MedTrace Logo

Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

NCT06199973 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-07-17

No results posted yet for this study

Summary

The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects.

Conditions

  • Advanced Colorectal Cancer

Interventions

DRUG

SHR-A1811

SHR-A1811(4.8 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W)

DRUG

TAS-102, Regorafenib , Fruquintinib

physician choiced treatment,include: TAS-102(35 mg/m2, maximum 80 mg per dose), twice daily (BID) , once every 4 weeks (Q4W) , up to 3 years; or Regorafenib 160mg, once daily (QD) , once every 4 weeks (Q4W) , up to 3 years; or Fruquintinib 5mg once daily (QD) , once every 4 weeks (Q4W) , up to 3 years.

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
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT06199973 on ClinicalTrials.gov