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

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100 项与卡培他滨相关的转化医学

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100 项与卡培他滨相关的专利（医药）

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13,576

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·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.

1,132

项与卡培他滨相关的新闻（医药）

2025-07-15

·肿瘤界

《柳叶刀-肿瘤学》| 靖昌庆/李乐平团队发表局部晚期直肠癌全程新辅助放化疗联合免疫治疗临床研究成果

点击蓝字关注我们2025年7月8日，由山东第一医科大学附属省立医院（山东省立医院）胃肠外科靖昌庆教授、李乐平教授领衔消化道肿瘤多学科诊疗团队开展的一项临床研究“Total neoadjuvant treatment with short-course radiotherapy followed by sintilimab plus capecitabine–oxaliplatin versus short-course radiotherapy followed by capecitabine–oxaliplatin in patients with locally advanced rectal cancer (SPRING-01): a single-centre, open-label, phase 2, randomised controlled trial”，以原创研究形式在线发表在The Lancet Oncology。研究结果显示，在局部晚期直肠癌患者中，短程放疗联合信迪利单抗及CAPOX作为全程新辅助治疗可显著提高病理完全缓解率，且安全性可控。这一方案有望成为局部晚期直肠癌的新型新辅助治疗策略。山东第一医科大学附属省立医院胃肠外科靖昌庆、李乐平教授为本论文共同通讯作者，胃肠外科副主任医师田锋、肿瘤研究治疗中心副主任医师戴洪海、肿瘤微创综合治疗科主任医师沙丹、消化内科副主任医师于源滋、病理科副主任医师井海燕、医学影像科主任医师孙丛为论文共同第一作者，山东第一医科大学附属省立医院为本研究独立第一作者及通讯作者单位。局部晚期直肠癌既往标准治疗模式为先进行新辅助放化疗、随后实施全直肠系膜切除手术，术后继续辅助化疗，这一治疗模式可以使局部晚期直肠癌病理完全缓解率（pCR）达到15%左右，如何进一步提高pCR率降低局部复发率、提高保肛率和提高生活质量是目前直肠癌临床研究的热点。SPRING-01是一项单中心、开放标签、II期随机对照试验。符合直肠癌新辅助放化疗条件的入组患者接受短程放疗（5 Gy*5次），放疗结束1周后，试验组接受6个周期的信迪利单抗（PD-1免疫检查点抑制剂）联合CAPOX方案化疗，对照组仅为CAPOX方案化疗。全程新辅助治疗完成后2–3周进行根治性直肠全系膜切除术（TME）。主要研究终点为ITT人群病理完全缓解率。研究设计SPRING-01 研究结果显示：与CAPOX对照组相比，试验组信迪利单抗联合CAPOX组显著提高了病理完全缓解率pCR（59.2% vs 32.7%；P=0.015），完全缓解率cCR（61.2% vs 32.7%；P=0.0085）和主要病理缓解率MPR（73.5% vs 46.9%；P=0.013）。89例患者接受了腹腔镜手术，其中两组间的R0切除率无显著差异。两组患者在术后并发症方面无统计学差异，最常见的术后并发症为低白蛋白血症，且两组均未发生3级及以上术后并发症。在新辅助治疗期间，3–4级治疗相关不良事件两组患者无统计学差异。常见的3–4级不良事件为血小板减少，白细胞减少，贫血，腹泻及发热。3级以上免疫治疗相关不良事件发生率为12%，包括心肌炎、肾损伤、肺炎、结肠炎和皮炎等，无免疫治疗相关死亡。疗效评估在局部晚期直肠癌患者中，短程放疗联合信迪利单抗及CAPOX作为全程新辅助治疗可显著提高病理完全缓解率，且安全性可控。部分低位局部晚期直肠癌患者经过严格评估临床完全缓解后，甚至可以采用观察和等待的方案，避免手术带来的创伤和生活质量的降低。这一方案有望成为局部晚期直肠癌的新型新辅助治疗策略。SPRING-01研究入选了2025年美国临床肿瘤学会年会（ASCO）口头报告，靖昌庆教授于美国芝加哥时间2025年6月1日对SPRING-01研究进行了口头报告，报告内容引起了世界各国与会学者的关注和热烈讨论，同时也吸引了多家国内外医疗媒体的采访和报道。国外医疗领域在线视频教育平台特邀研究团队针对SPRING01研究以视频形式进行专题报告。随着SPRING-01主要研究终点的完成，与其相关的EFS和OS生存预后指标也在随访中，将对这一新型治疗模式做出进一步评价。与此同时，有关免疫联合放化疗治疗局部进展期直肠癌的SPRING-02、SPRING-03系列研究也正在进行中，后续将进一步优化该疾病新辅助治疗策略，提高治疗有效性的同时降低毒副反应并为患者保肛甚至豁免手术提供高级别循证医学证据。供稿：胃肠外科声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：山东第一医科大学附属省立医院微信公众号原标题：山东第一医科大学附属省立医院靖昌庆、李乐平教授团队在国际顶级医学期刊发表局部晚期直肠癌全程新辅助放化疗联合免疫治疗临床研究成果编辑：南星审校：lagertha

