This study is a prospective, open label, phase II clinical study intended to include patients with locally advanced gastric adenocarcinoma who have not undergone any treatment and are eligible for surgery. The study aims to evaluate the efficacy and safety of the short course sequential radiotherapy regimen of Disitamab Vedotin combined with S-1 and Sintilimab in neoadjuvant therapy for HER2 expressing locally advanced gastric cancer.
This study is a prospective, open label, phase II clinical study intended to include patients with locally advanced gastric adenocarcinoma who have not undergone any treatment and are eligible for surgery. The study aims to evaluate the efficacy and safety of the short course sequential radiotherapy regimen of Disitamab Vedotin combined with S-1 and Sintilimab in neoadjuvant therapy for HER2 expressing locally advanced gastric cancer. After signing informed consent and screening to meet the inclusion criteria, the patient received full course neoadjuvant therapy: short course radiotherapy, rest for 1 week, sequential 3 cycles of Disitamab Vedotin combined with S-1 and Sintilimab, and preoperative imaging examination within 3-4 weeks after the last medication to evaluate the efficacy of neoadjuvant therapy and the possibility of curative D2 resection. The decision to undergo adjuvant treatment after radical surgery for gastric cancer is made by the researcher.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Short range radiotherapy, PCTV (clinical planned target area) DT 25Gy/5F, once a day, for a total of 5 days, continuous irradiation, and IMRT (intensity modulated radiation therapy) technology; After a week of rest, radiotherapy and chemotherapy combined with immunotherapy will be performed * Disitamab Vedotin: 2.5 mg/kg, intravenous infusion, d1, Q3W; * Sintilimab: 200mg, iv; * S-1: 40 mg/dose, oral, bid, d1-14; Q3W Whether to undergo adjuvant therapy after surgery is determined by the researcher
Zhang Tao
Wuhan, Hubei, China
RECRUITINGpathological complete response (pCR) rate
Pathological complete response rate (PCR) assessed by the blind independent Review Committee, defined as theabsence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes(yPTONO)
Time frame: an expected average of 4 months
Overall Survival
The time from the date of randomization to the death caused by any cause
Time frame: an expected average of 5 years
RO resection rate
The rate of negative margin microscopically
Time frame: an expected average of 5mouths
dverse events (AEs)
Adverse events and surgical safety
Time frame: an expected average of 5 years
Primary pathological response (MPR) rate
≤ 10% residual live tumor
Time frame: an expected average of 1 years
Disease free survival (DFS)
The time from surgical resection to local recurrence
Time frame: an expected average of 5 years
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