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

NCT05375708

/ Suspended临床2期IIT

A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer

A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.

开始日期2025-12-01

申办/合作机构

University Medical Center of Utrecht

NCT06291064

/ Not yet recruiting临床2期IIT

TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).
All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

开始日期2025-11-01

申办/合作机构

The University of Chicago

100 项与卡培他滨相关的临床结果

登录后查看更多信息

100 项与卡培他滨相关的转化医学

登录后查看更多信息

100 项与卡培他滨相关的专利（医药）

登录后查看更多信息

13,421

项与卡培他滨相关的文献（医药）

2025-12-01·Journal of Gastrointestinal Cancer

Development of a Prognostic Nomogram for Overall Survival in Gastric Cancer Patients Who Underwent Adjuvant Chemoradiotherapy

Article

作者: Avci, Hanife ; Ozyurek, Yasin ; Hurmuz, Pervin ; Yilmaz, Melek Tugce ; Yigit, Ecem ; Dag, Osman ; Cengiz, Mustafa

PURPOSE:

The aim of this study was to identify prognostic factors influencing overall survival (OS) in patients with gastric cancer treated with adjuvant chemoradiotherapy (CRT) and to develop a predictive model.

METHODS:

We retrospectively evaluated 245 non-metastatic gastric cancer patients who received adjuvant CRT or radiotherapy from 2010 to 2020. Survival analyses were performed using the Kaplan-Meier method. Prognostic factors were identified through univariate and multivariate Cox regression analyses. A nomogram was constructed based on significant predictive factors for OS, including lymph node ratio, T classification, tumor location, and local recurrence.

RESULTS:

The median follow-up duration was 41.5 months (range, 6-144.8 months). The 2- and 5-year OS and progression-free survival were 77% and 53% and 64% and 49%, respectively. In multivariate analysis, tumor location (distal vs. proximal), pT classification (pT1-2 vs. pT3-4), lymph node ratio (< 0.18 vs. ≥ 0.18), and presence of local recurrence were independent prognostic factors for OS. The optimal cut-off value for the total nomogram score predicting OS was 116 points. Patients with < 116 points had 2- and 5-year OS rates of 87% and 73%, respectively, compared to 67% and 30% for those with ≥ 116 points.

CONCLUSION:

A nomogram was constructed incorporating lymph node ratio, T classification, tumor site, and local recurrence for gastric cancer patients receiving adjuvant CRT. Patients with a total score below 116 demonstrated higher survival rates. This nomogram may aid in defining optimal follow-up intervals.

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Dihydropyrimidine enzyme activity and its effect on chemotherapy toxicity: importance of genetic testing

Article

作者: Villano, John L ; Pandey, Deepali ; Roberts, Danielle ; Williams, Abby ; Shamaei Zadeh, Alexia

PURPOSE:

Patients with partial or complete DPD deficiency have decreased capacity to degrade fluorouracil and are at risk of developing toxicity, which can be even life-threatening.

CASE:

A 43-year-old man with moderately differentiated rectal adenocarcinoma on capecitabine presented to the emergency department with complaints of nausea, vomiting, diarrhea, weakness, and lower abdominal pain for several days. Laboratory findings include grade 4 neutropenia (ANC 10) and thrombocytopenia (platelets 36,000). Capecitabine is used as a component of first-line adjuvant therapy by approximately 2 million patients worldwide each year. Capecitabine is metabolized to fluorouracil via the enzyme dihydropyrimidine dehydrogenase (DPD). With worsening pancytopenia and diarrhea, genetic testing for DPD deficiency was sent. Prompt treatment with uridine triacetate was initiated for presumed DPD deficiency. Unfortunately, he passed away from an infectious complication and was later confirmed to have a heterozygous DPYD*2A mutation.

DISCUSSION:

Our case demonstrates uneven testing guidelines for DPD prior to initiating 5-FU chemotherapy, appropriateness of treating with uridine triacetate, and analysis of next-generation sequencing (NGS) on tumor samples and co-incidentally obtaining germline DPD deficiency status. Our case also highlights the severe clinical impact of having DPD deficiency even with early uridine triacetate therapy.

CONCLUSION:

It is our recommendation to perform DPD deficiency in curative intent cancer treatment and this information can increasingly be obtained in standard tumor NGS profiling, a growing norm in medical oncology.

2025-12-01·Journal of Gastrointestinal Cancer

Impact of Retroperitoneal Lymphadenopathy (RPLN) on the Outcomes of Locally Advanced Gall Bladder Cancer (GBC) Following Chemotherapy (CT) or Chemotherapy Followed by Consolidation Chemoradiotherapy (CTRT)

Article

作者: Naik, Nagendra ; Priyanka, Parul ; Agrawal, Sushma

INTRODUCTION:

Retroperitoneal lymphadenopathy is considered a metastatic disease in GBC; however, some surgical series of radical surgery with enlarged RPLN who underwent RPLN dissection have shown results marginally inferior to those without enlarged RPLN. Radiological RPLN comprises a major proportion of advanced non-metastatic GBC. There is dilemma in the intent of treatment to be offered in such cases. We are reporting our series of outcome of GBC with RPLN treated with first-line CT followed by consolidation CTRT.

MATERIALS AND METHODS:

Non-metastatic locally advanced GBC with good performance status (KPS ≥ 80) were initiated on first-line CT (cisplatin-gemcitabine), and thereafter, responders were evaluated by CECT-angiography and PET-CT scan for resectability. If found unresectable, they were offered consolidation CTRT to a dose of 45 Gy by conventional fractionation (3D-CRT technique) along with concurrent capecitabine at 1250 mg/m² to GBC and regional lymphatics including RPLN. Thereafter, boost dose of 9 Gy/5# was given to GBC only. Response assessment was done using CECT abdomen by RECIST criteria v 1.1. Outcomes (overall survival) of the two groups (RPLN vs non-RPLN) were computed with Kaplan-Meier survival curves and chi-square tests using SPSS v 20.

RESULTS:

Among 189 patients of advanced non-metastatic GBC recruited from 2011 to 2022, 80 had RPLN. The demographic features of both groups were comparable. Overall, 68% of the patients were women, 30% underwent upfront stenting for obstructive jaundice, and 90% had T3 and T4 disease. Only 10% had undergone upfront laparoscopic staging and had pathologically proven RPLN. Forty percent of the patients received four cycles of CT only and 50% of the patients received six cycles or more and 33% received CTRT. By RECIST criteria, 10% vs 16% achieved complete response (CR), 39% vs 41% achieved partial response (PR), 16% vs 15% achieved stable disease (SD), 2.7% vs 6% had disease progression (PD), and 14.5% vs 3.7% were non-evaluable in non-RPLN group vs RPLN group, respectively. 12% vs 6% could undergo radical surgery in non-RPLN group vs RPLN group (p = 0.03). The median OS was 9 months (95% CI 7.6-10.3 months) vs 10 months (95% CI 8-9.8 months) (p = NS) in non-RPLN group vs RPLN group, respectively. In those who received CT only, the median OS was 7 months vs 8 months, while in those who received CT followed by CTRT, the median OS was 14 months vs 13 months (p = 0.65) in non-RPLN group vs RPLN group, respectively.

CONCLUSIONS:

Based on this analysis, we conclude that RPLN constitutes a major proportion of advanced non-metastatic GBC and has outcomes similar to those without RPLN if treated with radical intent. RPLN should not be considered a metastatic disease and should be treated with radical intent.

