EUCTR2018-000312-24-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma. - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able to provide written informed consent and can understand and comply with the requirements of the study
- •2. Adult patients (=18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent.
- •3. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
- •4. At least 1 measurable or non-measurable lesion as defined per RECIST v1.1 as determined by investigator assessment.
- •5. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. Note: Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
- •6. Patients must be able to provide tumor tissues.
- •7. ECOG PS = 1 within 7 days prior to randomization
- •8. Adequate organ function:
- •a. Absolute neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L, hemoglobin = 90 g/L. Note: Patients must not have required a blood transfusion or growth factor support = 14 days before sample collection
- •b. Serum creatinine = 1.5 x upper limit of normal (ULN) or estimated Glomerular Filtration Rate = 60 mL/min/1.73 m2. (Appendix 8)
- •c. Aspartate transaminase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
- •d. Serum total bilirubin = 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome)
- •e. International normalized ratio (INR) or prothrombin time (PT) = 1.5 x ULN unless patient is receiving anticoagulant therapy and PT values are within the intended therapeutic range of the anticoagulant
- •f. Activated partial thromboplastin time (aPTT) = 1.5 x ULN
- •g. Albumin = 3.0 g/dL or 30 g/liter
- •9. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control.
- •10. Non-sterile males must be willing to use a highly effective method of birth control.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 380
排除标准
- •1. Patient has squamous cell or undifferentiated or other histological type GC
- •2. Active leptomeningeal disease or uncontrolled brain metastasis.
- •3. Active autoimmune diseases or history of autoimmune diseases that may relapse.
- •4. Any active malignancy = 2 years before randomization, with the exception of the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively.
- •5. Uncontrollable pleural effusion, pericardial effusion, or ascites
- •requiring frequent drainage at least once a week) and/or diuretics
- •within 7 days prior to randomization (The cytological confirmation of any
- •effusion is permitted).
- •6. Have clinically significant bleeding (CTCAE = Grade 2) from the gastrointestinal (GI) tract within month prior to randomization
- •7. Have a history of = Grade 2 (CTCAE) GI perforation and/or fistulae (including prior gastric fistula operation) within 6 months prior to randomization
- •8. Have a clinically significant bowel obstruction (CTCAE = Grade 2)
- •9. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
- •10. Any condition that requires systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before randomization
- •11. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc.
- •12. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
- •13. A known history of HIV infection
- •14. Patients with cardiovascular risk factors.
- •15. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
研究者
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