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

NCT05742425 | Recruiting Phase 2

• 1 other identifier: 2022-1000
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable Colon Cancer Peritoneal Metastases; PMMR/Ras/BRAF Wild-type

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  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 Outcomes (4)

• Objective Remission Rate (ORR)

  3 months after preoperative chemotherapy

• 3-year overall survival (OS)

  3 years

• CC0/1 resection rate

  during operation

• Incidence rate of adverse events

  Baseline before any treatment,3 months after any treatment

Study Arms (1)

One-arm research group

EXPERIMENTAL

Drug: Serplulimab Combined With FOLFIRI and Bevacizumab

Interventions

Serplulimab Combined With FOLFIRI and Bevacizumab DRUG

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.

One-arm research group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Colon cancer was confirmed by histology, and its gene detection was pMMR/MSS and RAS/BRAF wild-type. Imaging showed peritoneal metastasis.
• \. Peritoneal metastatic carcinoma that could not reach CC0/1 was detected surgically.
• \. 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
• \. Hepatic function: AST (SGOT)/ALT (SGPT) \</= 5 X institutional (Upper Limit of Normal) ULN.
• \. Able to tolerate immunotherapy, chemotherapy and surgery.
• \. Patients will be informed and a signed consent before initiating any procedure specific to the trial.

You may not qualify if:

• \. Age \>75years or age\<18years.
• \. Cancers of non colonic origin.
• \. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years.
• \. Known HIV, Hepatitis B or Hepatitis C positive.
• \. Pregnant women or likely to be pregnant.
• \. Persons under guardianship.
• \. Subjects deemed unable to comply with study and/or follow-up procedures.
• \. 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Changxing People's Hospital: collaborator

Study Sites (1)

Changxing County People's Hospital

Huzhou, Zhejiang, 330522, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lifeng Sun

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lifeng Sun

CONTACT

+86-0571-87783777; sunlifeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 24, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)