Combining serplulimab with chemotherapy for treating colon cancer spread to the abdomen
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
This study is testing if adding serplulimab to chemotherapy can help people with colon cancer that has spread to the abdomen feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, serplulimab, bevacizumab |
| Locations | 1 site (Huzhou, Zhejiang) |
| Trial ID | NCT05742425 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of serplulimab when combined with the chemotherapy regimen FOLFIRI and the drug bevacizumab in patients with unresectable colon cancer that has spread to the peritoneum. The study is multicentric and randomized, focusing on patients with specific genetic markers (pMMR/Ras/BRAF wild-type). Participants will undergo treatment and be monitored for outcomes related to their cancer progression and overall health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with unresectable colon cancer peritoneal metastases and specific genetic profiles.
Not a fit: Patients over 75 years old or those with cancers originating from non-colonic sources may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a new effective option for patients with advanced colon cancer that is difficult to treat.
How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy with chemotherapy have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Huzhou, Zhejiang
- Changxing County People's Hospital — Huzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Lifeng Sun — Zhejiang University
- Study coordinator: Lifeng Sun
- Email: sunlifeng@zju.edu.cn
- Phone: +86-0571-87783777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.