Recombinant Human Adenovirus Type 5 Combined With Hepatic Artery Infusion Chemotherapy of FOLFOX in Patients With Intrahepatic Mass-forming Cholangiocarcinoma: a Single-site, Single-arm, Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Oncolytic viruses can selectively replicate in and destroy tumor cells. Recent studies indicate that recombinant human adenovirus type 5 (H101), which is the first approved oncolytic virus drug in the world, shows anti-tumor effects on liver cancer. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with HAIC in the treatment of intrahepatic mass-forming cholangiocarcinoma.
详细描述
This is a perspective, single-arm trial. According to previous studies, the PFS of HAIC for unresectable intrahepatic cholangiocarcinoma is approximately 8 - 10 months, and one year progression free rate is about 40%. We assumed that the study could detect 20% absolute difference and 1 year PFS rate could achieve 60% PFS by (FOLFOX + H101) over conventional HAIC (FOLFOX). Simon's two-stage design is used to estimate the sample size, with α value of 0.05 and power of 0.9. A total sample size of 66 participants are required.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, male or female
- •Histologically or cytologically confirmed intrahepatic mass-forming cholangiocarcinoma (IMCC) with unresectable lesion(s) or patients who refuse surgery
- •At least one measurable lesion according RECIST v1.1 criteria [spiral CT/MRI scan ≥ 10 mm (CT scan slice thickness no greater than 5 mm)]
- •Life expectancy ≥ 3 months
- •The function of vital organs meets the following requirements: absolute neutrophil count (ANC) ≥ 3.5 × 10^9/L; platelets ≥ 125 × 10^9/L; hemoglobin ≥ 8 g/dL; Serum albumin ≥ 2.8 g/dL; bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 ULN; ALT/AST in the presence of liver metastases ≤ 5 ULN; creatinine ≤ 1.5 ULN; euthyroid; LVEF > 50%
- •The date of the first dose of study drug is ≥ 21 days from the date of previous anti-tumor treatment, and has recovered from adverse reactions to prior anti-tumor therapy to baseline or lower than grade 1 (according to CTCAE Version 5.0)(except alopecia)
- •Female patients of childbearing potential (including early menopause, menopause < 2 years, and non-surgical sterilization), male patients and their partners must agree to use effective contraceptive measures during the study
- •Patients or their legal representatives can understand and offer informed consent, being willing to take part in the follow-up with good compliance
排除标准
- •Pregnant or lactating women, men or women who are reluctant to take effective contraceptive measures
- •Previous treatment with oncolytic viruses (such as T-VEC)
- •Abnormal coagulation function, or having a bleeding tendency, or receiving thrombolytic or anticoagulant therapy
- •Patients with poor glycemic control
- •Known central nervous system tumors, including metastatic brain tumors
- •Accompanied by any unstable systemic diseases, including but not limited to severe infection, resistant hypertension, unstable angina, stroke or myocardial infarction within 6 months, congestive heart failure, and serious cardiac arrhythmia requiring medication, renal or metabolic disease requiring medication
- •Known hypersensitivity to the study drug or oxaliplatin, leucovorin calcium, fluorouracil
- •History of immunodeficiency or autoimmune disease, or receiving long-term systemic steroid therapy within 7 days before enrollment, or any form of immunosuppressive therapy
- •Other conditions that are not suitable for participating in this trial
研究组 & 干预措施
H101+HAIC
Recombinant Human Adenovirus Type 5 (H101): intratumorally injected 3 days before HAIC. 1 vial (5.0 × 10^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10^12 vp) if the maximum diameters of lesion is > 10 cm.
HAIC (FOLFOX): Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium
干预措施: Recombinant Human Adenovirus Type 5 (Drug)
H101+HAIC
Recombinant Human Adenovirus Type 5 (H101): intratumorally injected 3 days before HAIC. 1 vial (5.0 × 10^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10^12 vp) if the maximum diameters of lesion is > 10 cm.
HAIC (FOLFOX): Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium
干预措施: HAIC of FOLFOX (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 1 month
The median amount of time from registration until disease progression or death, whichever occurs first. Disease progression was assessed via RECIST 1.1 criteria.
次要结局
- Disease control rate (DCR)(up to 1 month)
- 1 year survival rate(1 year)
- Objective response rate (ORR)(up to 1month)