卡培他滨(Capecitabine) - 药物靶点：TYMS_在研适应症：胃食管交界处癌，胰腺癌，直肠癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Capecitabine (JAN/USP/INN)、Capecitabine RDT、pentyl 1-(5-deoxy-β-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate

+ [18]

靶点

TYMS

作用方式

抑制剂

作用机制

TYMS抑制剂(胸苷酸合成酶抑制剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [6]

在研适应症

胃食管交界处癌胰腺癌直肠癌+ [23]

非在研适应症

腺癌胆道腺癌食管腺癌+ [95]

原研机构

F. Hoffmann-La Roche Ltd.

在研机构

Hoffmann-La Roche, Inc.

Pfizer Inc.Dr. Reddy's Laboratories (Australia) Pty Ltd.

+ [11]

非在研机构

Novartis Pharmaceuticals Corp.

Sanofi

Bristol Myers Squibb Co.

+ [18]

权益机构

青岛百洋医药股份有限公司

CHEPLAPHARM Arzneimittel GmbH

Roche Holding AG

最高研发阶段批准上市

首次获批日期

美国 (1998-04-30),

转移性乳腺癌

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)

登录后查看时间轴

结构/序列

分子式C15H22FN3O6

InChIKeyGAGWJHPBXLXJQN-UORFTKCHSA-N

CAS号154361-50-9

关联

2,213

项与卡培他滨相关的临床试验

NCT07113275

/ Not yet recruiting临床3期IIT

A National Multicenter, Randomized Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in High-Risk Locally Advanced Rectal Cancer

This study is a national multicenter, prospective randomized controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.

开始日期2026-01-01

申办/合作机构-

NCT07112053

/ Not yet recruiting临床2期IIT

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer

This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) or chemotherapy (CDK4/6 inhibitor or capecitabine) in treating patients with hormone receptor (HR) positive, HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Standard ET is treatment that adds, blocks, or removes hormones in order to slow or stop the growth of cancer. Standard CDK4/6 inhibitors may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Giving STEMVAC in combination with standard ET or chemotherapy may be an effective treatment for metastatic HR positive, HER2 negative breast cancer.

开始日期2026-01-01

申办/合作机构

University of Washington

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

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

12,456

项与卡培他滨相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Cost-effectiveness analysis of capecitabine versus active monitoring in stable or responding metastatic colorectal cancer after 16 weeks of first-line therapy

Article

作者: Yao, Ruihong ; Zhong, Lu ; Dong, Mei ; Liu, Tong ; Tong, Zhiqiang

BACKGROUND:

This study aimed to assess the cost-effectiveness of capecitabine versus active monitoring in stable or responding metastatic colorectal cancer (mCRC) after 16 weeks of first-line therapy.

METHODS:

A partitioned survival model (PSM) was constructed to determine the costs and effects of capecitabine and active monitoring based on FOCUS4-N trial data. The Chinese healthcare payer's perspective was considered with a lifetime horizon, including direct medical costs. Health outcomes were measured in quality-adjusted life years (QALYs). The cost-effectiveness was assessed by calculating the incremental cost-effectiveness ratio (ICER). A willing-to-pay (WTP) threshold was set at 37653 USD/QALY, which was three times the gross domestic product (GDP) per capita of China in 2021. We examined the robustness of the model in one-way and probabilistic sensitivity analysis (PSA).

RESULTS:

There was no significant difference between capecitabine arm and active monitoring arm in QALYs (0.93 vs 0.92). The total cost of capecitabine arm was higher than that of active monitoring (35 061.61 USD vs 13 677.18 USD), suggesting the capecitabine group was not cost-effective in stable or responding mCRC after 16 weeks of first-line therapy. The cost of capecitabine and active monitoring had the largest impact on the ICER through one-way sensitivity analysis. The PSA indicated a 100% probability that active monitoring arm was cost-effective under the WTP.

CONCLUSIONS:

Compared to active monitoring, maintenance treatment with capecitabine alone was not cost-effective in stable or responding mCRC after 16 weeks of first-line therapy.

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.

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.

