Clinical trial · Interventional
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
NCT05742425CI-TRIAL-00064222recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PMMR/Ras/BRAF Wild-type | — | UNRESOLVED | — |
| Unresectable Colon Cancer Peritoneal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serplulimab Combined With FOLFIRI and Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- One-arm research group
- interventionNames
- Drug: Serplulimab Combined With FOLFIRI and Bevacizumab
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
- 3 years
- description
- 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 outcomes (4)
- measure
- Objective Remission Rate (ORR)
- timeFrame
- 3 months after preoperative chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.