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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Subjects voluntarily enroll in the study, sign informed consent, demonstrate good compliance and cooperate with follow-up visits.

Aged between 18 and 75 years inclusive, male or female.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Estimated survival expectancy ≥ 12 weeks.

Disqualifiers

Received systemic anti-tumor therapies (including investigational agents) or major surgery within 4 weeks prior to the first study drug administration; palliative radiotherapy within 2 weeks or surgery within 4 weeks before study treatment initiation.

History of hypersensitivity to monoclonal antibodies or any component of the investigational products to be administered in this study.

Pre-existing peripheral neuropathy of Grade >1.

History of thromboembolic disease within 6 months or hemoptysis within 3 months before first study medication. Subjects with muscular venous thrombosis not requiring anticoagulation per investigator's assessment are eligible for enrollment.

Trial design

Treatments tested in this trial

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

Treatment groups

300 Participants
are divided into 2 treatment groups