临床结果放射疗法免疫疗法临床2期

2025-07-14

·华昊中天

优替德隆胶囊用于三阴性乳腺癌辅助治疗临床III期完成首例患者入组

中国北京，2025年7月14日，北京华昊中天生物医药股份有限公司（下称“华昊中天”，股票代码：2563.HK），一家依托于合成生物学研发平台专注于开发具有自主知识产权抗癌新药的生物医药公司，今日宣布，“优替德隆胶囊（UTD2）联合卡培他滨对比卡培他滨单药用于新辅助治疗后未达到病理完全缓解的三阴性早期乳腺癌辅助治疗的多中心、开放、随机、对照的 III 期临床试验”（NCT07021261）成功实现首例患者用药。本研究主要研究者为复旦大学附属肿瘤医院大外科主任兼乳腺外科主任邵志敏教授。乳腺癌是全球女性最常见的恶性肿瘤，中国2020年年龄标化的乳腺癌发病率达到 39.1/10 万，新发乳腺癌达41.6万例，占全球每年新发乳腺癌总人数的18.4%[1]。近年来，随着乳腺癌筛查项目的推广，初诊乳腺癌人群中早期乳腺癌的比例不断提高，越来越多的患者具有手术治疗的机会。乳腺癌术前新辅助治疗和术后辅助治疗成为乳腺癌综合治疗中非常重要的组成部分。三阴性乳腺癌（TNBC）作为一种恶性程度高、预后较差的乳腺癌亚型，由于以往缺乏明确的治疗靶点，治疗进展相对缓慢，其新辅助和辅助化疗的推荐治疗方案以蒽环/紫杉类药物为主[2]，但由于这类药物本身的毒性风险，足疗程治疗后未达到病理完全缓解（non-pCR）患者可选择的辅助治疗方案非常有限，临床需求迫切。优替德隆注射液已于2021年获批上市，实现晚期乳腺癌患者无进展生存期（PFS）和总生存期（OS）双获益。基于此，优替德隆用于乳腺癌前线治疗的场景正在被不断拓展，其用于HER2阴性早期高危或局部晚期乳腺癌新辅助治疗的Ⅲ期临床正在进行中，有望替代紫杉类成为HER2-乳腺癌新辅助化疗首选（新闻链接：优替德隆丨乳腺癌新辅助Ⅲ期注册临床完成首例患者入组）。UTD2是优替德隆的口服剂型，充分利用了优替德隆不易被P-糖蛋白泵出胞外、可以口服给药的优势。其确切的疗效、良好的安全性和较高的口服生物利用度已通过中国和美国临床研究得到充分验证，目前多项II/III期临床正在开展中（新闻链接：新适应症再获国际多中心临床批准丨优替德隆胶囊治疗铂耐药卵巢癌II/III期、新闻链接：FDA批准华昊中天优替德隆胶囊一线治疗晚期胃癌II/III期国际多中心临床）。考虑到口服给药将显著提升患者用药便利性和依从性从而有助于长期治疗，可以预见，UTD2将在乳腺癌辅助治疗领域展现巨大的应用潜力，从而使优替德隆贯穿性布局于晚期乳腺癌、乳腺癌新辅助和辅助治疗中，造福更广泛的乳腺癌患者人群。关于NCT07021261研究该研究为一项“优替德隆胶囊（UTD2）联合卡培他滨对比卡培他滨单药用于新辅助治疗后未达到病理完全缓解的三阴性早期乳腺癌辅助治疗的多中心、开放、随机、对照的 III 期临床研究”，目的是评价UTD2联合卡培他滨对比卡培他滨单药用于新辅助治疗后未达到病理完全缓解的三阴性早期乳腺癌辅助治疗的有效性和安全性。计划入组440 例患者，按1:1随机分配至试验组和对照组。研究主要终点为3年无侵袭性疾病生存（IDFS）率；次要终点包括5年IDFS率、3年OS率、5年OS率和安全性。研究由复旦大学附属肿瘤医院大外科主任兼乳腺外科主任邵志敏教授牵头。参考文献[1]中国抗癌协会乳腺癌专业委员会,中国抗癌协会国际医疗交流分会,中国医师协会肿瘤医师分会乳腺癌学组. 中国晚期三阴性乳腺癌临床诊疗指南（2024 版）[J]. 中华肿瘤杂志,2024,46(06)：471-480. [2]中国临床肿瘤学会乳腺癌诊疗指南2024版.往期回顾100%临床获益率丨优替德隆一线治疗晚期胃癌/食管癌II期临床数据亮相2025 ASCO68% CNS-ORR丨优替德隆治疗乳腺癌脑转移Ⅱ期临床数据亮相2025 ASCO单药82%临床获益丨优替德隆胶囊治疗晚期实体瘤美国Ⅰ期临床数据亮相2025 ASCO新适应症再获国际多中心临床批准丨优替德隆胶囊治疗铂耐药卵巢癌II/III期华昊中天荣登2025年度生物制造·未来智药TOP10斩获ASCO 2025口头报告丨华昊中天优替德隆多项临床研究成果齐亮相FDA批准华昊中天优替德隆胶囊一线治疗晚期胃癌II/III期国际多中心临床一图回顾华昊中天2024年度进展 Biostar 2024 Annual Review华昊中天荣获“年度卓越创新力IPO”奖强强联合，携手共赢丨华昊中天与百洋医药达成战略合作华昊中天成功登陆香港联交所主板，合成生物学引领创新药研发新时代华昊中天“优替德隆注射液乳腺癌新辅助Ⅲ期注册临床试验”研究者会议圆满召开本资讯仅供医学专业人士参考，不构成任何诊疗建议

