RecruitingNCT06613165

Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer

Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer: a Prospective，Multicentre, Single-arm Study

Sponsor

Xijing Hospital

Enrollment

100 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Neoadjuvant Therapy dMMR Colorectal Cancer Immune-related Adverse Event

Summary

This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR/MSI-H rectal cancer. Participants will receive preoperative monotherapy with PD-1 antibodies, with regular reassessments every 2 cycles. Surgical intervention will be performed if clinical complete response (cCR) is achieved. Researchers will compare the pathological complete response rates, adverse reactions, and three-year event-free survival rates across different treatment cycles.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study explores how long immunotherapy (PD-1 inhibitors) should be given before surgery in people with stage II–III rectal cancer that has a specific genetic feature called dMMR or MSI-H, which makes it more likely to respond to immunotherapy. Finding the right treatment length could improve outcomes while reducing unnecessary side effects. **You may be eligible if...** - You are between 18 and 80 years old - You have rectal cancer confirmed as dMMR/MSI-H (a genetic marker your doctor can test for) - Your cancer is stage II or III (locally advanced, not yet spread to distant organs) - You have not received any prior treatment for this cancer **You may NOT be eligible if...** - You have already had chemotherapy, radiation, or immunotherapy - You have a serious autoimmune disease - You have significant heart, liver, or kidney issues - You are pregnant or breastfeeding 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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