A Phase Ib/III, Open-Label, Randomized Study of Neoadjuvant QL1706 Versus Standard of Care in Participants With Untreated of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Signed written informed consent;
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Untreated pathologically confirmed colon adenocarcinoma
• Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
• Has a tumor demonstrating the presence of MSI-H/ dMMR
• Adequate organ function as described in the protocol
Locations
Other Locations
China
Affiliated Cancer Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Ruihua Xu, PhD
xurh@sysucc.org.cn
+086-020-87343468
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2030-12
Participants
Target number of participants: 363
Treatments
Experimental: Experimental group
Phase Ib/Ⅲ Participants will receive QL1706 pre surgery
Active_comparator: Phase III Control group
Participants will receive SOC (CAPEOX/Capecitabine) or undergo expectant observation post surgery.
Related Therapeutic Areas
Sponsors
Leads: Qilu Pharmaceutical Co., Ltd.