PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for RAS-mut MSS mCRC

Trial Title: PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for RAS-mut MSS mCRC

NCT ID: NCT06206096

Condition: Colorectal Cancer
RAS Mutation
Colorectal Neoplasms
Microsatellite Stable Colorectal Carcinoma

Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Capecitabine
Oxaliplatin
Antibodies

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: oxaliplatin+capecitabine+bevacizumab+PD-1 antibody
Description: oxaliplatin will be administered once every 3 weeks at a dose of 130 mg/m2; Capecitabine will be taken orally at a dose of 1g/m2 twice daily for continuous oral administration over 14 days; Bevacizumab will be administered intravenously every 3 weeks at a dose of 7.5 mg/kg; PD-1 antibody was given due to different types.
Arm group label: CAPOX+BEV+PD-1

Summary: This study is designed to explore the efficacy and safety of anti-PD-1 antibody plus bevacizumab and chemotherapy as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically or cytologically confirmed non resectable, locally advanced or metastatic colorectal cancer; - No previous anti-tumor treatment for metastatic diseases; - KRAS/NRAS mutation; - Eastern Cooperation Oncology Group (ECOG) performance status of 0-1; - Life expectancy ≥ 3 months; - Adequate organ and bone marrow functions: Absolute neutrophil count≥1.5x10^9/L; Platelet count≥100x10^9/L; Hemoglobin≥9g/dL; Serum bilirubin<1.5x the upper limit of normal(ULN); Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)<1.5x ULN; Serum creatinine<1.5x ULN; Endogenous creatinine clearance rate ≥ 50ml / min; - Women of childbearing age need to take effective contraceptive measures. Exclusion Criteria: - Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors; - With BRAF mutation or MSI-H status; - Other untreated or concurrent tumors (except cervical carcinoma in situ, treated basal cell carcinoma or superficial bladder tumor, or if the tumor is cured and there is no evidence of disease for more than 3 years); - Have received other systemic anti-tumor treatments, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy within 4 weeks before enrollment; - There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment; - Have received any surgery or invasive treatment or operation within 4 weeks before enrollment; - Have received Local anti-tumor therapy such as hepatic artery interventional embolization, liver metastasis cryoablation or radiofrequency ablation within 4 weeks before enrollment; - Uncontrolled malignant ascites; - Participated in other clinical trials within 4 weeks before enrollment, and received corresponding experimental drug treatment; - Allergic to the study drug or any of its adjuvants; - International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN； - The researchers judged clinically significant electrolyte abnormalities; - Hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg; Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment); - Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases; - Any disease or state affecting drug absorption before enrollment, or the patient cannot take oral medication; - Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months; - Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%; - Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）; - History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10^4/ml or >2000 IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×10^3/m); hepatitis and cirrhosis; - Women who are pregnant or lactating; - Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g; - Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not suitable for enrolling according to the judgment of the investigator.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Chinese PLA General Hospital

Address:
City: Beijing
Zip: 100853
Country: China

Status: Recruiting

Contact:
Last name: Guanghai Dai, PhD

Phone: 13801232381
Email: daigh301@vip.sina.com

Start date: May 26, 2021

Completion date: December 2025

Lead sponsor:
Agency: Chinese PLA General Hospital
Agency class: Other

Source: Chinese PLA General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06206096