临床3期上市批准CSCO会议

2025-07-13

·ioncology

ESMO GI 主席观点丨Teresa Macarulla Mercade教授：消化道肿瘤电场治疗的机制及研究进展

编者按2025年7月2日-5日，欧洲肿瘤内科学会消化道肿瘤年会（ESMO GI）在西班牙巴塞罗那盛大召开，汇聚了全球消化道领域最新研究进展。会上，ESMO GI大会主席Teresa Macarulla Mercade 系统介绍了消化道肿瘤治疗电场治疗的机制及研究进展。TTFields通过便携设备发出的电场无创作用于肿瘤部位，可以干扰癌细胞分裂关键过程，增强抗肿瘤免疫应答。TTFields联合全身系统治疗已获批用于胶质母细胞瘤（GBM）、恶性胸膜间皮瘤（MPM）和转移性非小细胞肺癌（NSCLC）。在消化道肿瘤领域，PANOVA系列研究证实TTFields联合吉西他滨±白蛋白紫杉醇治疗晚期胰腺癌患者疗效可观且耐受性良好，极具发展前景。在消化道恶性肿瘤中，胰腺癌是过去十年间整体生存率提升最有限[1]且五年生存率最低的肿瘤之一[2]，是消化道肿瘤领域的重大挑战，亟待开发能实质性改善预后的创新疗法。TTFields作为一种新型物理治疗模式，通过便携设备发生电场无创作用于肿瘤部位，具有巨大潜力。TTFields设备包含电场发生器和置于体表的电极贴片阵列，以胰腺癌为例，可通过在患者体表皮肤上贴装四个电极贴片阵列实现治疗（图1）[3]。图1.胰腺癌电场治疗示意图：腹部有效电场分布目前已有多项临床前及临床研究证实了TTFields在胰腺癌的治疗效果。体外实验数据及原位移植瘤模型[4,5]证实TTFields具有抗肿瘤活性，且与化疗药物存在协同作用（图2）。当前临床实践中，多以吉西他滨联合紫杉醇作为TTFields的治疗搭档[6]。图2.临床前研究证实TTFiels与化疗具有协同作用PANOVA试验[7]是一项多中心、开放标签、Ⅱ期单臂临床试验，共纳入40例晚期胰腺癌的患者，予以TTFields联合吉西他滨±白蛋白紫杉醇进行治疗。结果显示，主要研究终点安全性方面，21例患者报告了治疗相关的皮肤不良事件，其中7例为3级不良事件，经过减量后缓解，未见严重不良事件。次要研究终点显示，TTFields联合吉西他滨组的中位无进展生存期（mPFS）为8.3个月，中位总生存期（mOS）为14.9个月；TTFields联合吉西他滨及白蛋白紫杉醇组的mPFS为12.7个月，比单用吉西他滨联合紫杉醇的效果更好（图3），为进一步探索奠定了基础。图3. PANOVA试验的mPFS与mOS基于PANOVA研究结果，Teresa Macarulla Mercade教授启动了前瞻性、开放标签、国际多中心、Ⅲ期随机对照试验——PANOVA-3研究[8]，旨在进一步验证TTFields联合化疗在晚期胰腺癌中的疗效及安全性。该研究纳入556例局部晚期、非转移性、未经治疗的胰腺癌患者，按1:1的比例随机分组，TTFields联合吉西他滨及白蛋白紫杉醇作为干预组，吉西他滨/白蛋白紫杉醇作为对照组（图4）。主要评估指标是OS，次要评估指标是PFS、生活质量和肿瘤切除率以及药物的安全性和耐受性。图4. PANOVA-3研究设计该研究部分数据已在2025年的美国临床肿瘤学会年会（ASCO）会议公布并发表于《临床肿瘤学杂志（JCO）》[8]，此次ESMO GI会议上Teresa Macarulla Mercade教授以最新进展突破（LBA）形式报告了该研究的生活质量及癌痛表现结果[9]。PANOVA-3研究结果显示，TTFields联合化疗方案的mOS具有显著优势，与单纯化疗相比（mOS 14.2个月），联合治疗显著延长mOS至16.2个月，风险比（HR）为0.819（95%CI 0.676-0.991），P=0.039（图5）。mOS绝对值差异达2个月，与NAPOLI-3研究[10]表现一致。图5.PANOVA-3研究的主要研究终点-OS该研究TTFields组和单纯化疗组的mPFS无显著差异，为10.6个月 vs 9.3个月，HR为0.84（95% CI, 0.68-1.05），P=0.137；局部PFS亦无显著性差异（HR=0.84，P=0.151），可能与原发灶疗效评估困难有关。TTFields联合化疗组患者的远处无进展生存期（dPFS）达13.8个月，较单纯化疗组（dPFS 为11.5个月）延长2.3个月，HR为0.74（95%CI 0.57-0.96），P=0.022（图6）。图6. PANOVA-3研究的PFS及dPFS无痛生存期是该研究的重要指标，TTFields联合化疗组的无痛生存期较单纯化疗组延长6个月（15.2个月 vs 9.1个月），HR为0.74（95%CI 0.56-0.97），P=0.027，具有显著的临床优势，对常伴复杂疼痛的局部晚期胰腺癌患者具有重要临床价值（图7）。图7. PANOVA-3试验的无痛生存期TTFields联合化疗组还具有更好的客观缓解率（ORR：36.1% vs 30.0%）。在安全性方面，TTFields联合化疗组较化疗未增加全身性毒性，因不良事件导致TTFields相关治疗中断率仅8.4%，主要为皮肤不良反应所致，整体安全可耐受。