This is a single-arm, phase II study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of apatinib and two-drug chemotherapy (S-1 plus nab-paclitaxel) as conversion therapy in patients with stage IV gastric cancer in China.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
a checkpoint inhibitor via blocking PD-1 (programmed cell death-1) site of signaling.
a multi-target anti-angiogenic tyrosine kinase inhibitor (TKI)
S-1 is an oral fluoropyrimidine consisting of tegafur (a prodrug that is converted to fluorouracil, mainly in liver microsomes but also in tumour tissue), gimeracil (an inhibitor of dihydropyrimidine dehydrogenase, which degrades 5-FU), and oteracil (which inhibits the phosphorylation of 5-FU in the gastrointestinal tract, thereby reducing the toxic effects of 5-FU in the intestinum).
Department of Gastric Surgery, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
R0-surgery conversion rate
The proportion of participants who underwent R0 surgery among all participants.
Time frame: up to one year
objective response rate (ORR)
The proportion of participants who achieved complete response(CR) or partial response(PR) per Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.1).
Time frame: up to one year
disease control rate (DCR)
The proportion of participants who achieved CR, PR or stable disease(SD) per RECIST v1.1.
Time frame: up to one year
conversion rate
The proportion of participants who underwent surgery among all participants.
Time frame: up to one year
overall survival (OS)
The time from the first dose of the study treatment to death from any cause.
Time frame: up to two years
event-free survival (EFS)
The time from the first dose of the study treatment to any of the following events: progression of disease, local or distant recurrence, or death due to any cause.
Time frame: up to two years
Treatment-Related Adverse Events (TRAEs)
The grade and proportion of participants who experienced TRAEs per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time frame: from the first day of treatment until 1 month after the end of treatment
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Nab paclitaxel is a albumin-bound well tolerated paclitaxel than traditional paclitaxel
surgery-related complications
Incidence and grade of surgery-related complications as assessed byper the Clavien-Dindo classification
Time frame: from the day of surgery to 30 days postoperatively