Spots Global Cancer Trial Database for Nab-PTX Plus S-1 and Sintilimab as Adjuvant Therapy in Patients With Stage IIIC Gastric Cancer

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Trial Identification

Brief Title: Nab-PTX Plus S-1 and Sintilimab as Adjuvant Therapy in Patients With Stage IIIC Gastric Cancer

Official Title: A Phase I/II, Single-center, Single-arm, Open-label Study of Nanoparticle Albumin-bound-paclitaxel (Nab-PTX) Plus S-1 and Sintilimab as Adjuvant Therapy in Patients With Stage IIIC Gastric Cancer

Study ID: NCT04781413

Conditions

Stage IIIC Gastric Cancer

Interventions

Nab-PTX, Sintilimab, S-1

Study Description

Brief Summary: In this study, we combine Nab-PTX, S-1 and sintilimab as adjuvant regimen to patients with stage IIIC GC. We are aiming to investigate the recommended dose of this regimen in a phase I study and estimate the toxicity and efficacy of this regimen in a phase II study.

Detailed Description: The phase I study is a dose-escalation study using a standard 3+3 design. The regimen involves 3-week cycles with escalated doses of nab-paclitaxel (80-120 mg/m2 on days 1 and 8) and fixed doses of sintilimab (200 mg on day 1) and S-1 (based on body-surface area on day 1 to 14). The primary endpoints are safety and determination the recommended dose in the subsequent phase II study. In the phase II trial, the primary endpoint is 3-year relapse-free survival (RFS). Secondary endpoints are 5-year overall survival (OS), 3-year OS, 5-year RFS, and quality of life. Exploratory endpoint is time to peritoneal metastasis. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0.