jRCTs031220099招募中不适用
Master protocol trial for rare fractions of hepato-pancreato-biliary cancer and neuroendocrine tumor.
未提供0 个研究点目标入组 68 人开始时间: 2022年8月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 主要终点
- Objective response rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Pathologically confirmed undifferentiated carcinoma of the pancreas;
- •(2) Unresectable disease diagnosed by contrast-enhanced CT (chest, abdomen, and pelvis) and/or MRI (abdomen and pelvis) imaging;
- •If the patient received adjuvant chemotherapy and the diasese recurred within 6 months after the completion, the patient is excluded from this study.
- •(3) At least 20 years of age;
- •(4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •(5) Measurable disease by RECIST v1.1 criteria;
- •(6) No prior treatment for undifferentiated carcinoma of the pancreas;
- •(7) Adequate hematologic and organ function defined by the following laboratory test results, obtained within 7 days prior to study enrollment:
- •Absolute neutrophil count (ANC) >=1,500 /mm3,
- •Hemoglobin >= 8.0 g/dL,
- •Platelet count >= 10^4/mm3,
- •Serum total bilirubin <= 2.0 mg/dL,
- •Aspartate transaminase (AST) < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
- •Alanine transaminase (ALT) < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
- •Serum creatinine (Cr) <= 1.2 mg/dL
- •(8) Signed written informed consent form.
- •(1) Pathologically confirmed acinar cell carcinoma of the pancreas;
- •(2) Unresectable disease diagnosed by contrast-enhanced CT (chest, abdomen, and pelvis) and/or MRI (abdomen and pelvis) imaging;
- •If the patient received adjuvant chemotherapy and the diasese recurred within 6 months after the completion, the patient is excluded from this study.
- •(3) 20-75 years of age;
- •(4) ECOG performance status of 0-1;
- •(5) Measurable disease by RECIST v1.1 criteria;
- •(6) No prior treatment for acinar cell carcinoma of the pancreas;
- •(7) Peripheral motor or sensory neuropathy <= grade 1;
- •(8) None of UGT1A1 polymorphisms (UGT1A1*6/*6, UGT1A1*28/*28, and UGT1A1*6/*28);
- •(9) Adequate hematologic and organ function defined by the following laboratory test results, obtained within 7 days prior to study enrollment:
- •Absolute neutrophil count (ANC) >=1,500 /mm3,
- •Hemoglobin >= 8.0 g/dL,
- •Platelet count >= 10^4/mm3,
- •Serum total bilirubin <= 1.5 mg/dL,
- •AST < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
- •ALT < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
- •Cr <= 1.2 mg/dL
- •(10) Signed written informed consent form.
- •(1) Pathologically confirmed adenocarcinoma;
- •(2) Metastatic or recurrent* pancreatic cancer diagnosed diagnosed by contrast-enhanced CT (chest, abdomen, and pelvis) and/or MRI (abdomen and pelvis) imaging;
- •If the patient received adjuvant chemotherapy and the diasese recurred within 6 months after the completion, the patient is excluded from this study.
- •(3) Presence of UGT1A1 polymorphisms (UGT1A1*6/*6, UGT1A1*28/*28, and UGT1A1*6/*28);
- •(4) 20-75 years of age;
- •(5) ECOG performance status of 0-1;
- •(6) Measurable disease by RECIST v1.1 criteria;
- •(7) No prior treatment for pancreatic cancer;
- •(8) Peripheral motor or sensory neuropathy <= grade 1;
- •(9) Adequate hematologic and organ function defined by the following laboratory test results, obtained within 7 days prior to study enrollment:
- •Absolute neutrophil count (ANC) >=1,500 /mm3,
- •Hemoglobin >= 8.0 g/dL,
- •Platelet count >= 10 x 10^4/mm3,
- •Serum total bilirubin <= 2.0 mg/dL,
- •AST < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
- •ALT < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
- 另有 18 项未显示
排除标准
- •(1) History of malignancy (except for adequately treated carcinoma in situ, non-invasive cancer) within 2 years prior to study entry except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years;
- •(2) Evidence of uncontrolled, active infection, requiring anti-infectious treatment, except for viral hepatitis;
- •(3) Known central nervous system metastases (imaging required only if participants are symptomatic);
- •(4) Symptomatic ascites or pleural effusion;
- •(5) Significant lung disease, including interstitial lung disease, pulmonary fibrosis, or severe emphysema;
- •(6) Active watery diarrhea;
- •(7) Pregnant, lactating or females of childbearing age unless using highly effective contraception;
- •(8) Male with partner of child-bearing potential unless using highly effective contraception;
- •(9) Patients with significant psychiatric disorder;
- •(10) History of arterial thromboembolism (e.g., myocardial infarction, unstable angina, and cerebral infarction) within 6 months prior to the initiation of study treatment;
- •(11) Significant comorbidities, such as uncontrolled diabetes mellitus, uncontrolled hypertension, New York Heart Association (NYHA) Class III or greater cardiac disease, chronic kidney disease, or liver dysfunction;
- •(12) Requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medication;
- •(13) Esophageal or gastric varices with a risk of bleeding without preventive treatment;
- •(14) History of hypersensitivity to the study drugs used in each cohort;
- •(15) Patients whose entry in the study is considered by the investigator to be inappropriate.
结局指标
主要结局
Objective response rate
Cohort A: Objective response rate Cohort B: Objective response rate Cohort C: Objective response rate Cohort D: Objective response rate
次要结局
未报告次要终点
研究者
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