Trial intelligence / Profile preview

Sintilimab + Gem/Nab-P in Resectable/Borderline Resectable Pancreatic Cancer

NCT05562297Phase 2

Key facts

Status: Not yet recruiting
Start: Mar 2025
Primary completion: Oct 2027
Countries: 1
Sponsor: Zhongshan Hospital, Fudan University
Modality: Monoclonal Antibodies

Drugs: sintilimab
Conditions: pancreatic cancer (PC)

Overview

Phase 2, open-label, single-arm trial of sintilimab in pancreatic cancer (PC), sponsored by Zhongshan Hospital, Fudan University. Primary endpoint: 2-year Overall Survival. Planned start Mar 2025; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

sintilimab + nab-paclitaxel + gemcitabine
Sintilimab combined with nab-paclitaxel and gemcitabine

Who it enrols

Patients with resectable or borderline resectable pancreatic adenocarcinoma, ECOG 0-1, and adequate organ function. Excludes patients with prior anti-tumor treatment, tumors <= 2 cm, or serious comorbidities.

Endpoints

Primary

2-year Overall Survival2 years

Secondary

Overall Survivalup to 24 months
Event-Free Survivalup to 24 months
Objective Response Rateup to 24 months
Disease Control Rateup to 24 months
Recurrence-Free Survivalup to 24 months
Resection Rateup to 24 months
R0 Resection Rateup to 24 months
Major Pathological Response Rateup to 24 months

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