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

February 14, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Huzhou, Zhejiang, China, 330522
        • Recruiting
        • Changxing County People's Hospital
        • Contact:
          • Hongwei Wu
          • Phone Number: +86-0572-6023641

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One-arm research group
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 hyperthermic perfusion chemotherapy (HIPEC), and the follow-up treatment plan will be selected according to the clinical situation of the patients after surgery; If CC0/1 cannot be evaluated after the second exploration surgery and CC0/1 cannot be performed after the imaging evaluation, other chemotherapy and optimal supportive treatment will be performed according to the situation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: 3 years
The period from the beginning of treatment to the first occurrence of disease progression or death from any cause. If such situation is not met, the last evaluation date shall be used for analysis. In addition, if the treatment is terminated without confirming the progress of the disease, the imaging examination and follow-up should also be carried out after the treatment is terminated.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Remission Rate (ORR)
Time Frame: 3 months after preoperative chemotherapy
The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The remission period usually refers to the period from the beginning of curative effect to the confirmation of tumor progression. The objective response rate is generally defined as the sum of complete response plus partial response (CR+PR).
3 months after preoperative chemotherapy
3-year overall survival (OS)
Time Frame: 3 years
The time from the date of treatment to the date of death due to any reason. For patients who survived in the final analysis, the date of the last contact will be recorded.
3 years
CC0/1 resection rate
Time Frame: during operation
Complete tumor reduction surgery: CC-0: no peritoneal residual tumor; CC-1: residual tumor diameter<2.5mm.
during operation
Incidence rate of adverse events
Time Frame: Baseline before any treatment,3 months after any treatment
According to NCI CTCAE v5.0
Baseline before any treatment,3 months after any treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Changxing People's Hospital

Investigators

  • Principal Investigator: Lifeng Sun, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2028

Study Completion (Anticipated)

March 1, 2028

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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