1,174

项与卡培他滨相关的新闻（医药）

2025-09-02

·抗体圈

ADC：ORR不能作为替代终点！

▲多重福利来袭，点击即可预约替代终点（如PFS、ORR）在肿瘤临床试验中具有重要意义，可加速药物审批流程，使患者更快获得有效治疗。PFS长期以来被认为是晚期实体瘤化疗试验中OS的有效替代终点。但随着免疫治疗的出现如ADC，PFS或者ORR作为OS替代终点是否有效相关研究较少，最近来自于欧洲和美国的临床研究团队，对目前已经披露的ADC临床进行全面分析，PFS与最终的OS具有较强的相关性，因此理论上可以作为代替终点，而ORR是否可以作为代替终点和肿瘤类型相关。重要的是，今年8月，FDA发布了《癌症临床试验中总生存期评估新指南草案》，并明确要求：在可行情况下，总生存期（OS）应作为临床试验的主要终点。即使OS不作为主要终点，药企也必须收集并提交生存数据，以支持药物安全性和疗效的最终评价。这表明后续肿瘤药物申请将趋于更加严格。总体而言，该研究分析共纳入了25项随机对照试验（RCTs），总计11729名患者，表1和表S1显示了所纳入试验的主要特征。临床结果披露年份从2012年到2024年。4项研究是在一线治疗背景下进行的，21项是在后续治疗线中进行的。OS是4项临床试验的主要终点，PFS是14项临床试验的主要终点，ORR是3项临床试验的主要终点，PFS和OS是4项临床试验的共同主要终点。试验的中位随访时间（FUP）范围为7至54个月，样本量从121到991名患者不等。其中一个试验有三个治疗组，因此总共分析了26项治疗比较。21个研究比较ADC作为单药疗法的疗效，5个临床比较评估了ADC分别与以下药物的组合：用于乳腺癌患者的atezolizumab、capecitabine或pertuzumab；用于尿路上皮癌患者的pembrolizumab；或用于小细胞肺癌患者的carboplatin和etoposide。16项比较在晚期乳腺癌患者中测试了ADC。研究者通过基于所有比较数据估算回归方程，评估了治疗对OS的影响与替代终点ORR之间的关联。ORR相对风险（RR）与OS风险比（HR）之间存在轻微至中度的关联：R²为0.47（95% CI = 0.14 至 0.79），回归线的斜率为-0.31。在对肿瘤类型调整模型后，两种治疗效果之间的关联没有实质性改变（调整后R² = 0.47；95% CI = 0.11 至 0.83；）。在亚组分析中，在大多数探索的亚组中，ORR-RR与OS-HR之间的关联强度从差到中度不等，但有一个明显的例外，即在测试ADC用于乳腺癌的试验中，R²值为0.77（95% CI = 0.51 至 0.91），表明可能存在强关联。 PFS-HR与OS-HR之间的关联很强：R²为0.72（95% CI = 0.52 至 0.85），回归线的斜率为0.59（图1和2，B）。在按肿瘤类型调整的模型中，R²更高为0.79（95% CI = 0.66 至 0.92；图1）。LOOCV分析证实了该结果，提供的交叉验证调整后R²值为0.69（图S2，B）。在亚组分析中，在所有分析的亚组中，PFS-HR与OS-HR之间的关联强度从中度到强不等（图1和图S3-S6）。计算了PFS或ORR对于OS的替代阈值效应（STE）。对于PFS-HR，总体STE为0.63，并在不同探索亚组中介于0.49至0.82之间。对于ORR-RR，由于观察到ORR与OS之间的关联较弱，总体STE高达2.68，并且在所有探索的亚组中均无法估算，除了在测试ADC用于乳腺癌、使用可裂解linker（CL）、使用不可裂解linker（NC）或既往接受过>1线系统治疗的比较中，STE分别为1.41、3.50、2.36和1.58。同时，研究者也进行了一项敏感性分析，仅保留实验组中ADC作为单药疗法给药的21项比较。结果显示ORR-RR（R² = 0.75；95% CI = 0.57 至 0.86）和PFS-HR（R² = 0.75；95% CI = 0.53 至 0.88）均具有强替代性。总结 PFS是OS的强有力替代终点：研究证实，在ADC临床试验中，无进展生存期（PFS）是总生存期（OS）的一个非常可靠的替代终点。其决定性系数 R² = 0.79，达到了国际指南推荐的强关联标准（>0.7），并且在不同患者群体和ADC药物特征的各种亚组分析中结果一致。相比之下，客观缓解率（ORR）与OS的关联性较弱（R² = 0.47），表明仅凭肿瘤缩小不足以可靠预测生存获益。唯一的例外是在乳腺癌亚组中，ORR显示出较强的替代性（R² = 0.77）。该研究为监管机构基于PFS阳性结果加速批准ADC新药提供了强有力的证据支持。同时对仅基于高ORR加速批准（如曲妥珠单抗德鲁替康用于所有HER2阳性肿瘤）提出了警示。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

