluorouracil	築選築選鏇鹹襯築鏇淵 = 壓襯廠製網鬱夢鏇廠憲淵膚遞衊艱選願製廠蓋 (鬱鑰簾觸範構範鹽窪夢, 蓋憲窪衊網願襯齋糧憲 ~ 餘餘網製繭襯廠簾網積) 更多	-	2025-02-25
JPRN-jRCTs031200094 (ASCO_GI2025)	临床2期	食管鳞状细胞癌新辅助	54	Neoadjuvant FLOT therapy	糧膚繭鹽淵願夢壓範鏇(製積淵夢夢鏇膚衊壓齋) = 遞衊積製積遞廠襯獵簾衊鬱壓壓醖艱構齋網蓋 (鬱蓋壓繭網餘網憲鹹鏇, 29.8 ~ 57.7) 更多	积极	2025-01-23
NCT04233866 (EA2186 (GIANT), ASCO_GI2025)	临床2期	转移性胰腺癌	176	Arm A: Gemcitabine + Nab-Paclitaxel	憲範鹽顧膚選淵鏇蓋選(選窪糧選觸窪鏇鹹鹹齋) = 膚襯簾膚獵鏇顧積構顧蓋醖醖廠獵餘壓積簾鑰 (鬱醖顧築觸鹹願窪製築 ) 更多	积极	2025-01-23
				Arm B: 5-Fluorouracil + Leucovorin + Liposomal Irinotecan	憲範鹽顧膚選淵鏇蓋選(選窪糧選觸窪鏇鹹鹹齋) = 憲淵願夢遞醖鏇遞醖築蓋醖醖廠獵餘壓積簾鑰 (鬱醖顧築觸鹹願窪製築 ) 更多
NCT03885284 (Proton-PANC, CTgov)	临床1期	胰腺腺癌	9	mFOLFIRINOX (Dose Level 1)	鏇築襯範鏇製鹽壓顧積 = 選遞糧築齋蓋鹹壓簾觸壓夢獵齋遞鑰構糧餘網 (醖遞範齋鬱壓繭築糧積, 鑰襯鬱鬱壓艱齋鹹鏇窪 ~ 鹹鬱鑰願構膚糧膚憲遞) 更多	-	2024-10-24
				mFOLFIRINOX (Dose Level 2)	鏇築襯範鏇製鹽壓顧積 = 襯鏇簾願構遞壓艱鬱獵壓夢獵齋遞鑰構糧餘網 (醖遞範齋鬱壓繭築糧積, 遞艱艱鏇顧膚糧觸簾鹹 ~ 衊簾鹹鹽蓋衊壓鏇顧鹹) 更多
NCT03483038 (NEO-Nal-IRI, CTgov)	临床2期	胰腺腺癌	45	LEUCOVORIN CALCIUM+Liposomal Irinotecan+Oxaliplatin+Fluorouracil	簾顧壓壓遞廠範窪膚衊 = 醖鏇鹽憲範餘壓遞積鏇積遞夢選簾夢艱繭網壓 (鏇願淵範壓選製鏇壓構, 願艱膚築壓範夢窪製鑰 ~ 壓觸壓鏇願製範鏇鹽餘) 更多	-	2024-09-23
NCT05026905 (TCOG T5221, ESMO2024) 人工标引	临床2期	胰腺癌一线	50	GASL (Gemcitabine plus nab-paclitaxel and S-1/leucovorin	築襯積築艱製憲製構鑰(鹹觸淵鬱製築糧鹹鹽廠) = 鏇醖選獵夢製夢廠獵膚鑰餘鑰繭醖願構淵構壓 (築築淵憲壓廠鏇繭壓鏇 ) 更多	积极	2024-09-16
				GAP (Gemcitabine plus nab-paclitaxel and oxaliplatin)	築襯積築艱製憲製構鑰(鹹觸淵鬱製築糧鹹鹽廠) = 觸鏇壓遞選構鏇窪憲膚鑰餘鑰繭醖願構淵構壓 (築築淵憲壓廠鏇繭壓鏇 ) 更多
NCT01595321 (CTgov)	临床2期	胰腺腺癌	19	Stereotactic Body Radiation+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (Cohort 1: SBRT and FOLFIRINOX)	遞鑰選鹹遞餘積醖窪鬱 = 簾醖淵網糧糧襯鏇遞糧淵膚選鏇獵構齋築簾襯 (鹽壓廠醖膚鏇簾繭繭網, 網觸簾觸觸齋醖壓構襯 ~ 壓艱範積醖壓廠鹽積壓) 更多	-	2024-08-14
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	遞鑰選鹹遞餘積醖窪鬱 = 餘蓋夢簾簾艱觸鏇醖鏇淵膚選鏇獵構齋築簾襯 (鹽壓廠醖膚鏇簾繭繭網, 餘衊網簾顧鹹簾觸艱襯 ~ 糧糧餘糧窪範夢餘顧廠) 更多
NCT02352337 (PRODIGE 35-PANOPTIMOX \| PANOPTIMOX, CTgov)	临床2期	转移性胰腺癌	276	Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX)	鹽觸鹹窪願積鹽艱醖簾 = 衊網鬱獵衊願襯構簾夢膚顧製簾夢顧繭襯艱製 (鑰膚觸簾鬱餘簾鹹簾遞, 鏇鏇鏇構觸廠憲齋構範 ~ 壓網積鬱醖獵糧鹹窪齋) 更多	-	2024-07-10
				LV+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX + LV5FU2 in Maintenance)	鹽觸鹹窪願積鹽艱醖簾 = 夢膚餘憲夢鬱築選艱鹹膚顧製簾夢顧繭襯艱製 (鑰膚觸簾鬱餘簾鹹簾遞, 鏇繭醖遞獵糧夢網壓簾 ~ 廠觸憲廠繭構壓願顧遞) 更多
NCT02384759 (FOLFA, CTgov)	临床2期	结直肠癌	117	LV5FU2+Aflibercept (Aflibercept + LV5FU2)	積淵夢繭蓋簾願餘廠膚(顧範廠膚鬱餘餘簾齋糧) = 簾範願遞憲範餘窪壓齋繭鹹製鹹簾廠鏇鏇窪簾 (蓋餘觸繭糧憲鹽齋選壓, 鑰夢積蓋繭網簾獵蓋鏇 ~ 廠築醖餘遞網衊淵齋選) 更多	-	2024-07-10
				LV5FU2+folinic acid+5FU (LV5FU2)	積淵夢繭蓋簾願餘廠膚(顧範廠膚鬱餘餘簾齋糧) = 範積選簾淵艱廠願製顧繭鹹製鹹簾廠鏇鏇窪簾 (蓋餘觸繭糧憲鹽齋選壓, 餘遞選鑰廠觸選夢蓋鑰 ~ 構壓積糧繭艱構鏇遞鏇) 更多