1,067

项与卡培他滨相关的新闻（医药）

2025-05-31

·ioncology

ASCO浙二之声丨丁克峰教授团队携口头报告亮相2025年ASCO 大会，结直肠癌ANCHOR研究结果引关注

当地时间5月30日，2025 年美国临床肿瘤学会（ASCO）年会在芝加哥拉开帷幕，我院常务副书记丁克峰教授及其团队带来了一项重磅研究成果，并在大会上进行了口头汇报，吸引了众多专家学者的关注，这一成果为 RAS/BRAF 野生型不可切除转移性结直肠癌（mCRC）患者的一线治疗提供了全新的选择和希望。研究背景结直肠癌是全球范围内发病率和死亡率均较高的恶性肿瘤之一，对于RAS/BRAF野生型不可切除的mCRC，目前标准一线治疗方案是贝伐珠单抗或西妥昔单抗联合化疗。口服小分子多靶点酪氨酸激酶抑制剂（TKI）已被证实在mCRC后线治疗有效，且口服治疗能提高患者的治疗便利性。安罗替尼作为一种口服多靶点TKI，具有调控肿瘤血管基质重编程和肿瘤细胞重编程的作用，既往的 II 期临床研究ALTER-C002研究已证实安罗替尼联合CapeOX在晚期不可切除RAS/BRAF野生型结直肠癌患者中具有良好的抗肿瘤活性和可控的安全性。基于此，丁克峰教授团队开展了一项“安罗替尼联合CapeOX对比贝伐珠单抗联合CapeOX一线治疗不可切除、转移性RAS/BRAF野生型结直肠癌的多中心、随机对照III期注册临床研究（ANCHOR研究）”（NCT04854668, CTR20210940），旨在比较安罗替尼联合CapeOX与贝伐珠单抗联合 CapeOX一线治疗RAS/BRAF野生型mCRC患者的疗效和安全性。研究方法该研究是一项随机对照、开放标签、非劣效性 III 期临床试验。主要纳入标准为：年龄18-75周岁，ECOG 体能状态评分为 0 或 1，经组织学或细胞学证实的 RAS/BRAF 野生型结直肠癌，且经多学科团队评估为不可切除的转移性病变，既往未经系统治疗。主要排除标准包括：高度微卫星不稳定或错配修复缺陷状态，可切除或潜在可切除的转移性病变等。符合入组标准的患者按照 1:1 的比例随机分配至安罗替尼组或贝伐珠单抗组。患者将接受 4-8 个周期的诱导治疗（安罗替尼或贝伐珠单抗联合CapeOX），随后进入维持治疗阶段（安罗替尼或贝伐珠单抗联合卡培他滨），直至疾病进展或出现不可接受的毒性反应。研究的主要终点是由独立评审委员会（IRC）评估的无进展生存期（PFS），次要终点包括研究者评估的 PFS、总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DOR）、肝转移灶转化切除率、生活质量以及安全性等。研究结果当地时间5月30日14:45，丁克峰教授在ASCO大会口头汇报了该研究的主要结果，安罗替尼组和贝伐珠单抗组中IRC评估的中位PFS均为11.04个月，HR=1.0（95% CI, 0.84-1.18），两组维持治疗期IRC评估的中位PFS分别为7.06个月和6.90个月，HR=0.99（95% CI, 0.81-1.21）；在 ORR、DCR、DOR、肝转移灶转化切除率等次要终点上，两组未显示出统计学差异；安全性和生活质量数据显示两组安全性可控，未出现新的安全性问题。研究结论丁克峰教授在口头汇报中指出，这项研究具有重要的临床意义。其一，在RAS/BRAF野生型mCRC一线治疗中，安罗替尼联合CapeOX方案与贝伐珠单抗联合CapeOX方案展现出相当的抗肿瘤活性，且安全性可控，患者健康相关生活质量也具有可比性。其二，安罗替尼联合卡培他滨的无静脉维持治疗方案可提高mCRC患者的用药便利性和治疗依从性。研究展望此次丁克峰教授团队在ASCO大会上的精彩汇报，不仅展示了浙大二院在结直肠癌领域的深厚科研实力和临床水平，也为全球结直肠癌治疗领域的发展贡献了中国智慧和力量。丁克峰教授、主任医师、博士生导师浙大二院常务副书记、党委委员国家“四大慢病”科技重大专项首席科学家国家“十三五”重点研发计划首席科学家浙江大学肿瘤学科学位点负责人长期从事肿瘤外科、大肠癌临床一线工作；是全国大肠外科一线手术医生，全国大肠肿瘤多学科诊治体系的主要专家。曾分别赴日本、澳大利亚、英国等多家医院研修工作学习。在肿瘤的早诊早治、肿瘤外科、大肠癌综合治疗，微创手术、肿瘤转移、肿瘤耐药等临床和科研领域取得成绩。主持国家“四大慢病”科技重大专项1项、主持负责国家“十三五”重点研发计划1项、国家自然科学基金课题8项，浙江省重点研发计划1项及浙江省“领雁”研发攻关计划1项，主持临床研究6项，近5年发表SCI 及国内核心期刊论文50余篇。主要社会团体和学会兼职有：中国医师协会结直肠肿瘤专委会外科专委会主任委员中国抗癌协会NOSES专业委员会主任委员中国抗癌协会大肠癌专业委员会副主任委员中华医学会肿瘤分会常务委员浙江省抗癌协会大肠癌专业委员会候任主任委员浙江省医学会理事肿瘤外科分会候任主委精准医疗学会主任委员（来源：浙二大肠癌诊治中心）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床结果临床3期临床2期

2025-05-30

·GlobeNewswire-Health Care

Processa Pharmaceuticals Announces Presentation and Publication of Three Abstracts at 2025 ASCO Annual Meeting