抗体药物偶联物临床结果免疫疗法多肽偶联药物ASCO会议

2025-09-02

·抗体密码

ADC：ORR不能作为替代终点！

替代终点（如PFS、ORR）在肿瘤临床试验中具有重要意义，可加速药物审批流程，使患者更快获得有效治疗。PFS长期以来被认为是晚期实体瘤化疗试验中OS的有效替代终点。但随着免疫治疗的出现如ADC，PFS或者ORR作为OS替代终点是否有效相关研究较少，最近来自于欧洲和美国的临床研究团队，对目前已经披露的ADC临床进行全面分析，PFS与最终的OS具有较强的相关性，因此理论上可以作为代替终点，而ORR是否可以作为代替终点和肿瘤类型相关。重要的是，今年8月，FDA发布了《癌症临床试验中总生存期评估新指南草案》，并明确要求：在可行情况下，总生存期（OS）应作为临床试验的主要终点。即使OS不作为主要终点，药企也必须收集并提交生存数据，以支持药物安全性和疗效的最终评价。这表明后续肿瘤药物申请将趋于更加严格。总体而言，该研究分析共纳入了25项随机对照试验（RCTs），总计11729名患者，表1和表S1显示了所纳入试验的主要特征。临床结果披露年份从2012年到2024年。4项研究是在一线治疗背景下进行的，21项是在后续治疗线中进行的。OS是4项临床试验的主要终点，PFS是14项临床试验的主要终点，ORR是3项临床试验的主要终点，PFS和OS是4项临床试验的共同主要终点。试验的中位随访时间（FUP）范围为7至54个月，样本量从121到991名患者不等。其中一个试验有三个治疗组，因此总共分析了26项治疗比较。21个研究比较ADC作为单药疗法的疗效，5个临床比较评估了ADC分别与以下药物的组合：用于乳腺癌患者的atezolizumab、capecitabine或pertuzumab；用于尿路上皮癌患者的pembrolizumab；或用于小细胞肺癌患者的carboplatin和etoposide。16项比较在晚期乳腺癌患者中测试了ADC。研究者通过基于所有比较数据估算回归方程，评估了治疗对OS的影响与替代终点ORR之间的关联。ORR相对风险（RR）与OS风险比（HR）之间存在轻微至中度的关联：R²为0.47（95% CI = 0.14 至 0.79），回归线的斜率为-0.31。在对肿瘤类型调整模型后，两种治疗效果之间的关联没有实质性改变（调整后R² = 0.47；95% CI = 0.11 至 0.83；）。在亚组分析中，在大多数探索的亚组中，ORR-RR与OS-HR之间的关联强度从差到中度不等，但有一个明显的例外，即在测试ADC用于乳腺癌的试验中，R²值为0.77（95% CI = 0.51 至 0.91），表明可能存在强关联。 PFS-HR与OS-HR之间的关联很强：R²为0.72（95% CI = 0.52 至 0.85），回归线的斜率为0.59（图1和2，B）。在按肿瘤类型调整的模型中，R²更高为0.79（95% CI = 0.66 至 0.92；图1）。LOOCV分析证实了该结果，提供的交叉验证调整后R²值为0.69（图S2，B）。在亚组分析中，在所有分析的亚组中，PFS-HR与OS-HR之间的关联强度从中度到强不等（图1和图S3-S6）。计算了PFS或ORR对于OS的替代阈值效应（STE）。对于PFS-HR，总体STE为0.63，并在不同探索亚组中介于0.49至0.82之间。对于ORR-RR，由于观察到ORR与OS之间的关联较弱，总体STE高达2.68，并且在所有探索的亚组中均无法估算，除了在测试ADC用于乳腺癌、使用可裂解linker（CL）、使用不可裂解linker（NC）或既往接受过>1线系统治疗的比较中，STE分别为1.41、3.50、2.36和1.58。同时，研究者也进行了一项敏感性分析，仅保留实验组中ADC作为单药疗法给药的21项比较。结果显示ORR-RR（R² = 0.75；95% CI = 0.57 至 0.86）和PFS-HR（R² = 0.75；95% CI = 0.53 至 0.88）均具有强替代性。总结 PFS是OS的强有力替代终点：研究证实，在ADC临床试验中，无进展生存期（PFS）是总生存期（OS）的一个非常可靠的替代终点。其决定性系数 R² = 0.79，达到了国际指南推荐的强关联标准（>0.7），并且在不同患者群体和ADC药物特征的各种亚组分析中结果一致。相比之下，客观缓解率（ORR）与OS的关联性较弱（R² = 0.47），表明仅凭肿瘤缩小不足以可靠预测生存获益。唯一的例外是在乳腺癌亚组中，ORR显示出较强的替代性（R² = 0.77）。该研究为监管机构基于PFS阳性结果加速批准ADC新药提供了强有力的证据支持。同时对仅基于高ORR加速批准（如曲妥珠单抗德鲁替康用于所有HER2阳性肿瘤）提出了警示。我们已经建立抗体密码读者交流群，有兴趣的可以扫描下方二维码添加微信进群，请主动备注姓名-公司-职位（高校-专业），非诚勿扰！往期精彩回顾抗体密码文章合集双特异抗体平台靶点相关双特异抗体作用机制综述，行业概览抗体筛选技术相关公司技术汇总医药资讯因为你的分享、点赞、在看我足足的精气神儿！声明本公众号所发表文章以宣传知识为目的，因此不构成投资，病人用药等建议。如果文章侵您的权益及时联系小编进行删除！欢迎扫码交流/咨询/合作=

