Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781413
Status:
UNKNOWN
Last Update Posted:
2021-03-04
First Post:
2021-02-28
Brief Title:
Nab-PTX Plus S-1 and Sintilimab as Adjuvant Therapy in Patients With Stage IIIC Gastric Cancer
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
A Phase III 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
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 33 design The regimen involves 3-week cycles with escalated doses of nab-paclitaxel 80-120 mgm2 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 40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None