HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
概览
简要总结
Intrahepatic cholangiocarcinoma (ICC) has a poor prognosis. The aim of this study is to investigate the efficacy and safety of GP-HAIC combined with immunosuppressants in the treatment of initially unresectable ICC patients, as well as its role in conversion therapy. A prospective study was conducted on the data of locally advanced unresectable ICC patients receiving GC-HAIC combined with immunosuppressive therapy, evaluating the treatment efficacy and safety.
详细描述
Hepatic arterial infusion chemotherapy (HAIC)-GC（Gemcitabine+Cisplatin） combined with Durvalumab OR Pembrolizumab
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
- 是
入选标准
- •Age: Age ≥ 18 years old.
- •Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.
- •Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).
- •Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or
- •Expected lifespan: Expected lifespan ≥ 3 months.
- •Liver function: Child Pugh classification A or B.
- •Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol.
- •Not receiving relevant treatment: Not receiving systematic treatment for ICC.
排除标准
- •Previous treatment: Previously received systemic treatment for ICC.
- •Poor physical condition: ECOG physical condition score ≥
- •Poor liver function: Child Pugh grading\>
- •Short life expectancy: Life expectancy is less than 3 months.
- •Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors.
- •Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys.
- •Drug allergy or intolerance: Allergic to the investigational drug or its excipients.
- •Other: Other situations that the researcher deems unsuitable to participate in this study
研究组 & 干预措施
HAIC combined with PD-L1 inhibitor
Hepatic arterial infusion chemotherapy (HAIC) combined with PD-L1 inhibitor 1.Therapy:hepatic
arterial infusion chemotherapy (HAIC) hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was
adopted, with the specific regimen as follows: Cisplatin 20mg/m2, maintained for 3 hours. Gemcitabine 0.6g/m2,
maintained for 1 hour , repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles
was determined by the investigator according to the patient's condition). 2. PD-L1 inhibitor Drug: Durvalumab
OR pembrolizumab Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5
of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W Pembrolizumab:
During combination therapy: 200 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle
(determined by the investigator); during maintenance therapy: 200 mg Q4W
干预措施: PD-L1 inhibitor (Drug)
HAIC combined with PD-L1 inhibitor
Hepatic arterial infusion chemotherapy (HAIC) combined with PD-L1 inhibitor 1.Therapy:hepatic
arterial infusion chemotherapy (HAIC) hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was
adopted, with the specific regimen as follows: Cisplatin 20mg/m2, maintained for 3 hours. Gemcitabine 0.6g/m2,
maintained for 1 hour , repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles
was determined by the investigator according to the patient's condition). 2. PD-L1 inhibitor Drug: Durvalumab
OR pembrolizumab Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5
of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W Pembrolizumab:
During combination therapy: 200 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle
(determined by the investigator); during maintenance therapy: 200 mg Q4W
干预措施: HAIC (Procedure)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 2 year
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
次要结局
- Overall Survival (OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Progression-free Survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
研究者
Chengjun Sui,MD
Professor
Eastern Hepatobiliary Surgery Hospital