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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Feb 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced colon cancer that has spread to the lining of the abdomen, known as peritoneal metastasis. The researchers want to find out if combining a drug called serplulimab with a standard chemotherapy regimen (FOLFIRI) and another medication (bevacizumab) is effective and safe for patients whose cancer has specific genetic characteristics.

To participate in this trial, patients should be between the ages of 18 and 75 and must have a confirmed diagnosis of colon cancer that cannot be surgically removed. They should also have certain blood test results within a healthy range and be able to tolerate the treatment, which may include immunotherapy and chemotherapy. Participants will receive the study treatment and will be closely monitored by the medical team throughout the trial. This study is currently looking for volunteers, and all participants will need to give their informed consent before starting any trial procedures.

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Eligibility 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 \</= 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