Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer.
This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib, 5 cases will be enrolled in each treatment group. In the phase II study, a total of 44 patients will be enrolled. Eligible patients will be registered and receive three cycles of SOX plus tislelizumab regimen. Simultaneously, LDRT will be planned and administered. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of chemotherapy plus tislelizumab. The primary endpoint of Phase Ib is to determine the optimal radiation dose for phase II study. The primary endpoint of phase II is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), objective response rate (ORR), 2-year disease-free survival (DFS) rate, 2-year overall survival (OS) rate and safety profile of the neoadjuvant regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
All patients will start with one cycle of neoadjuvant therapy of SOX plus tislelizumab regimen: S-1: 40-60 mg Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; tislelizumab: 200 mg, iv drip, d1, q3w. LDRT will be performed in the target area. After radiotherapy, patients will receive another two cycles of SOX plus tislelizumab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of SOX plus tislelizumab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with SOX regimen for up to 5 cycles.
pCR rate
defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy
Time frame: 5 months after the last subject participating in
R0 resection rate
defined as the rate of the complete surgical removal of any residual cancer cells in the tumor bed
Time frame: 5 months after the last subject participating in
MPR rate
defined as tumor residual cells ≤10% in the surgical specimen
Time frame: 5 months after the last subject participating in
ORR
defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR)) before surgery
Time frame: 5 months after the last subject participating in
2-year disease-free survival (DFS) rate
defined as the proportion of patients without disease relapse 2 years after enrolment
Time frame: every 3 month postoperation up to 24 months
2-year OS rate
defined as the proportion of patients survived 2 years after enrolment
Time frame: every 3 month postoperation up to 24 months
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