除了与化疗联合外，TTFields与免疫治疗也具有协同机制。TTFields可通过低强度交变电场破坏微管聚合，干扰癌细胞有丝分裂，诱导肿瘤子代细胞染色体非整倍体化，促使肿瘤细胞进入应激状态，导致免疫原性死亡，从而显著提升全身的抗肿瘤反应（图8）[11,12]。该机制已在动物肺癌模型中获初步验证，显示TTFields治疗后肿瘤免疫浸润显著增加[13]，确证了TTFields增强肿瘤免疫原性的特点，从而为其他肿瘤如胰腺癌等的免疫疗法提供了新的策略方向。图8. TTFields增强免疫治疗效果的机制在TTFields增强免疫疗效的机制下，Teresa Macarulla Mercade教授启动了单臂Ⅱ期PANOVA-4试验（EudraCT 2022-003157-55）[14]，计划纳入76例转移性胰腺癌患者，采用TTFields联合阿替利珠单抗+吉西他滨+白蛋白紫杉醇方案一线治疗，主要终点为疾病控制率（DCR），目前已完成患者招募，值得期待（图9）。目前，TTFields已在多种消化道肿瘤中展开了探索。在肝癌方面，Ⅱ期HEPANOVA研究[15]采用TTFields联合索拉非尼治疗一线治疗晚期肝细胞癌（HCC），结果显示，TTFields联合索拉非尼组治疗超过12周患者的ORR达到18%，mPFS为8.9个月，1年OS率为64%，提示与靶向治疗的协同潜力。在胃/胃食管癌方面，Ⅱ期EF-31/ZL-8301-001研究[16]，TTFields联合化疗方案（卡培他滨/奥沙利铂）治疗不可手术局部晚期或转移性胃/胃食管癌可实现50%的ORR，mPFS为8个月，mOS为12个月，较既往的化疗存在优势趋势。总之，TTFields通过诱导实体瘤免疫原性细胞死亡，联合化疗一线治疗可以显著改善胰腺癌患者OS及无痛生存期，安全性可控。基于该机制，TTFields联合免疫治疗、靶向治疗等策略已在胰腺癌、肝癌和胃癌等消化道肿瘤中展开探索，极具前景。Dra. Teresa Macarulla西班牙巴塞罗那Vall d'Hebron大学医院肿瘤内科 GI和内分泌肿瘤部门主任西班牙肿瘤临床学会、欧洲肿瘤内科学会和美国临床肿瘤学会活跃成员2025 ESMO GI大会主席参考文献上下滑动查看更多内容[1] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34.[2] Oberstein PE, Olive KP. Pancreatic cancer: why is it so hard to treat? Therap Adv Gastroenterol. 2013 Jul;6(4):321-37.[3] NAVEH A, BOMZON Z, FARBER O, et al. Abstract 3204: transducer array configuration optimization for treatment of pancreatic cancer using tumor treating fields (TTFields)[J]. Cancer Research, 2018, 78(13_Supplement): 3204-3204.[4] Giladi M, Schneiderman RS, Porat Y, Munster M, Itzhaki A, Mordechovich D, Cahal S, Kirson ED, Weinberg U, Palti Y. Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Pancreatology. 2014 Jan-Feb;14(1):54-63.[5] Jo Y, Oh G, Gi Y, et al. Tumor treating fields (TTF) treatment enhances radiation-induced apoptosis in pancreatic cancer cells. Int J Radiat Biol. 2020;96(12):1528-1533. doi:10.1080/09553002.2020.1838658[6] GILADI M, SCHNEIDERMAN R S, PORAT Y, et al. Abstract 5569: tumor treating fields inhibit the growth of pancreatic and ovarian cancer in preclinical models[J]. Cancer Research, 2013, 73(8_Supplement): 5569-5569.[7] Rivera F, Benavides M, Gallego J, Guillen-Ponce C, Lopez-Martin J, Küng M. Tumor treating fields in combination with gemcitabine or gemcitabine plus nab-paclitaxel in pancreatic cancer: Results of the PANOVA phase 2 study. Pancreatology. 