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

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.

Eligibility

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 \</= 1.5 mg/dL
* 4\. Hepatic function: AST (SGOT)/ALT (SGPT) \</= 5 X institutional (Upper Limit of 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

Conditions3

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