HANOVER, Md., May 30, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation cancer therapies with improved efficacy and safety, today announced the acceptance of three abstracts for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois. The abstracts highlight Processa’s pipeline of Next Generation Cancer (NGC) drug candidates, including PCS6422 (NGC-Cap) and PCS11T (NGC-Iri), showcasing both preclinical and clinical advances. Trials in Progress Poster Presentation and Abstract Publication Abstract Title: Adaptive Designed Eniluracil + Capecitabine Phase 2 Trial in Advanced or Metastatic Breast Cancer PatientsAbstract Number: TPS1133 | Poster Board Number: 105bSession Title: Breast Cancer—MetastaticDate & Time: June 2, 2025 | 9:00 AM–12:00 PM CDTDr. David Young, Founder and President of Research & Development at Processa, will be presenting an overview of Processa’s ongoing Phase 2 adaptive design trial evaluating the safety and efficacy of PCS6422 (eniluracil) combined with capecitabine in patients with advanced or metastatic breast cancer. The study explores optimal dosing regimens and a personalized medicine approach to improve outcomes and tolerability. Abstract Publications 1. Abstract Title: Safety and Efficacy of Eniluracil + Capecitabine (6422 + Cap) in Phase 1b Trial Abstract Number: e15152 This online-only abstract provides data from the Phase 1b study that defined the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for NGC-Cap (eniluracil + capecitabine or 6422 + Cap), highlighting its improved safety profile and anti-tumor activity compared to standard capecitabine. 2. Abstract Title: Preclinical Project Optimus Dose Escalation of SN-38 Pro-Drug PCS11T Abstract Number: e15023 This online-only abstract outlines a Project Optimus-aligned approach to define the optimal therapeutic window of PCS11T, a tumor-targeted pro-drug of SN-38. PCS11T is designed to increase drug concentration in tumors while reducing systemic toxicity. “These ASCO presentations and publications reflect the breadth of our oncology pipeline and the progress we’re making across multiple programs,” said Dr. David Young. “From our Phase 2 clinical program in metastatic breast cancer to preclinical innovations with PCS11T, we are leveraging our Regulatory Science Approach and deep oncology expertise to address critical unmet needs.” About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations:Dave GentryRedChip Companies, Inc.1-407-644-4256PCSA@redchip.com

