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Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Summary
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are: Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime? Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs. Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.
Official title: Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Newly Diagnosed Non-metastatic Rectal Squamous Cell Carcinoma: A Multicenter, Prospective, Single Arm, Phase II Study(RICH).
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-04-12
Completion Date
2027-02-28
Last Updated
2025-11-24
Healthy Volunteers
No
Conditions
Interventions
PD-1 and CRT
Chemotherapy (/4W): a)DDP 75 mg/m2, d1, intravenous infusion; b)5-FU 1000 mg/m2, d1-4, continuous pumping intravenously; Immunotherapy (/4W): PD-1 monoclonal antibody(sintlimab) 200mg, d1, intravenous infusion; Radiotherapy (at 2rd week after firstime of chemotherapy):Daily single dose of 2Gy, with a total dose of 50-54Gy(clinical I-II stage)/54-59Gy(clinical III stage).
Locations (1)
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China