FAPI-guided radiotherapy with cadonilimab plus chemo for colorectal cancer limited to the peritoneum

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares a combined treatment (FAPI-guided radiotherapy, cadonilimab, and standard chemotherapy) against standard chemotherapy alone in adults whose colorectal cancer has spread only to the peritoneum. Participants are randomized to receive the new combination or standard chemo, with regular visits for infusions, imaging, and quality-of-life questionnaires. The study looks at tumor shrinkage, time to progression, safety, and overall outcomes. Eligibility requires confirmed colorectal adenocarcinoma with peritoneal confinement, measurable disease, and a positive FAPI PET/CT suitable for radiotherapy planning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histopathologically confirmed colorectal adenocarcinoma.
2. Tumors confirmed pMMR by immunohistochemistry or MSI-L/MSS via gene sequencing.
3. Metastases limited to peritoneum only, no metastases in other organs.
4. No moderate or massive ascites; only trivial physiological effusion without drainage requirement.
5. No symptomatic intestinal obstruction and no obstructive signs on imaging; patients can take food normally.
6. Baseline CT/MRI confirms peritoneal metastases.
7. Positive baseline FAPI PET/CT: at least one peritoneal mass lesion with long diameter ≥1 cm and markedly elevated SUVmax suitable for radiotherapy contouring.
8. At least one measurable lesion per RECIST v1.1 criteria.
9. Progression after first-line standard systemic therapy (FOLFOX/XELOX ± targeted agents); no prior second-line treatment received.
10. Peritoneal recurrence within 1 year after adjuvant fluoropyrimidine-based chemotherapy.
11. No moderate or massive ascites; only trivial physiological effusion without drainage requirement.
12. Voluntarily sign written informed consent and comply with scheduled study visits and treatment procedures.

Exclusion Criteria:

1. 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.
2. Moderate or massive ascites requiring clinical intervention.
3. Partial or complete symptomatic intestinal obstruction.
4. Pregnant or breastfeeding women.
5. History of high-dose abdominal radiotherapy that prevents re-irradiation.
6. Diffuse miliary peritoneal metastases on FAPI PET/CT without definable target volume for radiotherapy.
7. 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.
8. Poor compliance or other conditions judged inappropriate for study participation by investigators.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zhen Zhang, MD, PhD
• Email: zhen_zhang@fudan.edu.cn
• Phone: 18801735029

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.