Trial intelligence / Profile preview

Sintilimab in locally advanced rectal cancer

NCT05450029Phase 2

Key facts

Status: Recruiting
Start: Jan 2022
Primary completion: Jan 2024
Countries: 1
Sponsor: Yanhong Deng
Modality: Monoclonal Antibodies

Drugs: sintilimab
Conditions: rectal cancer

Overview

Phase 2, open-label, single-arm trial of sintilimab in rectal cancer, sponsored by Yanhong Deng. Primary endpoint: Pathological complete response. Started Jan 2022; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Experimental Arm
Neoadjuvant mFOLFOX6 followed by chemoradiotherapy with Sintilimab, then surgery.

Who it enrols

Treatment-naive adults (18-75 years) with locally advanced rectal adenocarcinoma (cT3/T4 or N positive, M0) and an intermediate or high Immunoscore, with an ECOG performance status of 0 or 1 and adequate organ function.

Endpoints

Primary

Pathological complete response1 month after surgery

Secondary

Margin-free (R0) resection rateImmediately after the surgery
3-year event-free survival rate3 years after the surgery
3-year overall survival rate3 years after the surgery
Local recurrence3 years after the surgery
Tumor downstagingduring the 3-year period of follow-up
Tumor regression gradeduring the 3-year period of follow-up
Number of participants with surgical complications30 days after surgery
Correlation between minimal residual disease (MRD) and survival3 years after the surgery

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