Combining serplulimab with chemotherapy for treating colon cancer spread to the abdomen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating a new treatment for metastatic colorectal cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.