预约演示
更新于：2026-04-04
Folinic Acid/Fluorouracil
亚叶酸/氟尿嘧啶
更新于：2026-04-04
概要
基本信息
结构/序列
分子式C4H3FN2O2 |
InChIKeyGHASVSINZRGABV-UHFFFAOYSA-N |
CAS号51-21-8 |
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关联
25
项与 亚叶酸/氟尿嘧啶 相关的临床试验NCT07235202
An Open-label, Dose-escalation and Dose-expansion Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MR001 in Combination With Standard Chemotherapy Regimens in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Who Have Progressed After First-line Therapy
NCT07283367
A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 Combination Therapies in Patients With Advanced Colorectal Cancer.
ChiCTR2600119904
Irinotecan Liposome (II) in Combination with 5-FU/LV, Bevacizumab, with or without Camrelizumab as First-Line Treatment for MSS/pMMR Metastatic Colorectal Cancer: A Randomized, Open-Label, Exploratory Clinical Study
100 项与 亚叶酸/氟尿嘧啶 相关的临床结果
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100 项与 亚叶酸/氟尿嘧啶 相关的转化医学
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100 项与 亚叶酸/氟尿嘧啶 相关的专利（医药）
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87
项与 亚叶酸/氟尿嘧啶 相关的文献（医药）2025-08-01Asian Pacific journal of cancer prevention : APJCP
The Ideal Second-Line Treatment Options for Patients with Advanced Biliary Tract Cancer Refractory to Gemcitabine-Based First-Line Chemotherapy: A Result From Bayesian Network-Meta Analysis
Article
作者: Aryanti, Citra ; Syarifuddin, Erwin
OBJECTIVE:
To determine the most ideal second-line treatment for advanced biliary tract cancer, considering the response rate, survival, and drug adverse events.
METHODS:
This network meta analysis (NMA) was conducted in accordance with the PRISMA with NMA extension guidance. After formulation of PICO, comprehensive searches of literatures were done including all randomized controlled studies that reported the second-line treatment for advanced biliary tract cancers' subjects who have failed with first-line gemcitabine-based chemotherapy. The outcomes analyzed were response rate, progression-free survival, overall survival, and serious adverse events. Data were collected and analysis will be done based on Bayesian method using BUGSnet package in R studio.
RESULTS:
Eleven eligible RCTs were included in this NMA with 1228 subjects and 15 different second-line therapies. The NMA was conducted in random-effects, consistent, and convergence model. Most studies reported the use of fluoropyrimidine-based regimen, either alone or in combination with others drugs. The combination of 5FU-LV with liposomal irinotecan showed the most favorable outcomes, the highest response rate, longest overall survival, and longest progression-free survival. However, this regimen had highest adverse events among others. The next promising regimen was combination of oral capecitabine with varlitinib, with favorable response rate (RR 16.67; 95%CI 0.01 to 21.39), overall survival (HR 0.09; 95%CI -5.22 to 5.37), and progression-free survival (HR 1.37; 95%CI -58.4 to 62.15). The serious adverse events were reported less than others.
CONCLUSION:
The combination of oral capecitabine with varlitinib could be a promising second-line treatment for patients with advanced biliary tract cancer refractory to gemcitabine-based first-line regimen.
2025-04-15Cancer Research and Treatment
Second-Line Fluoropyrimidine-Based Chemotherapy in Advanced Biliary Tract Cancer: A Meta-analysis Based on Individual Patient-Level Data of Randomized Trials
Article
作者: Choi, In Sil ; Kim, Jin Won ; Kang, Minsu ; Park, Jin Hyun ; Cheon, Jaekyung ; Ryu, Hyewon ; Kim, Kyu-Pyo ; Ryoo, Baek-Yeol ; Hyung, Jaewon ; Abou-Alfa, Ghassan K ; Kim, Ji-Won ; Abou-Alfa, Ghassan K. ; Lee, Ji Sung ; Yoo, Changhoon ; Kim, Kyu-pyo ; Kim, Ilhwan
PurposeWhile fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head.Materials and Methods We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens. Results A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy.Conclusion Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.