2019 Jan;19(1):64-72.[8] BABIKER H M, PICOZZI V, CHANDANA S R, et al. Tumor treating fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase III PANOVA-3 study[J]. Journal of Clinical Oncology, 2025, 0(0): JCO-25-746.[9] Teresa MM, Vincent JP, et al. PANOVA-3: Pain and quality of life (QoL) outcomes with Tumor Treating Fields (TTFields) therapy in patients with locally advanced pancreatic adenocarcinoma (LAPC). 2025 ESMO GI LBA3.[10] Wainberg ZA, Melisi D, Macarulla T, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023;402(10409):1272-1281. doi:10.1016/S0140-6736(23)01366-1[11] Mun EJ, Babiker HM, Weinberg U, Kirson ED, Von Hoff DD. Tumor-Treating Fields: A Fourth Modality in Cancer Treatment. Clin Cancer Res. 2018 Jan 15;24(2):266-275.[12] Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046.[13] Kirson ED, Schneiderman RS, Dbalý V, Tovarys F, Vymazal J, Itzhaki A, Mordechovich D, Gurvich Z, Shmueli E, Goldsher D, Wasserman Y, Palti Y. Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). BMC Med Phys. 2009 Jan 8;9:1.[14] SEUFFERLEIN T, CUBILLO GRACIAN A, KUENG M. PANOVA-4 (EF-39): pilot study of tumor treating fields (TTFields) therapy with atezolizumab, gemcitabine (GEM), and nab-paclitaxel (NabP) as first-line (1L) treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC)[J]. Journal of Clinical Oncology, 2024, 42(3_suppl): TPS718-TPS718.[15] Gkika E, Grosu AL, Macarulla Mercade T, Cubillo Gracián A, Brunner TB, Schultheiß M, Pazgan-Simon M, Seufferlein T, Touchefeu Y. Tumor Treating Fields Concomitant with Sorafenib in Advanced Hepatocellular Cancer: Results of the HEPANOVA Phase II Study. Cancers (Basel). 2022 Mar 18;14(6):1568.[16] LI J, CANG S, LING Y, et al. LBA3 tumor treating fields (TTFields) therapy plus XELOX chemotherapy for front line treatment of advanced unresectable gastroesophageal junction adenocarcinoma (GEJC) or gastric adenocarcinoma (GC): a multicenter phase II trial[J]. Annals of Oncology, 2022, 33: S1455.（来源：《肿瘤瞭望》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2期临床3期

100 项与卡培他滨相关的药物交易

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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,

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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	Teva Pharmaceuticals Europe BV	2012-04-20
局部晚期乳腺癌	欧盟	KRKA dd	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	Accord Healthcare SLU	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	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,

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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

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临床结果

适应症

分期

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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


ESMO_GI2025	N/A	结肠癌辅助	54	S-1	憲鬱鹹選鹽壓膚願願鬱(獵願鹹簾憲糧淵範繭壓) = 7% (n=2, both grade 1) of patients during S-1 treatment 顧膚繭顧淵鏇顧鹹窪鏇 (鑰醖觸願夢範鹽夢遞廠 ) 更多	积极	2025-07-03
BILCAP (ESMO_GI2025)	临床3期	辅助 CD80	304	Capecitabine	構顧衊簾蓋廠築顧衊衊(範鏇顧蓋壓鬱膚築獵廠) = 製構齋襯顧窪膚構鏇簾構憲顧遞餘艱鬱夢遞積 (蓋網繭構壓憲憲願膚鹽 ) 更多	积极	2025-07-03
				capecitabine (Observation)	構顧衊簾蓋廠築顧衊衊(範鏇顧蓋壓鬱膚築獵廠) = 襯壓願鏇鑰餘範壓簾壓構憲顧遞餘艱鬱夢遞積 (蓋網繭構壓憲憲願膚鹽 ) 更多
IKF/AIO-ADJUBIL (ESMO_GI2025)	临床2期	胆道癌辅助	40	Durvalumab + Tremelimumab	窪簾衊網範艱鏇齋鏇獵(廠網夢構鬱淵廠獵構淵) = 廠蓋淵願窪範選襯範壓鹽餘繭鑰繭窪艱壓遞壓 (憲廠淵觸顧鏇鹽網願選 ) 更多	积极	2025-07-03
				Durvalumab + Tremelimumab + Capecitabine	窪簾衊網範艱鏇齋鏇獵(廠網夢構鬱淵廠獵構淵) = 壓鏇範壓壓製鏇顧網糧鹽餘繭鑰繭窪艱壓遞壓 (憲廠淵觸顧鏇鹽網願選 ) 更多
NCT03904043 (NOM-ERA, CTgov)	N/A	直肠腺癌	63	Radiation therapy (Radiation + FOLFOX)	鏇觸製鑰衊淵積齋繭鹽 = 繭襯廠獵築製夢簾夢構遞鹽鏇觸築鹹繭願鹹範 (鬱襯獵構糧網憲製範醖, 鏇鏇鏇範窪鏇糧夢齋壓 ~ 淵鹽構糧艱遞構夢獵觸) 更多	-	2025-06-11
