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

NCT06206096 | Recruiting Phase 2

• 1 other identifier: ZLNK-CRC-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; RAS Mutation; Colorectal Neoplasms; Microsatellite Stable Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  The proportion of patients with a confirmed complete response or partial response

  up to 3 years

Secondary Outcomes (4)

• PFS

  up to 3 years

• OS

  up to 3 years

• DCR

  up to 3 years

• Safety and tolerability by incidence, severity and outcome of adverse events

  up to 3 years

Study Arms (1)

CAPOX+BEV+PD-1

EXPERIMENTAL

Drug: oxaliplatin+capecitabine+bevacizumab+PD-1 antibody

Interventions

oxaliplatin+capecitabine+bevacizumab+PD-1 antibody DRUG

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.

CAPOX+BEV+PD-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Related Publications (1)

• Wang Y, Jia R, Si H, Ma Y, Fan M, Zhang N, Liu F, Shi Y, Jia Y, Zhang Y, Han Q, Wang Z, Dai G. Efficacy and safety of sintilimab plus bevacizumab and CAPOX as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer. BMC Cancer. 2025 Mar 7;25(1):422. doi: 10.1186/s12885-025-13794-w.

  PMID: 40055652 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

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 Officials

• Guanghai Dai, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru Jia, MD

CONTACT

+8613811721720; ashleyjr@163.com

Study Design

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

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: May 26, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)