Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05742425

Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-02-24

30

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

C

Changxing People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Colon cancer confirmed by histology with pMMR/MSS and RAS/BRAF wild-type gene status
  • Imaging shows peritoneal metastasis
  • Peritoneal metastatic carcinoma not able to reach CC0/1 by surgery
  • Age between 18 and 75 years
  • Performance status (ECOG) 0, 1, or 2 with life expectancy over 12 weeks
  • Adequate kidney and bone marrow function: leukocytes  3,000/microL; absolute neutrophil count  1,500/microL; platelets  100,000/Ul; serum creatinine  1.5 mg/dL
  • Liver function with AST/ALT  5 times upper normal limit
  • Able to tolerate immunotherapy, chemotherapy, and surgery
  • Informed consent signed before any trial procedures
Not Eligible

You will not qualify if you...

  • Age younger than 18 years or older than 75 years
  • Cancer originating outside the colon
  • History of cancer (other than certain skin or cervical cancers) with recurrence within the past 5 years
  • Known positive for HIV, Hepatitis B, or Hepatitis C
  • Pregnant or likely to become pregnant
  • Under legal guardianship
  • Unable to follow study or follow-up procedures
  • Known life-threatening or severe allergic reaction to the chemotherapy used in this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Changxing County People's Hospital

Huzhou, Zhejiang, China, 330522

Actively Recruiting

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Research Team

L

Lifeng Sun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases | DecenTrialz