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

Zhejiang University

Status and phase: Enrolling; Phase 2

Conditions: PMMR/Ras/BRAF Wild-type; Unresectable Colon Cancer Peritoneal Metastases

Treatments: Drug: Serplulimab Combined With FOLFIRI and Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05742425

2022-1000

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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:

  4. Age between 18 and 75 years

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

  6. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

One-arm research group

Experimental group

Treatment:

Drug: Serplulimab Combined With FOLFIRI and Bevacizumab