FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) (TORCH-PM02)
2026年9月8日 更新者：Zhen Zhang、Fudan University
FAPI-Guided Hypofractionated Radiotherapy Combined With Cadonilimab and Standard Second-Line Chemotherapy Versus Standard Second-Line Chemotherapy for Peritoneal Metastasis From Colorectal Cancer: A Multicenter, Randomized, Open-Label, Phase III Trial (TORHC-PM02)
The goal of this clinical trial is to test whether adding targeted radiation plus cadonilimab immunotherapy to standard second-line chemo works better for adults with colorectal cancer only spread to the peritoneum, and check how safe this combined treatment is. Its main research questions are:
Does the combined treatment slow cancer growth for a longer time than standard chemo alone? What side effects will participants get from the new combination therapy? Researchers will compare the chemo-radiation-immunotherapy combination against standard chemo alone to see if the new plan shrinks tumors and improves outcomes.
Participants will:
Receive either the new combined treatment or standard chemo chosen randomly by chance Visit the hospital regularly for drug infusions, scans and physical exams Complete questionnaires about daily quality of life and report any discomfort
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
198
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhen Zhang, MD, PhD
- 电话号码：18801735029
- 邮箱：zhen_zhang@fudan.edu.cn
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200032
- Fudan University Shanghai Cancer Center
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接触：
- Zhen Zhang, Prof.
- 电话号码：+8618017312301
- 邮箱：zhenzhang_@fudan.edu.cn
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接触：
- Zhiyuan Zhang, M.D.
- 电话号码：+86 18916733704
- 邮箱：zhangzhiyuan.1994@163.com
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首席研究员：
- Zhen Zhang, Ph.D, M.D.
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首席研究员：
- Guoxiang Cai, Ph.D, M.D.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Histopathologically confirmed colorectal adenocarcinoma.
- Tumors confirmed pMMR by immunohistochemistry or MSI-L/MSS via gene sequencing.
- Metastases limited to peritoneum only, no metastases in other organs.
- No moderate or massive ascites; only trivial physiological effusion without drainage requirement.
- No symptomatic intestinal obstruction and no obstructive signs on imaging; patients can take food normally.
- Baseline CT/MRI confirms peritoneal metastases.
- Positive baseline FAPI PET/CT: at least one peritoneal mass lesion with long diameter ≥1 cm and markedly elevated SUVmax suitable for radiotherapy contouring.
- At least one measurable lesion per RECIST v1.1 criteria.
- Progression after first-line standard systemic therapy (FOLFOX/XELOX ± targeted agents); no prior second-line treatment received.
- Peritoneal recurrence within 1 year after adjuvant fluoropyrimidine-based chemotherapy.
- No moderate or massive ascites; only trivial physiological effusion without drainage requirement.
- Voluntarily sign written informed consent and comply with scheduled study visits and treatment procedures.
Exclusion Criteria:
- Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or other agents targeting T-cell co-stimulatory/checkpoint pathways.
- Moderate or massive ascites requiring clinical intervention.
- Partial or complete symptomatic intestinal obstruction.
- Pregnant or breastfeeding women.
- History of high-dose abdominal radiotherapy that prevents re-irradiation.
- Diffuse miliary peritoneal metastases on FAPI PET/CT without definable target volume for radiotherapy.
- Active autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.); systemic corticosteroids or other immunosuppressants required within 14 days before enrollment; severe underlying vital organ disease judged unsuitable for immunotherapy by investigators.
- Poor compliance or other conditions judged inappropriate for study participation by investigators.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Chemo-immunotherapy plus FAPI-guided radiotherapy
Participants receive standard second-line chemotherapy combined with cadonilimab immunotherapy given every two weeks.
They also receive hypofractionated radiotherapy guided by FAPI PET/CT to treat peritoneal tumor masses.
Radiation doses are adjusted to protect the small intestine.
After every eight weeks of treatment, a multidisciplinary team assesses whether surgery is possible.
Treatment continues until cancer worsens or side effects become too severe to tolerate.
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All chemotherapy agents are given by intravenous infusion every 2 weeks with oxaliplatin, leucovorin and continuous infusion fluorouracil, or irinotecan, leucovorin and continuous infusion fluorouracil.
Targeted agents bevacizumab or cetuximab can be added per investigator's clinical judgment.
Dose adjustments are allowed for myelosuppression, gastrointestinal or other toxicities.