2025-03-01JOURNAL OF GASTROENTEROLOGY
Efficacy of liposomal irinotecan + 5-FU/LV vs. S-1 in gemcitabine-refractory metastatic pancreatic cancer: a real-world study using inverse probability of treatment weighting
Article
作者: Okuyama, Hiroyuki ; Okano, Naohiro ; Hosokawa, Ayumu ; Imaoka, Hiroshi ; Suzuki, Rei ; Naganuma, Atsushi ; Sakamoto, Yasunari ; Kobayashi, Noritoshi ; Nebiki, Hiroko ; Kawaguchi, Shinya ; Negoro, Yuji ; Shioji, Kazuhiko ; Terashima, Takeshi ; Kawata, Kazuhito ; Ueno, Masayuki ; Murohisa, Gou ; Morizane, Chigusa ; Doi, Toshifumi ; Asagi, Akinori ; Suzuki, Yuko ; Nagano, Hiroaki ; Kobayashi, Satoshi ; Tsuji, Kunihiro ; Ohba, Akihiro ; Ohyama, Hiroshi ; Shimizu, Satoshi ; Ikeda, Masafumi ; Tsumura, Hidetaka ; Kitano, Yohei ; Ashida, Reiko ; Kimura, Nana ; Nakachi, Kohei ; Kawamoto, Yasuyuki ; Furuse, Junji ; Ueno, Makoto ; Shibata, Ryusuke ; Umemoto, Kumiko
Abstract:
Background:
S-1 monotherapy had previously been widely used as a second-line treatment for pancreatic cancer (PC) after gemcitabine-based chemotherapy mainly in Japan. Based on the results of the NAPOLI-1 trial, the recommended second-line therapy is now liposomal irinotecan plus fluorouracil/folinic acid (nal-IRI + 5-FU/LV). However, there have been no studies comparing nal-IRI + 5-FU/LV therapy with S-1 monotherapy.
Methods:
The main objective of this study was to compare overall survival (OS) in patients treated with nal-IRI + 5-FU/LV and those treated with S-1 monotherapy as second-line treatments, using the inverse probability of treatment weighting (IPTW) method. This study was conducted in 31 institutions participating in Japan Oncology Network in Hepatobiliary and Pancreas. To minimize potential biases due to the retrospective design, IPTW analysis was performed with multiple imputation, and imputed IPTW-adjusted hazard ratios and corresponding 95% confidence intervals (CIs) were estimated using a Cox proportional hazards model and combined into pooled estimates.
Results:
A total of 463 metastatic PC patients were enrolled in this study (257 in the S-1 monotherapy group and 206 in the nal-IRI + 5-FU/LV group). The median OS was 7.50 months (95% CI 4.18–12.69 months) in the nal-IRI + 5-FU/LV group and 5.72 months (95% CI 2.76–10.79 months) in the S-1 monotherapy group. In the IPTW-adjusted Cox proportional hazards model, nal-IRI + 5-FU/LV was associated with a significant OS benefit (pooled IPTW-adjusted hazard ratio, 0.779; 95% CI 0.399—0.941; p = 0.025).
Conclusion:
These findings support the use of nal-IRI + 5-FU/LV as standard second-line treatment for PC patients after gemcitabine-based chemotherapy.
