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Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

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

Record History

  1. Study First Submitted
Xijing Hospital
179 trials monitored
See 8 trials at risk
Observation and evaluation of the safety and efficacy of PD-1 antibody combined with IBI310 and neoadjuvant chemotherapy in the treatment of locally advanced rectal cancer Primary objectives: Pathological complete response (pCR) rate; Secondary objectives: Treatment-related adverse events (CTCAE 5.0), clinical complete response (cCR) rate, major pathological response (MPR) rate, R0 resection rate, sphincter preservation rate, surgical complications, 3-year disease-free survival (DFS), and overall survival (OS);
Trial Details
NCT Number NCT07750951
Lead Sponsor Xijing Hospital
Conditions
(from sponsor)		 MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov