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

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety of Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of pMMR/Ras/BRAF Wild-type Unresectable Colon Cancer Peritoneal Metastases: a Multicenter Single-arm Phase II Trial

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

Intervention / Treatment
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* Drug: Serplulimab Combined With FOLFIRI and Bevacizumab


Participation Criteria
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Eligibility Criteria
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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: Age between 18 and 75 years Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-arm research group<br> | Drug: Serplulimab Combined With FOLFIRI and Bevacizumab<br>* For patients with confirmed failure to reach CC0/1, they should be treated with sullizumab combined with FOLFIRI+bevacizumab for 4-8 cycles within 3 weeks after the exploration operation. After the end of the 4th and 8th cycles, they should be evaluated with imaging and MDT. If the conversion is successful, they should be treated with a second exploration operation within 3-4 weeks, The patients with CC0/1 can be evaluated for tumor reduction surgery (CRS) combined with intraperitoneal hyperthermic perfusion chemotherapy (HIPEC), and the follow-up treatment plan will be selected according to the clinical situation of the patients after surgery; If CC0/1 cannot be evaluated after the second exploration surgery and CC0/1 cannot be performed after the imaging evaluation, other chemotherapy and optimal supportive treatment will be performed according to the situation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | The period from the beginning of treatment to the first occurrence of disease progression or death from any cause. If such situation is not met, the last evaluation date shall be used for analysis. In addition, if the treatment is terminated without confirming the progress of the disease, the imaging examination and follow-up should also be carried out after the treatment is terminated. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Remission Rate (ORR) | The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The remission period usually refers to the period from the beginning of curative effect to the confirmation of tumor progression. The objective response rate is generally defined as the sum of complete response plus partial response (CR+PR). | 3 months after preoperative chemotherapy | 
| 3-year overall survival (OS) | The time from the date of treatment to the date of death due to any reason. For patients who survived in the final analysis, the date of the last contact will be recorded. | 3 years | 
| CC0/1 resection rate | Complete tumor reduction surgery: CC-0: no peritoneal residual tumor; CC-1: residual tumor diameter<2.5mm. | during operation | 
| Incidence rate of adverse events | According to NCI CTCAE v5.0 | Baseline before any treatment,3 months after any treatment |