MA-CRC-II-016 SHR-1811

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07355764
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Antibody-drug Conjugates
  • HER2
  • Targeted Therapy
  • mCRC

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

A randomized, controlled, multicenter clinical study of SHR-A1811 combined with bevacizumab for the second-line treatment of metastatic colorectal cancer

Key Dates

First listed
Jan 21, 2026
Start date
Dec 30, 2025
Status verified
Jan 2026
Primary completion
Jan 30, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SHR-A1811 combined with bevacizumab
    SHR-A1811 with bevacizumab
  • Active Comparator: Chemotherapeutic Combinations
    chemotherapy with bevacizumab

Primary Outcome Measure

ORR [ Time Frame: The end of cycle 2 (each cycle is 21 days) for SHR-A1811+BEV group and the end of cycle 3 (each cycle is 14 days) for FOLFIRI+BEV group ]

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