Tislelizumab in Combination With Pre-operative Chemoradiotherapy Versus SOC for Patients With Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Multicenter, Randomized, Open-label, Phase IIB Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3\
⁃ 4aN+M0 or T4bNanyM0 （AJCC Version 8）
• Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
• Has adequate organ function.
• Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
• Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
Locations
Other Locations
China
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Shanxi Province Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Wuhan Tongji Hospital
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Jia Wei, MD
jiawei99@nju.edu.cn
0086-025-83304616
Time Frame
Start Date:2023-03-15
Estimated Completion Date:2027-08-31
Participants
Target number of participants:140
Treatments
Experimental: Arm A: Tislelizumab + Chemoradiotherapy
Neoadjuvant: Prior to surgery, participants receive 4 cycles of Tislelizumab 200 mg via intravenous (IV) infusion on C1D1, C2D1, C2D22, C3D1 PLUS radiotherapy (TOMO or VMAT) 45Gy/1.5f PLUS S-1 initial dose depends on the body surface area, PO, bid, C1D1\~D14，C2D1\~C2D5, C2D8\~C2D12, C2D15\~C2D19, C2D22\~C2D26, C2D29\~C2D33, C3D1\~D14 and oxaliplatin 130mg/m\^2, IV, C1D1 and C3D1 OR S-1 initial dose depends on the body surface area, PO, bid, C1D1\~D14，C3D1\~D14 and nab-paclitaxel, IV 100\~120mg/m\^2，IV，C1D1，C1D8，C2D1，C2D8，C2D16，C2D22，C3D1 and C3D8.~Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of SOX OR S-1 and nab-paclitaxel AND 3 cycles of S-1, AND up to 16 cycles of Tislelizumab 200 mg via IV infusion on Day 1 Q3W.
Active_comparator: Arm B: Chemoradiotherapy
Neoadjuvant: Prior to surgery, participants receive radiotherapy (TOMO or VMAT) 45Gy/1.5f PLUS S-1 initial dose depends on the body surface area, PO, bid, C1D1\~D14，C2D1\~C2D5, C2D8\~C2D12, C2D15\~C2D19, C2D22\~C2D26, C2D29\~C2D33, C3D1\~D14 and oxaliplatin 130mg/m\^2, IV, C1D1 and C3D1 OR S-1 initial dose depends on the body surface area, PO, bid, C1D1\~D14，C3D1\~D14 and nab-paclitaxel, IV 100\~120mg/m\^2，IV，C1D1，C1D8，C2D1，C2D8，C2D16，C2D22，C3D1 and C3D8.~Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of SOX OR S-1 and nab-paclitaxel AND 3 cycles of S-1.
Active_comparator: Arm C: Chemotherapy
Neoadjuvant: S-1 initial dose depends on the body surface area, PO, bid, D1\~D14，Q 3W for 6 cycles, and oxaliplatin 130mg/m\^2, IV, D1 of each cycle for 6 cycles OR nab-paclitaxel, IV 100\~120mg/m\^2，IV，D1 and D8 for each cycle for 6 cycles.~Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of SOX OR S-1 and nab-paclitaxel AND 3 cycles of S-1.