PD-1 Antibody(Tislelizumab) Plus Irinotecan Combined With POF in Treatment Naive Advanced Gastric Cancer: A Phase II Study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This study is a single center, phase II study, to evaluate the effectiveness and safety of PD-1 Antibody(Tislelizumab) Plus Irinotecan Combined With POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) , in the first-line treatment for patients with advanced/metastatic gastric cancer.
详细描述
This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to compare that ORR of patients with Tislelizumab plus Irinotecan and POF for advanced/metastatic gastric cancer.
In treatment period, patients will be administrated Tislelizumab plus Irinotecan and POF, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.
The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
- •With or without measurable lesions.
- •Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
- •Life expectancy ≥3 months.
- •With normal electrocardiogram results and no history of congestive heart failure.
- •With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
- •Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug
- •With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
- •With good compliance and agree to accept follow-up of disease progression and adverse events.
排除标准
- •Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
- •Patients with brain or central nervous system metastases, including leptomeningeal disease.
- •Pregnant (positive pregnancy test) or breast feeding.
- •Serious, non-healing wound, ulcer, or bone fracture.
- •Significant cardiac disease as defined as: unstable angina, New York Heart 6.Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
- •7.History of a stroke or CVA within 6 months. 8.Clinically significant peripheral vascular disease. 9.Inability to comply with study and/or follow-up procedures. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
研究组 & 干预措施
POFI and Tislelizumab
干预措施: Tislelizumab (Drug)
POFI and Tislelizumab
干预措施: Oxaliplatin (Drug)
POFI and Tislelizumab
干预措施: Levo-Leucovorin (Drug)
POFI and Tislelizumab
干预措施: 5-fluorouracil (Drug)
POFI and Tislelizumab
干预措施: Irinotecan Hydrochloride (Drug)
POFI and Tislelizumab
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: From enrollment to 12 month
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.The ORR will be reported by percentage with each arms and appropriate confidence intervals.
次要结局
- 1.Progression-Free Survival(PFS)(From enrollment to 12 month)
- Overall Survival (OS)(From enrollment to 12 month)
- Disease control rate(DCR)(From enrollment to 12 month)