RecruitingPhase 3NCT05752136

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma: a Prospective, Multicenter, Randomized Controlled Study (PRECAM-R)


Sponsor

Sir Run Run Shaw Hospital

Enrollment

108 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer.In view of the shortcomings of the current preoperative neoadjuvant treatment model for locally advanced rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 2 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a short course of radiation followed by immunotherapy (envafolimab) and chemotherapy (CAPEOX) before surgery improves outcomes for people with locally advanced rectal cancer that is classified as microsatellite stable (MSS) — a subtype that typically does not respond well to immunotherapy alone. **You may be eligible if...** - You are 18 or older with locally advanced rectal cancer (tumor within 12 cm of the anal opening) - Your cancer has been confirmed as rectal adenocarcinoma by biopsy - Your cancer is MSS or pMMR (a test result showing the cancer is less likely to respond to standard immunotherapy) - You have not previously received any cancer treatment - Your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (Stage IV) - Your cancer is MSI-H or dMMR (a different molecular subtype) - You have had prior cancer treatment - You have allergies to oxaliplatin, capecitabine, or PD-L1 antibody drugs - You have intestinal obstruction, perforation, or bleeding requiring emergency surgery 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALEnvafolimab

This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW).


Locations(1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05752136


Related Trials