NCT04856787

A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Study of SHR-1701 or Placebo in Combination With BP102 (Biosimilar to Bevacizumab) and XELOX in First-line Treatment of mCRC

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to bevacizumab) and XELOX in first-line treatment of patients with mCRC.

Conditions

• Metastatic Colorectal Cancer (mCRC)

Interventions

Type	Name	Description
DRUG	SHR-1701、 BP102 、XELOX	Phase 2：Single Group Drug:SHR-1701 30mg/kg，IV ,every 3 week Drug：BP102 7.5mg/kg，IV,every 3 week Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
DRUG	SHR-1701、 BP102 、XELOX	Phase 3：Randomized Drug:SHR-1701 30mg/kg，IV ,every 3 week Drug：BP102 7.5mg/kg，IV,every 3 week Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
DRUG	placebo、 BP102、 XELOX	Phase 3：Randomized Drug:Placebo 30mg/kg，IV ,every 3 week Drug：BP102 7.5mg/kg，IV,every 3 week Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days

Timeline

• Start date: 2021-06-22
• Primary completion: 2024-04-17
• Completion: 2024-04-17
• First posted: 2021-04-23
• Last updated: 2025-05-18

Locations

1 site across 1 country: China