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A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

NCT05652894 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-05-14

No results posted yet for this study

Summary

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), achieved by HX008 or Investigator's Choice Chemotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC).

Conditions

Interventions

DRUG

HX008(Pucotenlimab)

Drug: HX008(Pucotenlimab) 200 mg ,Q3W

DRUG

Investigator's Choice Chemotherapy

Drug: bevacizumab 5mg/kg given by IV every 14 days. Other Name: Avastin Drug: cetuximab 400 mg/m2 for the first dose, then 250 mg/sqm, intravenous infusion, repeated weekly; or Cetuximab 500 mg/ sqm, intravenous infusion, D1, repeated every 2 weeks. Other Name: Erbitux Drug: oxaliplatin 85 mg/sqm by IV, day1. Component of mFOLFOX6. Drug: irinotecan 180 mg/sqm by IV, day1.Component of FOLFORI. Drug: calcium Folinate 400 mg/sqm by IV, day1.Component of mFOLFOX6 or FOLFORI. Drug: 5-fluorouracil 400 mg/sqm, day1,followed by 2400 mg/sqm iv infusion over 46\~48 h.Component of mFOLFOX6 or FOLFORI. Drug: oxaliplatin 130 mg/sqm, intravenous infusion over 2 h ± 30 min, Day 1. Component of CAPEOX. Drug: capecitabine 1000 mg/sqm administered orally twice daily, Days 1-14. Component of CAPEOX. Drug: bevacizumab 7.5 mg/kg, intravenous infusion, D1, repeated every 3 weeks

Sponsors & Collaborators

  • Taizhou Hanzhong biomedical co. LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2026-06-30
Completion
2028-10-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652894 on ClinicalTrials.gov