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Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma
Guangzhou, China
Phase 3
Recruiting
Led By Ruihua Xu, MD
Research Sponsored by Sun Yat-sen University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 4 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
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.
Eligible Conditions
- Stomach Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ an average of 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS)
Secondary study objectives
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-STO22 (EORTC QLQ- STO22)
Disease Control Rate (DCR)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Modified XELOX + sintilimabExperimental Treatment1 Intervention
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. After 6 cycles of treatment, patients could choose capecitabine + sintilimab maintenance with a maximum treatment duration of 2 years.
Group II: Standard XELOX + sintilimabActive Control1 Intervention
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.
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Who is running the clinical trial?
Sun Yat-sen UniversityLead Sponsor
1,680 Previous Clinical Trials
4,540,226 Total Patients Enrolled
Ruihua Xu, MDPrincipal InvestigatorSun Yat-sen University
9 Previous Clinical Trials
1,644 Total Patients Enrolled