Efficacy and Safety of Camrelizumab Combined With Irinotecan, Leucovorin and Fluorouracil (FOLFIRI) Chemotherapy and Bevacizumab Targeted Induction Therapy in the First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer: a Prospective, Multicenter, Single-arm Study

yue junhan1 site in 1 country36 target enrollmentDecember 20, 2023

ConditionsColorectal Cancer

InterventionsCamrelizumab

DrugsCamrelizumab

Overview

Phase: Phase 2
Intervention: Camrelizumab
Conditions: Colorectal Cancer
Sponsor: yue junhan
Enrollment: 36
Locations: 1
Primary Endpoint: PFS（Disease-free Survival）
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to explore the feasibility of a new mode of chemotherapy and bevacizumab induction therapy combined with immunotherapy as first-line treatment for patients with initially unresectable metastatic colorectal cancer (MSS). The main questions it aims to answer are:

To explore the efficacy and safety of this treatment mode
Try to study treatment benefit the characteristics of the crowd Participants will combined with immunotherapy after chemotherapy and bevacizumab induction therapy.

Registry

clinicaltrials.gov

Start Date

December 20, 2023

End Date

December 20, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

yue junhan

Responsible Party

Sponsor Investigator

Principal Investigator

yue junhan

Director

Jinhua Central Hospital

Eligibility Criteria

Inclusion Criteria

•Patients voluntarily participated in the study signed the informed consent and had good compliance
•Body weight ≥40kg
•Metastatic colorectal cancer confirmed by histology and/or cytology and initially unresectable
•Microsatellite instable (MSS) or proficient Mismatch Repair (pMMR)
•Patients have at least one measurable lesion (RECIST 1.1)
•Eastern Cooperative Oncology Group Physical Status (ECOG PS) 0-1
•Expected survival ≥12 weeks
•Blood testing (not corrected with granulocyte colony-stimulating factor or other hematopoietic stimulating factor within 7 days prior to laboratory testing if not transfused within 14 days)
•Women of reproductive age had to have a serum pregnancy test with a negative result within 14 days before treatment and be willing to use a medically approved effective contraceptive during the study and for 3 months after the last dose of study medication
•Age 18-75 years old (including 18 and 75 years old)

Exclusion Criteria

•The patient had received radiation therapy surgery chemotherapy immune or molecular-targeted therapy or other investigational drugs within 4 weeks before treatment
•An active autoimmune disease requiring systemic therapy (i.e., disease-modifying medications, corticosteroids, or immunosuppressive agents) had occurred within the previous 2 years. Replacement therapies, such as thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency, are not considered systemic treatments
•Immunodeficiency was diagnosed within 7 days before the first treatment or received systemic steroid therapy or any other form of immunosuppressive therapy. Physiological doses of corticosteroids could be approved after consultation with the sponsor
•She had previously received anti-vascular small molecule targeted drug therapy, such as Fruquintinib
•Prior treatment with an irinotecan-based chemotherapy regimen
•Symptomatic brain or meningeal metastases
•Left colon cancer with wild-type rat sarcoma virus gene (RAS)
•MSI-H or dificient Mismatch Repair (dMMR) metastatic colorectal cancer
•Serious infection (e.g., intravenous antibiotic, antifungal, or antiviral) within 4 weeks before treatment, or unexplained fever \> 38.5 ° C during screening/first dose
•Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)