Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer
1 other identifier
interventional
650
1 country
1
Brief Summary
The purpose of this study is to estimate overall survival of Sintilimab+ oxaliplatin + capecitabine and placebo+ oxaliplatin + capecitabine, as first-line treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2022
CompletedMarch 1, 2023
February 1, 2023
2.5 years
November 14, 2018
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Overall survival (OS)of Sintilimab in combination with oxaliplatin + fluoropyrimidine versus placebo+oxaliplatin + fluoropyrimidine in all randomized participants;Overall survival(OS) of Sintilimab + oxaliplatin + capecitabine versus placebo+ oxaliplatin + capecitabine in participants with programmed cell death ligand 1 (PD-L1) expressing tumors (CPS\>=10)
Approximately 40 months after the first participant is randomized
Secondary Outcomes (5)
Progression Free Survivla (PFS)
Approximately 40 months after the first participant is randomized
Duration of Response (DoR)
Approximately 40 months after the first participant is randomized
Objective Response Rate (ORR)
Approximately 40 months after the first participant is randomized
Disease Control Rate (DCR)
Approximately 40 months after the first participant is randomized
Number of participants experiencing clinical and laboratory adverse events (AEs)
Approximately 40 months after the first participant is randomized
Study Arms (2)
Sintilimab+ Oxaliplatin +capecitabine
EXPERIMENTALplacebo +Oxaliplatin + Capecitabine
ACTIVE COMPARATORInterventions
Weight\<60Kg: 3mg/kg Q3W Weignt\>=60Kg:200 mg Q3W on Day 1 by IV infusion
130 mg/m\^2 Q3W on Day 1 by IV infusion
1000 mg/m\^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
Weight\<60Kg: 3mg/kg Q3W Weignt\>=60Kg:200 mg Q3W on Day 1 by IV infusion
Eligibility Criteria
You may qualify if:
- Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma.
- Male or Female at least 18 years of age
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Did not receive neoadjuvant or adjuvant treatment (chemotherapy,radiotherapy, or both) for their disease within the last 6 months
- Must agree to provide tumor tissue sample, either from a previous surgeryor biopsy , within 6 months or fresh, prior to the start of treatment in this study and Has a PD-L1 status determined by immunohistochemistry (IHC) at a central laboratory
- Has measurable or non-measurable (but assessable) disease as defined by RECIST 1.1 as determined by investigator assessment.
- Has adequate organ function.
- Expected survival\>=12 weeks.
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment.
- Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication.
You may not qualify if:
- Suspicious active bleeding or obstruction phenomenon and Has difficulty in swallow tablets and food
- HER2-positive status
- Has had previous therapy for unresectable locally advanced, recurrent or metastatic gastric/GEJ cancer
- Has received prior therapy with a dose of cisplatin\>=300 mg/m-\^2
- Has grade ≥ 2 peripheral sensory neuropathy
- Known DPD enzyme deficiency status (\>=grade 3 mucosal toxicity in previous fluorouracil treatment)
- Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
- Received systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
- Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
- Has had major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first dose of study medication, or anticipation of the need for major surgery during the course of study treatment
- Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication.
- Clinical significant ascites, including which can be detected in percussion, had been ever drained or still need to be controlled currently.
- Bilateral moderate pleural effusion, or a large amount of pleural effusion on one side, or has caused respiratory dysfunction requiring drainage.
- Bone metastasis with risk of paraplegia.
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fifth Medical Center,Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000, China
Related Publications (3)
Wu H, Shu W, Ding Y, Li Q, Li N, Wang Q, Chen Y, Han Y, Huang D, Jiang H. The immune signatures predict gastric/gastroesophageal junction cancer response to first-line anti-PD-1 blockade or chemotherapy. BMC Cancer. 2025 Aug 25;25(1):1369. doi: 10.1186/s12885-025-14805-6.
PMID: 40851062DERIVEDLi W, Wan L. Cost-utility of sintilimab plus chemotherapy vs chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction cancer in China. Expert Rev Pharmacoecon Outcomes Res. 2024 Jun;24(5):671-678. doi: 10.1080/14737167.2024.2341859. Epub 2024 Apr 11.
PMID: 38594905DERIVEDXu J, Jiang H, Pan Y, Gu K, Cang S, Han L, Shu Y, Li J, Zhao J, Pan H, Luo S, Qin Y, Guo Q, Bai Y, Ling Y, Yang J, Yan Z, Yang L, Tang Y, He Y, Zhang L, Liang X, Niu Z, Zhang J, Mao Y, Guo Y, Peng B, Li Z, Liu Y, Wang Y, Zhou H; ORIENT-16 Investigators. Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2064-2074. doi: 10.1001/jama.2023.19918.
PMID: 38051328DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2018
First Posted
November 19, 2018
Study Start
December 19, 2018
Primary Completion
June 20, 2021
Study Completion
October 21, 2022
Last Updated
March 1, 2023
Record last verified: 2023-02