This is a phase II, one-arm study, which is aiming to evaluate the feasibility of combination of Disitamab Vedotin, Sintilimab and S-1 as conversion therapy in patients with HER2 overexpression unresectable gastric cancer .
In this study, 30 HER2 overexpression unresectable gastric cancer patients will enrolle and treate with Disitamab Vedotin, Sintilimab and S-1. During the study period, imaging examinations were conducted every 6-12 weeks to evaluate the tumor and whether it reached the operable standard. The scheme and duration of postoperative adjuvant treatment were determined by the investigator according to the patient's conditions (Sintilimab was recommended to be maintained for 1 year, and other drugs were increased or decreased according to the patient's conditions). During the study, safety evaluation and effectiveness evaluation will be conducted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
R0 resection rate
The proportion of patients who underwent R0 surgery among all patients.
Time frame: 1 year
objective response rate (ORR)
The proportion of patients who achieved patial response and complete reponse per RECIST version 1.1.
Time frame: up to one year
overall survival (OS)
median OS or OS rate
Time frame: From the first dose to death from any cause, up to two years.
Recurrence free survival(RFS)
median RFS or RFS rate
Time frame: From the first dose to recurrence or death from any cause, up to two years.
safety profile
The grade and proportion of adverse events, treatment related adverse events, immune-related adverse events (irAEs), serious adverse events, and perioperative complications, etc.
Time frame: up to 30 days after last treatment administration
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Paclitaxel (PTX) was used with a dose of 60mg / m2, Q3W. (Only for patients with peritoneal metastases)