Clareo Health | FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)
FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)
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.
You may not be if
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.