ASCO会议临床1期临床2期

2025-05-29

·ioncology

EASL面对面丨陆荫英教授解读2025年EASL肝外胆管癌新指南，解码诊疗新规范

编者按日前，2025年欧洲肝病研究学会（EASL）年会在荷兰阿姆斯特丹落下帷幕。会上，《EASL肝外胆管癌管理临床实践指南》正式公布，为肝外胆管癌的诊断、治疗及管理带来了全新的方向与规范。本刊特邀解放军总医院第五医学中心陆荫英教授对这份重磅指南进行深入解读。陆荫英教授从疾病定义与诊断的更新入手，详细阐述了肝外胆管癌的分类细化以及早期筛查的重点人群与策略调整。同时，她还针对指南中遗传咨询的适用性，分享了在平衡患者知情权与焦虑风险方面的经验与思考，并对未来研究方向提出了独到见解。陆荫英教授的解读深入浅出，为医学同仁们拨开了2025年EASL新指南的“神秘面纱”，让大家能迅速把握要点，将其应用到临床实践中，推动肝外胆管癌诊疗水平迈向新台阶。《国际肝病》2025年《EASL 肝外胆管癌管理临床实践指南》公布，能否请您分享本次指南更新内容及其影响？陆荫英教授01简定义与诊断2025年《EASL肝外胆管癌管理临床实践指南》与2024年NCCN指南相比，在分类、早筛、诊断和治疗方面有部分更新。在疾病诊断和分类上，明确肝外胆管癌是源于肝管和胆总管的恶性肿瘤，肝管包括右肝管、左肝管和共同肝管，并再次细化将肝外胆管癌分为肝门部胆管癌和远端胆管癌。“胆道癌”应作为宽泛定义，涵盖所有源自胆道的恶性肿瘤，包括肝内胆管癌、肝外胆管癌以及具有胆道分化的胆囊癌和壶腹癌。02早期筛查在早期筛查方面，EASL新版指南强调对原发性硬化性胆管炎、胆管囊肿、肝吸虫病史患者定期监测，且明确有个人或家族肿瘤史、癌症史以及存在特定遗传改变的胆管癌高发基因人群应进行遗传咨询，而非盲目进行遗传咨询与检测。03诊断检查在诊断方面，指南强调了增强CT和增强MRI在诊断肝门部胆管癌或远端胆管癌中的优势，尤其是对比超声，增强MRI结合MRCP对准确评估胆道梗阻的位置和范围更为优越。同时，因血清CA19-9水平存在较多非特异性增高的情况，不再推荐血清CA19-9水平作为辅助诊断肝外胆管癌的标准，但可作为肝门部胆管癌和远端胆管癌的预后生物学标志物。此外，指南还强调了组织学检查和细胞学检查的重要性，有条件时尽可能通过各种方法获得明确的组织学或细胞学诊断。04分期与治疗肝门部胆管癌分期依据明确：指南建议使用美国癌症联合委员会（AJCC）的TNM分期来指导临床决策。手术治疗指征更加明确：对于局部肝门部胆管癌患者，一般推荐R0切除。对于淋巴结阳性但局限于肝门部且术后死亡率可接受的患者，仍推荐手术治疗；对于肝外淋巴结转移的患者，则需进行术前新辅助治疗或转化手术治疗。同时明确，能够达到R0切除且需要进行门静脉或动脉重建的患者也可考虑手术。对于可手术治疗的肝外胆管癌患者，避免术前常规胆道引流，仅在发生胆管炎、肾衰竭、顽固性瘙痒、高胆红素值、新辅助化疗、计划进行广泛手术、预计手术等待时间较长的情况下考虑术前胆道引流。对于可手术治疗的远端胆管癌患者，若有胆道减压指征，优先推荐内镜引流而非经皮引流，若需支架则首选覆膜金属支架。对于处于早期，即T1、T2分期且肿瘤直径小于3厘米、N0、M0，但不可切除的肝门部胆管癌患者，可以考虑先行新辅助化疗和放疗，随后进行肝移植。对于已转移或存在侵犯的患者，切除后发现有浸润性病变、高复发风险，无论T、N分期及切缘状态如何，术后均建议给予辅助化疗，推荐单药卡培他滨方案。在晚期不可切除或转移性的肝外胆管癌患者的一线系统治疗中，基于TOPAZ-1和KEYNOTE-966试验，吉西他滨和顺铂联合PD-L1靶向抗体（度伐利尤单抗或帕博利珠单抗）被推荐为一线标准治疗方案，同时应该对所有不可手术患者进行分子分型，以识别可作用的变异，寻找靶向药物。上述方案都病情进展或未寻找到可作用靶点后，将FOLFOX方案视为二线系统治疗。《国际肝病》指南中推荐使用对比增强CT和MRI进行肝外胆管癌的诊断，并强调了其优于超声的价值。在实际临床工作中，您如何看待这些诊断技术的具体应用？它们对放射科医生和外科医生之间的协作提出了哪些新的要求或挑战？陆荫英教授01诊断技术的临床应用价值指南中推荐使用对比增强CT和增强MRI进行肝外胆管癌（包括肝门部胆管癌和远端胆管癌）的诊断。超声用于肝外胆管癌诊断时，准确性相对较低，尤其肝外胆管易受腹部肠道气体及结构影响较大，诊断效能不高。因此，指南明确指出，增强CT或增强MRI在诊断肝外胆管癌方面优于超声。增强CT和增强MRI能够提供更清晰的图像和更详细的解剖信息，有助于准确识别肿瘤的位置、大小、形态以及与周围组织的关系。另外，MRI的多平面成像能力使其在评估胆道梗阻的水平和范围方面具有独特优势。MRCP作为一种无创的胆道成像技术，可以清晰地显示胆管的狭窄部位和梗阻范围，为手术计划制定提供重要依据。除了形态学评估外，MRI还可以提供一些功能信息，如扩散加权成像（DWI）可以帮助区分良恶性病变，动态增强扫描可以评估肿瘤的血供情况，为诊断和鉴别诊断提供更多信息。02跨学科协作的新要求新指南对放射科医生和外科医生之间的协作提出了新的要求和挑战。在实际工作中，关键在于判断何时以及在何种情况下推荐患者进行增强CT或增强MRI检查。