				Radiation therapy+oxaliplatin+capecitabine (Radiation + CAPOX)	鏇觸製鑰衊淵積齋繭鹽 = 襯夢範簾遞願糧構網鬱遞鹽鏇觸築鹹繭願鹹範 (鬱襯獵構糧網憲製範醖, 膚醖窪簾窪構鏇積襯製 ~ 簾顧齋鏇網觸遞憲窪繭) 更多
NCT01354522 (Pubmed \| Cancer Commun (Lond))	临床3期	HER2 阴性乳腺癌辅助	204	Docetaxel, Anthracycline, Cyclophosphamide (TAC)	簾窪憲願繭醖鹹餘壓選(願觸獵築蓋積憲積製蓋) = 鏇夢夢鏇衊鑰淵鹹鬱廠鑰鹹構範鑰廠窪範觸遞 (艱製網積壓壓築構衊顧, 3.9) 更多	积极	2025-06-09
				Docetaxel, Cyclophosphamide, Capecitabine (TCX)	簾窪憲願繭醖鹹餘壓選(願觸獵築蓋積憲積製蓋) = 簾窪淵觸鹽窪簾獵蓋網鑰鹹構範鑰廠窪範觸遞 (艱製網積壓壓築構衊顧, 4.7) 更多
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)	醖壓鬱糧網齋艱鏇獵繭 = 製選衊簾顧餘襯醖築醖廠簾遞遞膚夢鏇願遞遞 (積鹽鹽糧鹹鹹鑰觸鹽淵, 齋齋願窪窪餘淵鬱鹽簾 ~ 廠糧鬱鏇艱選餘製衊顧) 更多	-	2025-05-31
				Pembrolizumab+Capecitabine (Arm 2: ctDNA Positive - Standard of Care)	襯餘遞鹹齋簾獵製憲繭 = 襯餘獵鑰齋廠鏇簾製襯網觸顧選鏇構製顧醖憲 (襯鹽顧衊願構齋齋艱範, 淵壓艱鹹鑰餘鹹築簾醖 ~ 艱顧夢窪壓窪顧夢範齋) 更多
NCT05064085 (Phase I trial of capecitabine with cemiplimab, ASCO2025)	临床1期	HR阳性乳腺癌	-	Capecitabine + Cemiplimab	繭襯獵艱蓋鏇鑰鹹範蓋(範壓蓋憲餘衊網鹹簾窪) = 顧選壓顧顧壓積餘製襯網廠網壓廠襯網繭選壓 (廠選夢憲淵蓋獵繭築範, 35.5% ~ 82.3%) 更多	积极	2025-05-30
ASCO2025	N/A	食管鳞状细胞癌	50	Capecitabine plus Oxaliplatin (CapOx)	鬱醖憲積簾觸襯願壓艱(窪鬱範觸觸憲鑰顧窪襯) = mostly grade 1 & 2 and not significantly different in 2 arms 獵積積遞壓糧齋蓋構膚 (網鬱蓋製壓遞範鏇壓築 ) 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	鏇觸構鏇製膚鏇製範鬱(窪廠積夢艱範鹹鬱淵繭) = 壓衊積簾選範製廠築蓋構鏇鑰顧膚鬱鏇繭膚糧 (餘觸艱願壓夢夢構夢夢, 1.22 ~ 1.90) 更多	积极	2025-05-30
NCT02595320 (ASCO2025)	临床2期	转移性乳腺癌	182	Fixed-dose Capecitabine 1500 mg	範齋壓觸憲醖襯鏇艱鬱(築鑰鏇襯襯獵蓋鏇構齋) = 築積鹽鹹憲築壓膚獵醖艱顧夢繭構遞淵餘糧衊 (襯壓鑰獵構糧糧憲鹽遞 ) 更多	积极	2025-05-30
				Standard-dose Capecitabine 1250 mg	範齋壓觸憲醖襯鏇艱鬱(築鑰鏇襯襯獵蓋鏇構齋) = 範鹽簾襯壓艱網鏇觸網艱顧夢繭構遞淵餘糧衊 (襯壓鑰獵構糧糧憲鹽遞 ) 更多