CTRI/2023/07/055523尚未招募3 期
Trastuzumab plus chemotherapy vs Chemotherapy alone in first-line HER2 positive advanced biliary tract cancer patients - a randomized non-blinded two-arm Phase III prospective clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 196
- 试验地点
- 3
- 主要终点
- To evaluate the difference in progression free survival at 6 months between Trastuzumab chemotherapy combination & chemotherapy alone
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
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Histologically confirmed adenocarcinoma of the biliary tract, with the following specifications 2.HER2 positive (by IHC or FISH) unresectable or metastatic Biliary tract cancers.
- •3.Age more than or equal to 18 years, ECOG performance status 0 to
- •4.Patient does not have any contraindications to receive chemotherapy or trastuzumab.
- •5.Adequate hematological, hepatic, and renal function parameters 6.Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) more than or equal to 50% or above the lower limit of normal.
- •ECG with no clinically relevant abnormalities.
- •7.Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
- •8.Subjects must provide written informed consent prior to the performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments and procedures.
- •9.Subjects who have received adjuvant chemotherapy will be considered eligible provided that therapy is completed more than 12 months before study enrollment.
- •Patients who have received radiation therapy and surgery will also be eligible provided the interventions have been completed 3 weeks, before enrolment in the study.
- •10.Negative serum pregnancy test (if applicable) and willing for adequate contraception.
- •11.At least one measurable disease according to RECIST criteria.
- •12.A life expectancy of at least 12 weeks.
排除标准
- •1.Distal cholangiocarcinoma 2.Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab-paclitaxel, or trastuzumab.
- •3.Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III to IV.
- •4.Clinically significant valvular defect.
- •5.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.
- •6.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
- •7.Baseline neuropathy greater than NCI Grade I.
- •8.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
- •9.Received prior chemotherapy within 1 year.
- •10.Any active ILD or history of lung illness requiring bronchodilator drugs.
- •11.Patients with prior chemotherapy for metastatic disease will be ineligible for enrollment in the study.
结局指标
主要结局
To evaluate the difference in progression free survival at 6 months between Trastuzumab chemotherapy combination & chemotherapy alone
时间窗: To evaluate the difference in progression free survival at 6 months between Trastuzumab chemotherapy combination & chemotherapy alone
次要结局
- To evaluate the difference in Overall Survival between the Trastuzumab chemotherapy combination & chemotherapy alone.(To evaluate the difference in overall response rates between Trastuzumab chemotherapy combination and chemotherapy alone.)
研究者
研究点 (3)
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