由于肝外胆管癌早期难以发现，超声可能仅在发生梗阻后才能发现异常，此时再推荐患者进行增强CT或增强MRI等更昂贵、复杂且有一定创伤的检查，存在一定的挑战。明确诊断后，增强CT和增强MRI，尤其是增强MRI结合MRCP，能够清晰判断肿瘤的具体位置和局部结构，以及胆道结构和梗阻情况。在有经验的放射科医生协作下，这些信息能帮助外科医生进行更精细的术前手术规划，意义重大。对于放射科医生和外科医生之间的协作，指南提出了新的要求。外科医生在手术前需与放射科医生共同读片，以提高手术规划的精准性。虽然外科医生读片水平已经很高，但随着分科细化，尤其在肝外胆管癌方面，放射科医生在解读影像的特殊表现上更为专业。因此，建立术前协作或MDT模式十分必要，这不仅能提升手术过程和选择的质量，也对外科医生的影像阅读水平提出了更高要求，同时也有助于外科医生提升这方面的能力。《国际肝病》对于局部晚期但不可切除的肝门部胆管癌患者，指南提出了新辅助化放疗后进行肝移植的策略。您认为在临床实践中推广这一策略可能面临哪些难点和挑战？陆荫英教授01术后复发风险极高，缺乏可靠循证证据术后复发是一个重大问题。肝移植术后需使用大量免疫抑制剂，而肝门部胆管癌恶性程度高、复发风险大。目前，新辅助化疗和放疗后再进行肝移植，并无明确数据支持可降低术后复发率。放疗作为局部治疗手段，并不能有效解决复发问题；化疗虽能在短期内控制肿瘤，但对远期复发的预防作用有限。不过，免疫治疗的出现为这一困境带来了新希望。若在术前采用化疗联合免疫治疗，甚至再加上靶向药物，进行综合治疗后再实施肝移植，有望降低术后复发概率，还需更多临床研究数据证实。目前指南仅推荐局部化疗和放疗后进行肝移植，但这种情况下术后仍有复发风险。02供体资源短缺与治疗成本的双重制约此外，推广该策略还面临经济成本和供体资源的挑战。肝移植手术费用高昂，且供体肝脏的获取也存在诸多困难。若在术前加入免疫治疗等新型疗法，治疗成本将进一步增加，这给患者家庭及医疗资源分配带来较大压力。同时，供体肝脏的分配需遵循严格的伦理和医学标准，有限的供体资源能否满足更多接受此类新辅助治疗后等待肝移植的患者需求，也是一个亟待解决的问题。《国际肝病》指南中讨论了遗传咨询在特定患者群体中的适用性。在实施这些建议时，您认为医生应如何平衡患者的知情权和可能引发的过度焦虑风险？考虑到当前肝外胆管癌治疗的挑战和争议，您认为未来研究应重点关注哪些方向？陆荫英教授01精准界定高风险人群，避免盲目扩大范围这是一个更具挑战性的问题，我也和其他同事讨论了这一问题。指南规定有相关病史的患者，可能是其他肿瘤病史而非胆道病史，这类患者可能属于肿瘤体质。此外，家族遗传或特定遗传基因改变，如胆道系统中类似乳腺癌的BRCA1/2基因突变，可能预示着胆道肿瘤高复发风险。对于这类患者，我们需要对他们强调遗传咨询的重要性，并使用通俗易懂的语言向患者解释遗传咨询的目的、过程和可能的结果，帮助患者建立了解自身病情及家族成员风险的主动意识。但是在沟通过程中，要充分尊重患者的意愿和选择，尊重患者的自主选择权。例如，我经常遇到CA19-9增高的患者，这类患者在过去一两年中几乎无法正常工作，一直处于焦虑状态。在这种情况下，心理医生的干预显得尤为重要，而非普通肿瘤医生或肝胆科医生的职责。我们会为患者制定规范化的随访方案，例如每三个月进行一次相关检查。但在随访过程中如何与患者沟通、使其知情，这是一个巨大挑战。即便这种情况发生在我们自己身上，也可能会过度焦虑。因此，解决问题的关键在于找到更精准、更敏感的生物标志物，这与患者的早筛问题相关。02早筛与风险干预：从 “被动诊断” 到 “主动预防”目前肝外胆管癌治疗面临的挑战和争议主要集中在两个方面：一是早筛。对于高复发风险患者，如胆道系统慢性炎症或有遗传基因突变的患者，我们如何判断早期生物标志物，以及这些标志物在何时、以何种强度预测肿瘤发生。二是如何改变患者的高风险体质。我们通过遗传表现、疾病史或家族病史发现患者属于高风险人群，同时相关标志物也提示高风险。在肿瘤发生前，我们发现患者可能是高风险人群，肿瘤标志物升高，预示着半年、一年或两年内可能发生肿瘤。那么如何处理这类患者？若给予肿瘤治疗药物，这属于过度治疗。因此，如何降低标志物水平、改变高风险状态，这一领域尚属空白。我认为中医中药在此可发挥重要作用。中医“治未病”的理念能够在这方面进行干预。我们今年获得的国家重点研发计划正是聚焦于此，探索如何通过中医中药改变患者的体质和症候，降低肿瘤风险。03精准诊疗：构建多模态风险评估与复发防控体系此外，我们还需建立更精准的多参数、多模态风险评估模型，这需要前瞻性地建立队列。我们正在与胆道一线专家合作，将高风险人群、慢性胆道系统炎症患者纳入队列，结合中医和西医方法，期望在3至5年内建立起更精准的胆道系统肿瘤风险评估模型，从而精准指导患者，解决过度焦虑问题。术后复发是另一个重大挑战。对于肝门部胆管癌、肝外胆管癌或胆道肿瘤患者，外科手术是最直接、最有效的解决方法，但术后复发风险高。目前指南推荐卡培他滨用于预防复发，但其预防效能有限。如今我们有了靶免药物以及多种治疗模式，还有肠道微生态调理、代谢调理等。未来能否通过这些方法显著降低术后复发风险，是一个值得尝试且极具潜力的研究方向。会场花絮（来源：《国际肝病》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床研究

