RecruitingPhase 2NCT06364384

Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma

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).

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

20 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

Rectal Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining a PD-1 immunotherapy drug with a standard chemotherapy and radiation regimen (cisplatin plus 5-FU) for people with rectal squamous cell carcinoma (a rare type of rectal cancer) that has not spread to distant organs. **You may be eligible if...** - You have confirmed squamous cell carcinoma of the rectum - Your cancer has not spread to distant parts of the body - You are between 18 and 75 years old - Your blood counts and organ function are within acceptable ranges - Your overall performance status allows for treatment (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had previous radiation to the pelvis - Your blood counts, liver, or kidney function are too low for chemotherapy - You have serious heart conditions or other major health problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPD-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

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NCT06364384

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