A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)

This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR/MSS lower rectal adenocarcinoma, aiming to provide high-level evidence supporting a novel treatment paradigm.

Trial Details

NCT ID
NCT07669220
Phase
PHASE2
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Short-course Radiotherapy, SCRT
  • Toripalimab
Locations (sample)
  • Guangzhou, China|23.11667,113.25

Key Eligibility Criteria

  • Before implementing any procedures related to the study protocol rather than routine clinical care, a signed and dated informed consent form must b…
  • Age 18-75 years.
  • Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma.
  • The lower edge of the rectal tumor is located below the peritoneal reflection.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →