Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
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
Second Affiliated Hospital, School of Medicine, Zhejiang University
30 participants
Mar 1, 2023
INTERVENTIONAL
Conditions
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 Criteria9
- \. Colon cancer was confirmed by histology, and its gene detection was pMMR/MSS and RAS/BRAF wild-type. Imaging showed peritoneal metastasis.
- \. Peritoneal metastatic carcinoma that could not reach CC0/1 was detected surgically.
- \. 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
- \. Hepatic function: AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN.
- \. Able to tolerate immunotherapy, chemotherapy and surgery.
- \. Patients will be informed and a signed consent before initiating any procedure specific to the trial.
Exclusion Criteria8
- \. Age >75years or age<18years.
- \. Cancers of non colonic origin.
- \. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years.
- \. Known HIV, Hepatitis B or Hepatitis C positive.
- \. Pregnant women or likely to be pregnant.
- \. Persons under guardianship.
- \. Subjects deemed unable to comply with study and/or follow-up procedures.
- \. 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05742425