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

NCT ID: NCT05742425

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2028-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One-arm research group

Group Type: EXPERIMENTAL

Serplulimab Combined With FOLFIRI and Bevacizumab

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changxing People's Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lifeng Sun

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

Changxing County People's Hospital

Huzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lifeng Sun

Role: CONTACT

sunlifeng@zju.edu.cn

+86-0571-87783777

Facility Contacts

Hongwei Wu

Role: primary

+86-0572-6023641

Other Identifiers

2022-1000

Identifier Type: -

Identifier Source: org_study_id