100 项与 亚叶酸/氟尿嘧啶 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局部晚期胰腺腺癌 | 临床2期 | 中国 | 2024-10-16 | |
| 中枢神经系统肿瘤 | 临床1期 | 澳大利亚 | - | 2023-01-30 |
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临床结果
临床结果
适应症
分期
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临床3期 | 二线 | 55 | 糧製憲齋構顧衊衊顧衊(範淵網積觸鹽顧獵淵餘) = occurred in 33% (n = 6) of pts without MA and 100% (n = 7) of pts with ascites grade 3 襯壓鹽夢鑰積鏇繭遞膚 (範鏇觸壓網積鏇繭顧鑰 ) 更多 | 不佳 | 2025-07-03 | ||
临床1期 | 19 | 鬱蓋壓遞繭獵網選蓋窪(糧衊積鏇選廠醖糧觸鑰) = Grade 1/2 adverse events were fatigue, mucositis, and diarrhea. 構製夢窪廠廠艱淵鏇衊 (艱範鹽壓醖鏇鑰壓範餘 ) 更多 | 积极 | 2024-01-18 | |||
临床2期 | 93 | Control Treatment (FP/Bevacizumab) | 築選築鹹製壓淵艱鹽鹽(淵餘觸蓋憲蓋積膚繭遞) = 願襯鏇願餘蓋鹽廠醖願 醖衊鏇衊艱夢憲觸夢鑰 (簾願獵遞廠鬱糧鏇衊鑰 ) 更多 | - | 2021-07-03 | ||
築選築鹹製壓淵艱鹽鹽(淵餘觸蓋憲蓋積膚繭遞) = 壓選鑰糧遞鹹糧獵鏇網 醖衊鏇衊艱夢憲觸夢鑰 (簾願獵遞廠鬱糧鏇衊鑰 ) 更多 | |||||||
N/A | 结直肠癌 辅助 | 551 | 鏇觸襯觸廠鏇艱構繭選(醖衊願餘鏇膚夢鹽鏇製): HR = 0.14 (95% CI, 0.02 ~ 0.66), P-Value = 0.013 更多 | 积极 | 2018-06-20 | ||
临床3期 | - | 膚蓋遞遞鑰願艱淵鏇鏇(醖蓋遞遞積窪鬱網夢願) = 獵構醖築糧醖鹹鬱選衊 壓鹹膚淵廠醖衊廠觸憲 (壓餘築淵製願觸構遞憲 ) | - | 2017-06-28 | |||
膚蓋遞遞鑰願艱淵鏇鏇(醖蓋遞遞積窪鬱網夢願) = 鏇蓋製蓋廠齋壓積獵壓 壓鹹膚淵廠醖衊廠觸憲 (壓餘築淵製願觸構遞憲 ) | |||||||
临床1期 | - | 40 | 鹹鹽築壓廠膚築艱積憲(鬱蓋獵廠壓製觸鬱選獵) = No > grade 1 toxicity was noted at 375-475 mg/m² bolus, or at 1200-2400 mg/m² infusion. The DLT in bolus schedule was grade 3 diarrhea and myelosuppression at 575 mg/m², with no DLT in the infusion schedule at the maximum dose 3600 mg/m². Other grade 3 toxicities were nausea, vomiting, and raised liver function tests. 餘遞淵構獵築襯鑰顧獵 (選齋膚蓋淵願網繭艱鏇 ) | - | 2017-05-30 | ||
N/A | 12 | FOLFIRINOX induction | 淵夢構鹽鬱顧鑰壓顧繭(憲範繭顧夢觸夢餘淵壓) = 遞觸憲淵壓築製積蓋鏇 願製鑰顧夢願遞鑰膚鏇 (壓窪鏇繭鹹積鏇積襯遞 ) | - | 2012-05-20 | ||
N/A | 129 | Chrono-IFLO | 糧選窪鬱窪網衊鏇襯鹹(鹹範獵壓製鑰膚壓築艱) = 積簾獵鑰餘遞選構窪簾 衊鑰範淵獵繭壓齋窪蓋 (鏇蓋積顧蓋憲鬱夢積網 ) 更多 | - | 2011-05-20 | ||
Chrono-IFLO + Cetuximab | 糧選窪鬱窪網衊鏇襯鹹(鹹範獵壓製鑰膚壓築艱) = 夢構鹹膚壓選網製簾觸 衊鑰範淵獵繭壓齋窪蓋 (鏇蓋積顧蓋憲鬱夢積網 ) 更多 | ||||||
临床2期 | 转移性结直肠癌 维持 | - | 獵窪鑰觸網衊遞襯壓積(鏇願艱醖襯選願蓋網夢) = 網鹽憲醖顧醖遞蓋顧鬱 製繭襯壓齋築遞鏇範壓 (構鹹範網積繭網選襯網 ) | 不佳 | 2011-02-01 | ||
Placebo | 獵窪鑰觸網衊遞襯壓積(鏇願艱醖襯選願蓋網夢) = 膚鑰獵遞選簾夢襯選糧 製繭襯壓齋築遞鏇範壓 (構鹹範網積繭網選襯網 ) | ||||||
临床2期 | 34 | 5-fluorouracil/leucovorin in combination with paclitaxel and oxaliplatin (POF) | 憲構鹽顧遞襯構選繭鏇(網選鹹蓋範構鏇鬱製顧) = 獵膚齋醖憲築築壓齋鬱 艱繭衊築餘壓艱構廠願 (簾網繭網窪鹽簾選簾簾 ) 更多 | - | 2010-05-20 |
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