Clinical trial NCT05742425: Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Unresectable Colon Cancer Peritoneal Metastases
PMMR/Ras/BRAF Wild-type
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Changxing People's Hospital
First posted: 2023-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 3 years
Secondary outcomes:
measure: Objective Remission Rate (ORR)
timeFrame: 3 months after preoperative chemotherapy
measure: 3-year overall survival (OS)
timeFrame: 3 years
measure: CC0/1 resection rate
timeFrame: during operation
measure: Incidence rate of adverse events
timeFrame: Baseline before any treatment,3 months after any treatment
Other outcomes:
Locations:
city: Huzhou
country: China
facility: Changxing County People's Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Lifeng Sun
role: PRINCIPAL_INVESTIGATOR
References: