Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
- Conditions
- Unresectable Colon Cancer Peritoneal MetastasesPMMR/Ras/BRAF Wild-type
- Interventions
- Registration Number
- NCT05742425
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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- Colon cancer was confirmed by histology, and its gene detection was pMMR/MSS and RAS/BRAF wild-type. Imaging showed peritoneal metastasis.
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- Peritoneal metastatic carcinoma that could not reach CC0/1 was detected surgically.
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Patients with the following general characteristics:
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Age between 18 and 75 years
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Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
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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
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- Hepatic function: AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN.
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- Able to tolerate immunotherapy, chemotherapy and surgery.
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- Patients will be informed and a signed consent before initiating any procedure specific to the trial.
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- Age >75years or age<18years.
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- Cancers of non colonic origin.
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- History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years.
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- Known HIV, Hepatitis B or Hepatitis C positive.
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- Pregnant women or likely to be pregnant.
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- Persons under guardianship.
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- Subjects deemed unable to comply with study and/or follow-up procedures.
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- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description One-arm research group Serplulimab Combined With FOLFIRI and Bevacizumab -
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) 3 years 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.
- Secondary Outcome Measures
Name Time Method 3-year overall survival (OS) 3 years 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.
Objective Remission Rate (ORR) 3 months after preoperative chemotherapy 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).
CC0/1 resection rate during operation Complete tumor reduction surgery: CC-0: no peritoneal residual tumor; CC-1: residual tumor diameter\<2.5mm.
Incidence rate of adverse events Baseline before any treatment,3 months after any treatment According to NCI CTCAE v5.0
Trial Locations
- Locations (1)
Changxing County People's Hospital
🇨🇳Huzhou, Zhejiang, China