This is a multicenter, randomized, open-label, phase 2 clinical study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of fruquintinib and chemotherapy (S-1 plus nab-paclitaxel) versus sintilimab and chemotherapy as conversion therapy in patients with stage IV gastric cancer in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: Fruquintinib Fruquinitinib 4mg/d, QD, PO, D1-D14, Q3W 4-8 cycles Drug: S-1 BSA\<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel * without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles; * with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.
Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: S-1 BSA\<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel * without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles; * with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
R0-surgery conversion rate
The proportion of patients who underwent R0 surgery among all efficacy evaluable patients.
Time frame: about 3 years
Pathological complete response (pCR)
The proportion of patients with a pathological complete response (ypT0\&N0) at the time of definitive surgery among all patients who underwent conversation surgery.
Time frame: about 3 years
Major pathological response rate (MPR)
The proportion of patients with a major pathological response (≤10% residual viable tumor) at the time of definitive surgery among all patients who underwent conversation surgery.
Time frame: about 3 years
Rate of downstaging
To determine the rate of ypT0 and ypN0, and downstaging ratio of preoperative imaging clinical stage compared with baseline.
Time frame: about 3 years
Objective response rate (ORR)
The proportion of patients who achieved complete response (CR) or partial response(PR) per RECIST v1.1.
Time frame: about 3 years
Disease control rate (DCR)
The proportion of patients who achieved CR, PR or stable disease(SD) per RECIST v1.1.
Time frame: about 3 years
Overall survival (OS)
The time from the initial date of conversation therapy to the date of death due to any cause.
Time frame: about 3 years
Progression-free survival (PFS)
The time from the initial date of conversation therapy to the date of first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: about 3 years
Adverse event (AEs)
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Incidence and grade of surgery-related complications will also be as assessed.
Time frame: about 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.