NCT05742425 Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
| NCT ID | NCT05742425 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Unresectable Colon Cancer Peritoneal Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-03 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-03 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Lifeng Sun
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT05742425 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Unresectable Colon Cancer Peritoneal Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05742425 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05742425 currently recruiting?
Yes, NCT05742425 is actively recruiting participants. Contact the research team at sunlifeng@zju.edu.cn for enrollment information.
Where is the NCT05742425 trial being conducted?
This trial is being conducted at Huzhou, China.
Who is sponsoring the NCT05742425 clinical trial?
NCT05742425 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Lifeng Sun at Zhejiang University. The trial plans to enroll 30 participants.
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