Back to resultsSerplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
Primary Purpose
Unresectable Colon Cancer Peritoneal Metastases, PMMR/Ras/BRAF Wild-type
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Serplulimab Combined With FOLFIRI and Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Colon Cancer Peritoneal Metastases
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
Sites / Locations
- Changxing County People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One-arm research group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective Remission Rate (ORR)
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-year overall survival (OS)
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.
CC0/1 resection rate
Complete tumor reduction surgery: CC-0: no peritoneal residual tumor; CC-1: residual tumor diameter<2.5mm.
Incidence rate of adverse events
According to NCI CTCAE v5.0
Full Information
NCT ID
NCT05742425
First Posted
February 5, 2023
Last Updated
February 14, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Changxing People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05742425
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2028 (Anticipated)
Study Completion Date
March 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Changxing People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Colon Cancer Peritoneal Metastases, PMMR/Ras/BRAF Wild-type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One-arm research group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Serplulimab Combined With FOLFIRI and Bevacizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Objective Remission Rate (ORR)
Description
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).
Time Frame
3 months after preoperative chemotherapy
Title
3-year overall survival (OS)
Description
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.
Time Frame
3 years
Title
CC0/1 resection rate
Description
Complete tumor reduction surgery: CC-0: no peritoneal residual tumor; CC-1: residual tumor diameter<2.5mm.
Time Frame
during operation
Title
Incidence rate of adverse events
Description
According to NCI CTCAE v5.0
Time Frame
Baseline before any treatment,3 months after any treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lifeng Sun
Phone
+86-0571-87783777
Email
sunlifeng@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lifeng Sun
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changxing County People's Hospital
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
330522
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongwei Wu
Phone
+86-0572-6023641
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
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