RecruitingPhase 2NCT07198165

SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC

Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Sponsor

Ruijin Hospital

Enrollment

104 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer Rectal Adenocarcinoma Targeted Therapy Immunotherapy Chemoradiotherapy Rectal Cancer Patients Rectal Cancer, Radiotherapy Total Neoadjuvant Therapy Total Neoadjuvant Treatment

Summary

This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for locally advanced rectal cancer that uses short-course radiation therapy followed by chemotherapy (CAPOX + bevacizumab) and possibly an immune checkpoint drug (a PD-1 inhibitor). The goal is to shrink the tumor before surgery and improve outcomes. **You may be eligible if...** - You have been confirmed to have rectal cancer (adenocarcinoma) that has not yet been treated - Your cancer is locally advanced (has grown into nearby tissue or lymph nodes) based on MRI - You are 18–75 years old and in reasonably good health - You do not have cancer that has spread to distant organs **You may NOT be eligible if...** - Your tumor has a BRAF mutation or is MSI-high (certain genetic features that change treatment response) - You have severe bowel obstruction - You have already received treatment for this cancer 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

DRUGPD-1 inhibitor based immunotherapy

Short-course radiotherapy (25Gy/5Fx) followed by 4 cycles of CAPOX regimen (Oxaliplatin 130mg/m² IV infusion, Capecitabine 1000mg/m² orally for 14 days, Q3w) combined with Bevacizumab (7.5mg/kg IV infusion, D1, Q3w) + PD-1 inhibitor (Toripalimab 240mg IV infusion, D1, Q3w).

Locations(1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT07198165

Related Trials

Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial

NCT068500901 location

Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy

NCT075610601 location

Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer

NCT075282091 location

A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

NCT06997497161 locations

Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.

NCT069116841 location