RecruitingPhase 2Phase 3NCT04547166

A Clinical Study to Evaluate Efficacy and Safety of Serplulimab(HLX10) Combined With Bevacizumab(HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)

A Randomized, Double-blind, Multicenter, PhaseⅡ/Ⅲ Clinical Study of Serplulimab in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)


Sponsor

Shanghai Henlius Biotech

Enrollment

568 participants

Start Date

Mar 10, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (serplulimab, which blocks a protein that prevents the immune system from attacking tumors) and an anti-blood vessel drug (bevacizumab) to standard XELOX chemotherapy improves outcomes in patients with metastatic colorectal cancer who have not yet been treated. **You may be eligible if...** - You have been confirmed to have unresectable (cannot be surgically removed) metastatic colorectal cancer - You have NOT received prior chemotherapy for your metastatic disease - If you received prior adjuvant (post-surgery) chemotherapy, it was completed more than 12 months ago - You have at least one measurable tumor on scans - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have previously received systemic chemotherapy for metastatic disease - You have active autoimmune disease or are on chronic steroids - You have had a serious bowel perforation or uncontrolled bleeding - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX10

a single fixed dose of 300 mg, intravenous infusion (IV), every 3 weeks (Day 1 of each cycle \[D1\]), non-reducible.

DRUGHLX04、

7.5mg/kg, IV, every 3 weeks (D1 of each cycle), non-reducible.


Locations(5)

Center for Cancer Prevention and Treatment of Sun Yat-sen University

Guangzhou, Guangdong, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Linyi Cancer Hospital

Linyi, China

Fudan University Affiliated Oncology Hospital

Shanghai, China

National Cancer Center

Kashiwa, Japan

View Full Details on ClinicalTrials.gov

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NCT04547166


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