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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)

Study acronym: STAR
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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 Number NCT07669220
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators: Junshi Biosciences
Conditions
(from sponsor)		 Rectal Adenocarcinoma, High-risk Locally Advanced, Short-course Radiotherapy (SCRT), Immunotherapy, FOLFOX
Related terms Rectal Neoplasms
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov