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Recruiting NCT05742425

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

Phase II Interventional Unresectable Colon Cancer Peritoneal Metastases PMMR/Ras/BRAF Wild-type

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serplulimab Combined With FOLFIRI and Bevacizumab.
Who it may be relevant to
Registry conditions: Unresectable Colon Cancer Peritoneal Metastases, PMMR/Ras/BRAF Wild-type. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Serplulimab Combined With FOLFIRI and Bevacizumab
    For patients with confirmed failure to reach CC0/1, they should be treated with sullizumab combined with FOLFIRI+bevacizumab for 4-8 cycles within 3 weeks after the exploration operation. After the end of the 4th and 8th cycles, they should be evaluated with imaging and MDT. If the conversion is successful, they should be treated with a second exploration operation within 3-4 weeks, The patients with CC0/1 can be evaluated for tumor reduction surgery (CRS) combined with intraperitoneal hyperther

Primary outcome measures

  • Disease-free survival (DFS) [Time frame: 3 years]
Secondary outcome measures (4)
  • Objective Remission Rate (ORR) [Time frame: 3 months after preoperative chemotherapy]
  • 3-year overall survival (OS) [Time frame: 3 years]
  • CC0/1 resection rate [Time frame: during operation]
  • Incidence rate of adverse events [Time frame: Baseline before any treatment,3 months after any treatment]

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:
  • Age between 18 and 75 years
  • Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Changxing County People's Hospital — Huzhou

Identifiers

NCT: NCT05742425 · 2022-1000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