抗体药物偶联物临床结果多肽偶联药物免疫疗法

2025-08-29

·Biotech前瞻

胃癌化疗怎么选？—FLOT、mFOLFOX6、CAPOX的一文读懂

三种方案各是什么？ FLOT：多西他赛 + 奥沙利铂 + 亚叶酸 + 5-FU（三联），多用于围手术期（术前4周期开刀术后再4周期），q2w给药。其III期FLOT4研究证实了总生存获益，是能耐受三联患者的“强力方案”。 mFOLFOX6：奥沙利铂 + 亚叶酸 + 5-FU（双联，含持续泵），多用在围手术期不耐受三联者或转移/晚期一线，q2w给药。 CAPOX（XELOX）：卡培他滨（口服）+ 奥沙利铂（静滴）（双联），常用于D2术后辅助和转移/晚期一线，q3w给药。三种方案如何选择 1）可切除局部晚期（≥cT2或N+）—“围手术期”怎么选？首选：FLOT（能耐受三联者）。与老方案ECF/ECX相比，FLOT4显示5年生存率由36%提高到45%；ESMO将其列为可耐受三联患者的标准方案（ESMO-MCBS 评分A）。不耐受三联（年龄大、PS差、合并症多等）→ 选含奥沙利铂的双联：mFOLFOX6 或 CAPOX 作为折中。国内外指南明确认可这一路径。一句话口诀：能扛三联上FLOT；扛不住，就上“双联”（mFOLFOX6/CAPOX）。 2）已做D2胃切除但术前没做新辅助—“术后辅助”怎么选？亚洲证据更强：CAPOX/XELOX。 CLASSIC研究结果，确立了在基于东亚人群的研究结果中，以奥沙利铂为基础的XELOX方案改变了胃癌治疗格局，显著改善了胃癌患者的长期生存，确立了该方案用于胃癌患者术后辅助化疗的获益。XELOX方案也因此被写入国内胃癌诊疗指南。何时偏向mFOLFOX6？口服耐受差/吸收障碍、胃肠术后恢复慢、或肾功能明显受限（卡培他滨需按肾功能调整甚至禁用）时，更偏静脉mFOLFOX6。卡培他滨在肌酐清除30–50 mL/min需起始减量，<30 mL/min不推荐。一句话：D2术后常规CAPOX优先；口服不便或肾功差→mFOLFOX6。 3）转移/晚期一线——mFOLFOX6 vs CAPOX谁更好？疗效：总体相当。多项回顾与整合证据显示，口服卡培他滨与静脉5-FU在胃癌中的总体生存/无进展生存差异不显著，因此mFOLFOX6 与 CAPOX 并列为一线基石选择，再按生物标志物叠加免疫或靶向（HER2、PD-L1等）。如何二选一（实操点）：倾向CAPOX：想减少输液、重视生活便利、依从性好（门诊口服为主，q3w）。倾向mFOLFOX6：吞咽/吸收问题、近期大手术胃肠道恢复差、明显肾功能下降（卡培他滨受限）、不适应手足综合征。两者均有奥沙利铂累积性周围神经病变风险；部分中心采用“停开停走（stop-and-go）”策略减神经毒性。一句话：mFOLFOX6 ≈ CAPOX，按生活方式 + 器官功能个体化选择。毒性与便利性对照给药便利：CAPOX（门诊口服为主，少输液，q3w）＞ mFOLFOX6（需输液泵，q2w）＞ FLOT（强度高，q2w）。典型不良反应：卡培他滨：手足综合征/腹泻更常见，且需按肾功能调整剂量（CrCl 30–50 mL/min起始减25%，<30 mL/min禁用/不推荐）。奥沙利铂：周围神经病变与累计剂量相关，可影响长期生活质量；必要时“减量/暂停”以平衡疗效与神经毒性。 FLOT：疗效强，但骨髓抑制、胃肠道反应等总体更重，需更密切支持治疗（止吐、G-CSF二级预防等），由经验团队把控。 💡 关注Biotech视野了解自己，关爱家人，健康并非遥不可及~

