This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.
Subjects will be randomized in a 1:1 ratio into either the modified XELOX plus sintilimab group or the standard XELOX plus sintilimab group. The treatment option for the modified XELOX group (study group) is 200 mg of sintilimab IV Drip Q3W, 600 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 78 mg/m2 IV Drip Q3W. The treatment option for the standard XELOX group (control group) is 200 mg of sintilimab IV Drip Q3W, 1000 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 130 mg/m2 IV Drip Q3W. After 6 cycles of treatment, patients could choose capecitabine + sintilimab maintenance with a maximum treatment duration of 2 years. The primary endpoint of this study is the progression-free survival (PFS), defined as the time from random assignment of the subject to disease progression or death from any cause. All eligible patients will be randomly assigned to either the trial or control group in a 1:1 ratio based on the following stratification factors: Whether the PD-L1 CPS score \>= 5; Whether the age \>70 years old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
540
The treatment option for the modified XELOX group (study group) is 200 mg of sintilimab IV Drip Q3W, 600 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 78 mg/m2 IV Drip Q3W.
The treatment option for the standard XELOX group (control group) is 200 mg of sintilimab IV Drip Q3W, 1000 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 130 mg/m2 IV Drip Q3W.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe Affliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGTongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGThe Second Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITINGRuijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGWest China Hospital of Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
NOT_YET_RECRUITINGProgression-Free Survival (PFS)
Time from randomization to disease progression or death from any cause
Time frame: an average of 4 years
Objective Response Rates (ORR)
The percentage of subjects whose therapeutic effect evaluation is complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: an average of 4 years
Overall Survival (OS)
Time from randomization to death from any cause
Time frame: an average of 4 years
Disease Control Rate (DCR)
The percentage of subjects whose therapeutic effect evaluation is complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1.
Time frame: an average of 4 years
Duration of Response (DOR)
Time from achievement of a response to disease progression.
Time frame: an average of 4 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit. The higher score means the worse quality of life.
Time frame: an average of 4 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-STO22 (EORTC QLQ- STO22)
Quality of life in patients with colorectal cancer is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) STO22. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit. The higher score means the worse quality of life.
Time frame: an average of 4 years
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