100 项与卡培他滨相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D01223	卡培他滨	L01BC06	DB01101

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
胃食管交界处癌	美国	CHEPLAPHARM Arzneimittel GmbH	2022-12-14
胰腺癌	美国	CHEPLAPHARM Arzneimittel GmbH	2022-12-14
直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2016-09-19
食管癌	澳大利亚	Dr. Reddy's Laboratories (Australia) Pty Ltd.	2013-06-24
局部晚期乳腺癌	欧盟	Accord Healthcare SLU	2012-04-20
局部晚期乳腺癌	欧盟	KRKA dd	2012-04-20
局部晚期乳腺癌	欧盟	Teva Pharmaceuticals Europe BV	2012-04-20
局部晚期乳腺癌	冰岛	Accord Healthcare SLU	2012-04-20
局部晚期乳腺癌	冰岛	Teva Pharmaceuticals Europe BV	2012-04-20
局部晚期乳腺癌	冰岛	KRKA dd	2012-04-20
局部晚期乳腺癌	列支敦士登	KRKA dd	2012-04-20
局部晚期乳腺癌	列支敦士登	Accord Healthcare SLU	2012-04-20
局部晚期乳腺癌	列支敦士登	Teva Pharmaceuticals Europe BV	2012-04-20
局部晚期乳腺癌	挪威	Teva Pharmaceuticals Europe BV	2012-04-20
局部晚期乳腺癌	挪威	Accord Healthcare SLU	2012-04-20
局部晚期乳腺癌	挪威	KRKA dd	2012-04-20
胃癌	中国	Chugai Pharmaceutical Co., Ltd.	2008-10-17
复发性乳腺癌	日本	CHEPLAPHARM Arzneimittel GmbH	2007-12-12
结肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2003-04-30
晚期胃癌	欧盟	CHEPLAPHARM Arzneimittel GmbH	2001-02-02

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
ER阳性/HER2阴性乳腺癌	临床3期	法国	UNICANCER	2020-06-11
GRPR阳性/ER阳性/HER2阴性乳腺癌	临床3期	法国	UNICANCER	2020-06-11
肝转移	临床3期	法国	UNICANCER	2020-06-11
转移性胃腺癌	临床3期	美国	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	日本	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	阿根廷	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	比利时	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	加拿大	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	捷克	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	丹麦	Eli Lilly & Co.	2015-01-20