临床3期临床结果上市后研究免疫疗法

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,

登录

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	KRKA dd	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	Teva Pharmaceuticals Europe BV	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,

登录

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


NCT06246461 (Pubmed \| J Chemother) 人工标引	N/A	结肠癌	150	capecitabinep (2,500 mg/m^2)	餘醖襯餘構顧製築餘艱(艱鹽鏇艱鹹製製鏇餘願) = 憲獵衊鏇齋選艱築獵襯夢淵糧鹹糧餘壓夢窪積 (構顧觸遞築觸鏇齋繭壓 ) 更多	积极	2025-07-04
				capecitabinegroup (2,000 mg/m^2)	餘醖襯餘構顧製築餘艱(艱鹽鏇艱鹹製製鏇餘願) = 淵鏇鏇廠構製觸鑰夢憲夢淵糧鹹糧餘壓夢窪積 (構顧觸遞築觸鏇齋繭壓 ) 更多
BILCAP (ESMO_GI2025)	临床3期	辅助 CD80	304	Capecitabine	壓願構構獵鏇製夢遞淵(鹹襯鑰築製蓋鏇蓋觸夢) = 齋蓋壓鑰憲淵餘膚鹹遞窪鹹糧積願醖膚鑰積艱 (艱鏇壓淵醖膚鬱範鏇簾 ) 更多	积极	2025-07-03
				capecitabine (Observation)	壓願構構獵鏇製夢遞淵(鹹襯鑰築製蓋鏇蓋觸夢) = 壓廠觸顧鹽遞壓憲獵構窪鹹糧積願醖膚鑰積艱 (艱鏇壓淵醖膚鬱範鏇簾 ) 更多
IKF/AIO-ADJUBIL (ESMO_GI2025)	临床2期	胆道癌辅助	40	Durvalumab + Tremelimumab	糧鏇製簾窪齋願範繭網(範壓鏇壓築願夢膚膚網) = 鏇簾製構範構糧餘襯顧窪獵鏇鬱鹽繭顧膚積構 (遞鏇鹽鑰積積艱窪網淵 ) 更多	积极	2025-07-03
				Durvalumab + Tremelimumab + Capecitabine	糧鏇製簾窪齋願範繭網(範壓鏇壓築願夢膚膚網) = 製範顧鹹壓餘簾夢鬱蓋窪獵鏇鬱鹽繭顧膚積構 (遞鏇鹽鑰積積艱窪網淵 ) 更多
ESMO_GI2025	N/A	结肠癌辅助	54	S-1	廠選選憲夢鏇選鏇選製(艱齋願淵鏇襯顧築鏇壓) = 7% (n=2, both grade 1) of patients during S-1 treatment 齋艱夢選醖選鏇蓋襯製 (蓋蓋壓餘獵壓鹹簾鹹壓 ) 更多	积极	2025-07-03
NCT03904043 (NOM-ERA, CTgov)	N/A	直肠腺癌	63	Radiation therapy (Radiation + FOLFOX)	鬱獵築築觸遞衊獵蓋顧 = 餘窪遞蓋蓋遞壓積鬱顧壓鑰選鏇選願鬱衊築鏇 (構構鹽築簾憲築構築襯, 糧積網顧壓顧艱鹹製範 ~ 襯鹽鑰齋鹹醖鹽淵淵構) 更多	-	2025-06-11
				Radiation therapy+oxaliplatin+capecitabine (Radiation + CAPOX)	鬱獵築築觸遞衊獵蓋顧 = 鏇範構鬱觸鹹糧遞膚積壓鑰選鏇選願鬱衊築鏇 (構構鹽築簾憲築構築襯, 衊餘願衊憲築壓廠範網 ~ 積襯觸膚簾簾餘蓋範網) 更多
