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
Sponsor study identifier
interventional
38
1 country
1
Study Start
March 1, 2021
Actual (reported)Primary Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2021
Actual (reported)March 1, 2021
Actual (reported)March 4, 2021
Actual (reported)March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
3-year relapse-free survival (RFS)
36 months
5-year overall survival (OS)
60 months
5-year relapse-free survival (RFS)
60 months
Adverse events
36 months
Peritoneal metastasis rate
36 months
The phase I trial is a dose escalation design with standard 3+3 followed by expansion cohorts. Level Nab-PTX S-1 Sintilimab 1. 80 mg/m2 80mg/m2 200mg 2. 100 mg/m2 80mg/m2 200mg 3. 120 mg/m2 80mg/m2 200mg We start at level 1. The recommended dose (RD) is defined as dose equal to the maximum tolerated dose (MTD). If 1 of three patients experiences dose-limiting toxicities (DLT), three more patients will be enrolled at the same dose level. The MTD is defined as the dose level at which two or more of three patients, or at least two of 4-6 patients, have DLTs during one cycle.
This is a single-arm study with all patients receiving these three drugs.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Surgery, Ruijin Hospital
Shanghai, 200025, China
Mei Y, Shi M, Zhu Z, Yuan H, Yan C, Li C, Feng T, Yan M, Zhang J, Zhu Z. Addition of sintilimab to nanoparticle albumin-bound paclitaxel and S-1 as adjuvant therapy in stage IIIC gastric cancer. Future Oncol. 2022 Jan;18(2):139-148. doi: 10.2217/fon-2021-1020. Epub 2021 Dec 8.
Zhenggang Zhu
Ruijin Hospital
Jun Zhang
Ruijin Hospital
First Submitted
February 28, 2021
First Posted
March 4, 2021
Study Start
March 1, 2021
Actual (reported)Primary Completion
March 1, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 4, 2021
Record last verified: 2021-03
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