Status: Recruiting
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.
Participants needed: 76
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Sixth Affiliated Hospital, Sun Yat-sen UniversityUpdated: Jun 25, 2026Locations: 1
Eligibility criteria
Before implementing any procedures related to the study protocol rather than rou... [+10]
Patients with a history of severe drug allergy (including allergy to platinum ag... [+16]