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02595320 (ASCO2025)	临床2期	转移性乳腺癌	182	Fixed-dose Capecitabine 1500 mg	鑰壓製選鹽觸簾憲築壓(願壓顧鏇艱鹹築衊糧壓) = 襯鏇餘蓋簾艱壓膚觸選壓願壓憲鹹襯鹹簾憲憲 (餘積構鑰膚觸淵鏇夢壓 ) 更多	积极	2025-05-30
NCT02595320 (ASCO2025)	临床2期	转移性乳腺癌	182	Standard-dose Capecitabine 1250 mg	鑰壓製選鹽觸簾憲築壓(願壓顧鏇艱鹹築衊糧壓) = 糧憲齋襯築膚窪壓製觸壓願壓憲鹹襯鹹簾憲憲 (餘積構鑰膚觸淵鏇夢壓 ) 更多	积极	2025-05-30
ASCO2025	N/A	头颈部肿瘤	86	Capecitabine 500mg twice a day + Erlotinib 150mg daily	觸觸糧獵膚構構鹽繭範(淵網選壓繭鬱鏇鑰鹹鏇) = 製鏇選餘鏇鹽鑰鹽醖齋構膚憲築蓋積簾鹽淵淵 (範鑰壓鏇製糧壓網觸糧, 1.22 ~ 1.90) 更多	积极	2025-05-30
ASCO2025	N/A	食管鳞状细胞癌	50	Capecitabine plus Oxaliplatin (CapOx)	積淵鹽憲淵衊鹹製憲襯(壓鏇獵鑰選鏇艱獵願願) = mostly grade 1 & 2 and not significantly different in 2 arms 獵範願廠網鬱獵顧鏇齋 (淵窪糧積壓膚製夢膚齋 ) 更多	不佳	2025-05-30
ASCO2025	N/A	食管鳞状细胞癌	50	Paclitaxel plus Carboplatin (PC)		不佳	2025-05-30
NCT05064085 (Phase I trial of capecitabine with cemiplimab, ASCO2025)	临床1期	HR阳性乳腺癌	-	Capecitabine + Cemiplimab	襯築襯衊膚襯選窪衊獵(鑰糧襯鏇憲簾繭艱蓋餘) = 鑰願遞鹽製膚獵膚憲鏇簾顧蓋醖鹹壓夢糧遞繭 (衊壓淵築網窪餘網築簾, 35.5% ~ 82.3%) 更多	积极	2025-05-30
ATS2025	N/A	转移性乳腺癌辅助	-	Capecitabine	窪獵膚範淵鹽鏇鬱憲壓(獵積艱觸獵鹹廠網餘獵) = She started cycle #1 of capecitabine and 2 weeks later presented to the hospital with cough and dyspnea, requiring admission for sepsis secondary to viral pneumonia with lung infiltrates seen on imaging. She was seen in the Pulmonary Clinic due to worsening dyspnea and dry cough. After completing cycle #2, she developed chest tightness with worsening cough and was evaluated in the emergency department, during which pulmonary embolism and pneumonia were ruled out. She was given steroids again with good relief. Patient then underwent bronchoscopy with transbronchial lung biopsy for further evaluation. Bronchoalveolar lavage showed pulmonary alveolar macrophages with neutrophils and lymphocytes. Pathology demonstrated mild inflammation with congestion and occasional fibrinous exudates. Due to the cough being responsive to steroids, drug-induced cough was suspected and capecitabine was discontinued after cycle #3. Steroids were repeated with significant improvement in her cough. 膚衊淵鏇齋淵顧艱蓋積 (廠鹹艱齋積衊蓋憲憲齋 ) 更多	-	2025-05-16
P1-6.012 (AAN2025)	N/A	-	-	Capecitabine	築齋夢窪獵膚鹽艱艱築(範願鹹淵艱築積壓選鬱) = Neurological adverse effects are uncommon, typically presenting with acute confusion, ataxia, and dysarthria 網繭築觸糧觸窪膚壓觸 (膚鹹膚範艱獵繭顧鏇遞 ) 更多	-	2025-04-07
NCT03383679 (UCBG 3-06 START, Pubmed \| Lancet Oncol)	临床2期	晚期三阴性乳腺癌 AR positivity	94	Darolutamide 600 mg	網鏇選夢艱築蓋衊廠獵(遞糧簾夢選選網壓觸餘) = toxicoderma (n=1) and headache (n=2) in the darolutamide group, and diarrhoea, general physical deterioration, and hepatic cytolysis in the capecitabine group (n=1 each) 觸襯鏇鏇醖選獵積淵積 (願餘範構蓋鏇醖壓淵襯 ) 更多	不佳	2025-03-01
NCT03383679 (UCBG 3-06 START, Pubmed \| Lancet Oncol)	临床2期	晚期三阴性乳腺癌 AR positivity	94	Capecitabine minimum 1000 mg/m2		不佳	2025-03-01
NCT04380337 (SHORT-FOX, CTgov)	临床2期	直肠癌 \| 直肠腺癌	38	IMRT+LEUCOVORIN CALCIUM+irinotecan+oxaliplatin+capecitabine+Fluorouracil	廠壓糧築廠鹽繭憲齋網 = 壓膚簾鹽艱顧願觸餘襯鏇憲淵鹹願獵窪鹹築範 (積繭網糧壓衊廠餘顧築, 鏇鑰製窪願憲觸繭壓醖 ~ 窪網網醖鹹遞鹹鹹醖願) 更多	-	2025-02-25
NCT01972919 (CTgov)	临床2期	不能切除性胰腺癌	23	Radiation Therapy+Gemcitabine+Capecitabine	鬱鑰淵築遞鹹構網醖鏇 = 窪憲顧壓願廠獵衊醖壓膚鹹範鹹衊醖觸製觸築 (築壓壓衊願製淵觸選製, 積糧鹽簾夢鹹餘窪顧蓋 ~ 顧襯憲網艱遞糧鹹廠網) 更多	-	2025-02-10