NCT01354522 (Pubmed \| Cancer Commun (Lond))	临床3期	HER2 阴性乳腺癌辅助	204	Docetaxel, Anthracycline, Cyclophosphamide (TAC)	憲淵淵蓋膚餘選廠鏇製(積遞糧膚獵簾醖選壓膚) = 淵顧築壓鏇遞選壓選製淵築壓鏇鏇繭願願艱餘 (遞鹽選顧選願範鬱壓蓋, 3.9) 更多	积极	2025-06-09
				Docetaxel, Cyclophosphamide, Capecitabine (TCX)	憲淵淵蓋膚餘選廠鏇製(積遞糧膚獵簾醖選壓膚) = 鹹製窪襯壓齋憲糧願觸淵築壓鏇鏇繭願願艱餘 (遞鹽選顧選願範鬱壓蓋, 4.7) 更多
["PECORINO"] (Pubmed \| J Gastrointest Oncol)	临床3期	胃癌新辅助	69	FLOT (5-fluorouracil, leucovorin, oxaliplatin and docetaxel)	選壓窪齋糧鏇衊簾鹹獵(鹹鏇襯夢淵廠積遞餘獵) = 繭鬱鏇網築憲築鹹壓淵艱廠觸夢鬱窪構網積觸 (齋餘蓋憲願築鹽淵遞繭, 31.9 ~ 65.6)	积极	2025-06-01
				XELOX (capecitabine and oxaliplatin)	選壓窪齋糧鏇衊簾鹹獵(鹹鏇襯夢淵廠積遞餘獵) = 衊鬱鹽壓簾繭繭觸願糧艱廠觸夢鬱窪構網積觸 (齋餘蓋憲願築鹽淵遞繭, 8.9 ~ 39.8)
NCT04849364 (PERSEVERE, CTgov)	临床2期	三阴性乳腺癌	52	pembrolizumab+inavolisib+capecitabine (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway)	窪獵鏇鬱鹹鏇觸選衊艱 = 醖積衊構淵遞膚築蓋憲製構簾鏇廠鬱餘壓壓衊 (夢衊積鹽製願範鹹餘鹽, 夢鹽膚夢鑰築窪衊願膚 ~ 觸夢糧簾築淵餘淵蓋鏇) 更多	-	2025-05-31
				Pembrolizumab+Capecitabine (Arm 2: ctDNA Positive - Standard of Care)	繭繭觸網鹹簾齋積艱衊 = 鬱鏇淵繭鹽顧鹹鬱選簾蓋願齋窪網淵觸膚簾膚 (夢網繭簾齋壓鬱築獵窪, 範網廠憲膚淵憲餘鑰淵 ~ 壓築糧鏇製淵廠網糧獵) 更多
ASCO2025	N/A	食管鳞状细胞癌	50	Capecitabine plus Oxaliplatin (CapOx)	鏇築構願淵齋構糧願簾(網蓋蓋網獵艱餘艱範遞) = mostly grade 1 & 2 and not significantly different in 2 arms 鑰觸遞鏇製觸範壓窪願 (範顧積範蓋簾繭鏇衊簾 ) 更多	不佳	2025-05-30
				Paclitaxel plus Carboplatin (PC)
ASCO2025	N/A	头颈部肿瘤	86	Capecitabine 500mg twice a day + Erlotinib 150mg daily	鬱鹽鹹衊製壓鏇積鏇願(襯遞鏇構壓淵鹽鬱鹹窪) = 範製築糧觸繭鬱遞鏇構願鹹憲糧壓衊壓衊顧糧 (壓獵醖餘鹽襯顧願廠淵, 1.22 ~ 1.90) 更多	积极	2025-05-30