Trial intelligence / Profile preview

Sintilimab + Regorafenib + HAIC in CRLM

NCT05524155Phase 2

Key facts

Status: Unknown
Start: Sep 2022
Primary completion: Mar 2024
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Modality: Monoclonal Antibodies

Drugs: sintilimab
Conditions: colorectal cancer (CRC)

Overview

Phase 2, open-label, single-arm trial of sintilimab in colorectal cancer (CRC), sponsored by Tianjin Medical University Cancer Institute and Hospital. Primary endpoints: Adverse Events (AEs) up to 24 months and Overall Response Rate up to 24 months. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-label

Sintilimab + Regorafenib + HAIC
Sintilimab Combined With Regorafenib and HAIC

Who it enrols

Adult patients with unresectable metastatic colorectal cancer with liver metastases who have failed or are intolerant to second-line therapy, with ECOG PS 0-1 and adequate organ function.

Endpoints

Primary

Adverse Events (AEs)up to 24 months
Overall Response Rateup to 24 months

Secondary

Disease Control Rateup to 24 months
Duration of Responseup to 24 months
Progression Free Survivalup to 28 months
Overall Survivalup to 28 months

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