Radiation target volumes are contoured on fused FAPI PET/CT images for peritoneal masses ≥1 cm.
Fraction doses range from 5 Gy to 25 Gy over 5 fractions, modified to meet small intestine organ-at-risk constraints.
Radiation is delivered within the first 8 weeks of combined chemoimmunotherapy treatment.
Cadonilimab is a PD-1/CTLA-4 dual-target biologic agent.
The fixed dose of 6 mg/kg is infused intravenously once every 2 weeks alongside chemotherapy.
Dose delay or permanent discontinuation will be applied for grade 3-4 immune-related adverse events that do not improve with immunosuppressive treatment.
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有源比较器：Standard second-line chemotherapy only
Participants receive standard second-line chemotherapy every two weeks.
No immunotherapy or radiation treatment is provided in this group.
Treatment continues until cancer worsens or side effects become too severe to tolerate.
Tumor assessment will be performed after 8 weeks of therapy, a multidisciplinary team assesses whether surgery is possible.
Treatment continues until cancer worsens or side effects become too severe to tolerate.
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All chemotherapy agents are given by intravenous infusion every 2 weeks with oxaliplatin, leucovorin and continuous infusion fluorouracil, or irinotecan, leucovorin and continuous infusion fluorouracil.
Targeted agents bevacizumab or cetuximab can be added per investigator's clinical judgment.
Dose adjustments are allowed for myelosuppression, gastrointestinal or other toxicities.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-Free Survival (PFS)
大体时间：Up to 36 months after randomization
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Time from randomization to first documentation of tumor progression (including enlargement of target lesions, new distant metastases, or new onset of ascites) or death from any cause, whichever occurs first, assessed per RECIST v1.1.
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Up to 36 months after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Survival (OS)
大体时间：OS is defined from randomization until death from any cause up to 36 months.
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Survival duration from randomization until death from any cause.
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OS is defined from randomization until death from any cause up to 36 months.
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Objective Response Rate (ORR)
大体时间：The best overall tumor response will be assessed every 8 weeks after the participant begins study treatment by scheduled MDT assessment through study completion, up to 36 months.
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The best overall tumor response rate, defined as the proportion of participants achieving confirmed complete response or partial response assessed via imaging based on RECIST 1.1 criteria and verified by multidisciplinary team review.
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The best overall tumor response will be assessed every 8 weeks after the participant begins study treatment by scheduled MDT assessment through study completion, up to 36 months.
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Disease Control Rate (DCR)
大体时间：The best overall disease control rate will be assessed every 8 weeks after the participant begins study treatment by scheduled MDT assessment through study completion, up to 36 months.
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The best overall disease control rate, defined as the proportion of participants with confirmed complete response, partial response or stable disease assessed via imaging based on RECIST 1.1 criteria and verified by multidisciplinary team review.
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The best overall disease control rate will be assessed every 8 weeks after the participant begins study treatment by scheduled MDT assessment through study completion, up to 36 months.
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Treatment-related adverse events
大体时间：Side effects will be recorded from the participant's first study treatment dose with radiotherapy and system treatment every cycle to 30 days after their final study treatment dose through study completion, up to 36 months.
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Incidence and severity of treatment side effects graded by NCI CTCAE v6.0.
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Side effects will be recorded from the participant's first study treatment dose with radiotherapy and system treatment every cycle to 30 days after their final study treatment dose through study completion, up to 36 months.
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Quality of life( QoL)
大体时间：At baseline and radiotherapy period will be reorded once, at system treatments QoL will be reported and recorded every 8 weeks regularly during the treatment through study completion, up to 36 months.
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Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment.
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At baseline and radiotherapy period will be reorded once, at system treatments QoL will be reported and recorded every 8 weeks regularly during the treatment through study completion, up to 36 months.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Peritoneal Cancer Index (PCI)
大体时间：At baseline and every 8 weeks fixed assessment time points during treatment by scheduled MDT assessment through study completion, up to 36 months.
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PCI score reflecting peritoneal tumor burden is measured on FAPI PET/CT images to observe tumor load variations.
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At baseline and every 8 weeks fixed assessment time points during treatment by scheduled MDT assessment through study completion, up to 36 months.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2030年8月1日
研究完成 (估计的)
2031年3月1日
研究注册日期
首次提交
2026年9月1日
首先提交符合 QC 标准的
2026年9月8日
首次发布 (实际的)
2026年9月11日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月8日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.