JPRN-jRCT2091220436已完成1 期
Phase I/II study of Nivolumab plus Lenvatinib for advanced biliary tract cancer - SNIPE trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically proven adenocarcinoma
- •2) Unresectable or recurrent biliary tract cancer
- •3) [Phase I/II parts] after 1st line chemotherapy including Gemcitabine except surgery and biliary drainage for biliary tract cancer, and refractory to treatment, [Expansion cohort] no previous treatment except surgery and biliary drainage for biliary tract cancer
- •4) Recurrence more than 24 weeks (168 days) after ending of adjuvant S-1
- •5) age >=20 years
- •6) Performance status (Eastern Cooperative Oncology Group) of 0 or 1
- •7) adequate oral intake
- •8) More than one measurable region is required within 21 days before registration
- •9) no evidence of symptomatic brain metastasis, peritonitis carcinomatosis, nor spinal metastasis requiring radiotherapy
- •10) no evidence of pericardial fluid, pleural effusion or peritoneal effusion
- •11) Adequately controlled blood pressure irrespective usage of antihypertensive agent
- •12) No previous treatment of Lenvatinib, anti-PD-L1 antibody (Nivolumab, Pembrolizumab, etc.) anti-PD-1 antibody (Atezolizumab, Avelumab, Durvalumab, etc.), anti-CTLA-4 antibody (Ipilimumab etc.), and other agents controlling T-cell function.
- •13) No use of anticoagulant agent and antiplatelet agent.
- •14) No prior treatment (anticancer agent, radiotherapy including gamma knife, cyber knife, immunotherapy, anticancer vaccine) within 21 days before registration, except palliative radiotherapy for bone metastasis
- •15) No surgery under general anesthesia within 28 days before registration
- •16) Fulfilling all of (1)-(9) within 14 days before registration
- •(1) Neutrophil count >= 1,500 /mm3
- •(2) Platelets >= 100,000 /mm3
- •(3) Hemoglobin >= 8.5 g/dL
- •(4) AST <= 100 U/L ( or <= 150 U/L under biliary drainage)
- •(5) ALT <= 100 U/L ( or <= 150 U/L under biliary drainage)
- •(6) Serum total bilirubin <= 2.0 mg/dL
- •(7) Serum creatinine <= 1.2 mg/dL
- •(8) PT-INR <= 1.5
- •(9) Fulfill (i) or (ii)
- •(i) Negative or -1 urinary protein
- •(ii) if more than +1 urinary protein, 24-hour urinary protein excretion <=1g
- •17) Given consent to contraception
- •18) Written informed consent
排除标准
- •1) Synchronous or metachronous (within 2 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy
- •2) Active infection requiring systemic therapy
- •3) Active hemoptysis (more than half a teaspoon of blood) within 21days before registration
- •4) Interstitial pneumonia and/or pulmonary fibrosis diagnosed by chest CT imaging or clinical examinations
- •5) Either HIV antibody, HTLV-1 antibody, HBs antigen, or HCV antibody is positive (except for HCV-RNA-negative even if HCV antibody-positive)
- •6) In case of Hbs antigen negative, HBs antibody or HBc antibody is positive, and HBV-DNA quantitative test positive
- •7) Pregnant or breast-feeding women, or women suspected of being pregnant
- •8) Psychiatric diseases or psychological symptoms interfering with participation in the trial
- •9) Taking Steroid equivalent more than 10 mg/day of prednisolone or systemic immunosuppressant (oral or intravenous) except temporary use for examination or prevention
- •10) History or complication due to hypersensitivity of antibody drug
- •11) Severe complication (cardiac insufficiency, renal insufficiency, liver insufficiency,
- •hemorrhagic peptic ulcer, paresis of intestine, ileus, uncontrolled diabetes mellitus, unhealed wound, or bone fracture)
- •12) Unstable angina pectoris within 3 weeks before registration, or myocardial infarction within 6 months before registration,
- •13) Grade >=2 adverse reactions caused by prior therapy except any grade of alopecia and Grade 2 of hypersensitivity and skin hyperpigmentation
- •14) Intestinal malabsorption, post total gastrectomy, or disease affecting absorption of Lenvatinib
- •15) Uncontrolled thyroid function with medication
- •16) long QTc interval (Fridericia's formula) more than 480 ms
- •17) Hemorrhagic disease or Thrombotic disease
- •18) Taking agent with strong cytochrome P450 (CYP)3A4 inhibition or induction
- •19) Active autoimmune disease except (1)-(4)
- •(1) vitiligo vulgaris, controlled type I diabetes mellitus, improved childhood asthma, and improved atopic dermatitis
- •(2) Current normal thyroid function with suspect of autoimmune thyroid dysfunction
- •(3) dysthyroidism able to maintain normal thyroid function only with hormonal therapy
- •(4) Psoriasis not requiring systemic therapy
研究者
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