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A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer

NCT07676162 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-06-30

No results posted yet for this study

Summary

This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.

Conditions

  • Advanced Colorectal Cancer

Interventions

DRUG

SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

SHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

DRUG

Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • China

Study Locations

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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 NCT07676162 on ClinicalTrials.gov