Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The rate of overall response evaluated by MRI or CT
研究概览
简要总结
Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma. This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.
详细描述
Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma.
This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.
This phase 2 trial was designed to enroll 25 patients with BRCC who were assigned to mFOLFOXIRI neoadjuvant chemotherapy. The primary endpoint was the overall response rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old at the time of informed consent
- •Diagnosed with cholangiocarcinoma and the disease is measurable by RECIST 1.1 criteria
- •ECOG performance status of 0 or 1
- •No distant metastasis
- •The disease is either resectable or potentially resectable
- •Patients must have adequate organ function as defined by the following laboratory values at study entry:
- •Hemoglobin ≥ 8 g/dL (transfusions are acceptable) ANC ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L AST/ALT ≤ 3 x ULN Total bilirubin ≤ 2.5 mg/dL Creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
- •Women of childbearing potential definition (WOCBP) and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 3 months after the end of treatment.
- •WOCBP must have a negative serum or urine pregnancy test prior to initiation of treatment.
排除标准
- •> 75 years old
- •Prior therapy for cholangiocarcinoma with either surgery, radiation or chemotherapy
- •Other malignancies except for the following: adequately treated cervical carcinoma in situ and treated basal cell carcinoma.
- •Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
- •Pregnant or lactating women.
- •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •Liver disease including but not limited to cirrhosis, primary sclerosing cholangitis, future liver remnant of less than 20-30%
- •Comorbidity including but not limited to active clinically serious infections, congestive heart failure, life-threatening arrhythmia
- •known HIV positive
- •Baseline peripheral neuropathy/paresthesia grade ≥ 2.
研究组 & 干预措施
mFOLFOXIRI
mFOLFOXIRI consists of the following combination of drugs:
Oxaliplatin, 85 mg/m2, IV over 2 hours Leucovorin, 400 mg/m2, IV over 2 hours Irinotecan, 150 mg/m2, IV over 90 minutes 5 FU, 400 mg/m2, IV bolus 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection
each 14 day cycle, for 6 cycles
干预措施: mFOLFOXIRI (Drug)
结局指标
主要结局
The rate of overall response evaluated by MRI or CT
时间窗: Up to 15 weeks
The rate of response evaluated by MRI or CT according to RECIST 1.1 criteria
次要结局
- Resectability rate(Up to 24 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(every 15 days for approximately 24 weeks)
研究者
Jarin Chindaprasirt
Assistant professor
Khon Kaen University