NCT05998122View on ClinicalTrials.gov

Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Locally Advanced Rectal CancerTotal Neoadjuvant TreatmentAnti-PD-1
Interventions
OTHER

nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W

"Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w).~Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1).~Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient."

Trial Locations (1)

Unknown

First Hospital of Jilin University, Changchun

All Listed Sponsors
lead

The First Hospital of Jilin University

OTHER

NCT05998122 - Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study | Biotech Hunter | Biotech Hunter