Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases

• Status: Recruiting
• Trial end date: 2028-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicentric randomised trial. The goal of this clinical research study is to evaluate the efficacy and safety of serplulimab combined with FOLFIRI+bevacizumab in the treatment of pMMR/Ras/BRAF wild-type unresectable peritoneal metastasis of colon cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborator: Changxing People's Hospital
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 1. Colon cancer was confirmed by histology, and its gene detection was pMMR/MSS and RAS/BRAF wild-type. Imaging showed peritoneal metastasis.

• 2. Peritoneal metastatic carcinoma that could not reach CC0/1 was detected surgically.

• 3. Patients with the following general characteristics:

1. Age between 18 and 75 years

2. Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks

3. Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine

• 4. Hepatic function: AST (SGOT)/ALT (SGPT)Normal) ULN.

• 5. Able to tolerate immunotherapy, chemotherapy and surgery.

• 6. Patients will be informed and a signed consent before initiating any procedure specific to the trial.

Exclusion Criteria:

• 1. Age >75years or age<18years.

• 2. Cancers of non colonic origin.

• 3. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years.

• 4. Known HIV, Hepatitis B or Hepatitis C positive.

• 5. Pregnant women or likely to be pregnant.

• 6. Persons under guardianship.

• 7. Subjects deemed unable to comply with study and/or follow-up procedures.

• 8. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity