Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study (PICM)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The objective is to evaluate whether the neoadjuvant combination of tislelizumab (a PD-1 inhibitor) with interleukin-2 (IL-2) chemotherapy can significantly increase the Objective Response Rate (ORR) and the Pathological Complete Response rate (pCR) in patients with locally advanced rectal cancer who have Microsatellite Stable/Proficient Mismatch Repair (MSS/pMMR) status.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Males and females aged between 18 and 75 years;
• An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Histologically confirmed rectal adenocarcinoma;
• Clinical stage T3-T4 or any T with node-positive (N+) disease: locally advanced;
• Microsatellite stable (MSS) status;
• Adequate hematological, hepatic, and renal functions.
Locations
Other Locations
China
Jiangsu province hospital
RECRUITING
Nanjing
Nanjing BenQ Hospital
RECRUITING
Nanjing
Xuzhou Central hospital
RECRUITING
Xuzhou
The Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Contact Information
Primary
Yueming Sun
sunyueming@njmu.edu.cn
862568306026
Backup
Yue Wang
wangyue@126.com
862568306026
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2027-07-10
Participants
Target number of participants: 130
Treatments
Active_comparator: Conventional Neoadjuvant Group
Radiotherapy 1.8Gy per time\*28 And Capecitabine: 825mg/m2 bid po, a total of 28 days CapeOX 2 cycles (Capecitabine: 825mg/m2 bid po, d1-d14；Oxaliplatin 200 mg/m² ivd, d1
Experimental: PD-1+IL-2+CapeOX group
Tislelizumab 200mg ivd D1+Interleukin 2 100IU HD, d1-d14+ CapeOX (total 6 cycles)
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University