Efficacy and Safety of Combined With Immunotherapy After Induction Therapy With Chemotherapy and Targeted Therapy in the First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer

NCT06176885 | Recruiting Phase 2

• 1 other identifier: 321000
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Colorectal Cancer

Keywords

colorectal cancer; Hepatopulmonary metastasis; Camrelizumab; MSS; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• PFS（Disease-free Survival）

  Disease-free Survival

  11.5 months

Secondary Outcomes (5)

• ORR（Objective Remission Rate）

  2 years

• Conversion resection rate

  2 years

• OS（Overall Survival）

  more than 2 years

• Incidence of Treatment-Emergent Adverse Events

  2 years

• DCR（Disease control rate）

  2 years

Study Arms (1)

Camrelizumab Group

EXPERIMENTAL

Combined with Camrelizumab after irinotecan leucovorin and fluorouracil (FOLFIRI) chemotherapy and bevacizumab targeted induction therapy

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

Combination therapy with Camrelizumab monoclonal antibody will be administered after the initial two cycles of induction therapy.

Camrelizumab 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:

• 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)

You may not qualify if:

• 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)
• The patient had obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding \> 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood \> 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) may be required
• At the time of screening, tumors were found to invade large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, which were judged by the investigator to have a high risk of bleeding
• "Active heart disease, including myocardial infarction, severe/unstable angina, occurred 6 months before treatment." Echocardiography showed that the left ventricular ejection fraction was less than 50% and the arrhythmia was not well controlled
• Patients with other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years or at the same time
• Known allergy to the study drug or any of its excipients

Sponsors & Collaborators

• yue junhan: lead

Study Sites (1)

Department of Colorectal Surgery, Affiliated Jinhua Hosptial, Zhejiang University

Jinhua, Zhejiang, 321000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

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

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: December 20, 2023
• Study Start: December 20, 2023
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 20, 2026
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (1)