TACE Combined With "Target Immune" Therapy for First-line Treatment Compared With Intravenous Chemotherapy in the Treatment of Unresectable Intrahepatic Cholangiocarcinoma: A Prospective, Multicenter, Open, Real-World Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 98
- 主要终点
- Progression-free Survival
研究概览
简要总结
This study is a prospective, multicenter, open, real-world clinical study. All eligible patients were assigned to experimental group (TACE combined with multi-target drugs and PD-1 inhibitors), and control group (conventional intravenous chemotherapy), to explore the efficacy and safety of TACE combined with multi-target drugs and PD-1 inhibitors as first-line treatment compared with traditional systemic intravenous chemotherapy in the treatment of unresectable intrahepatic cholangiocarcinoma (ICC).
详细描述
This study is a prospective, multi-center, open, and double-arm clinical study in the real world, which belongs to a practical clinical trial. The type of comparison is the non-inferiority test. This study enrolls 98 patients with unresectable intrahepatic cholangiocarcinoma at multiple centers across the country. In the experimental group, 49 patients will receive TACE combined with immune checkpoint inhibitors and multi-target drugs; In the control group, 49 patients will receive traditional systemic intravenous chemotherapy with GEMOX regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study is an open-label study. The participants and investigators are not blinded, but the outcomes assessor are blinded.
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
- •Patients shall be older than 18 years old and have no gender limitation;
- •Patients with intrahepatic cholangiocarcinoma confirmed by histopathology or clinical diagnosis and treatment standards who are inoperable or unwilling to undergo surgery at first diagnosis or who cannot be resected after recurrence;
- •Patients with measurable lesions that can be observed and evaluated and whose diameter≥1cm are accurately measured by MRI enhancement or Computed Tomography (CT) enhancement according to mRECIST criteria;
- •Patients with Child-Pugh A or B liver function grade and basically normal heart function;
- •ECOG PS score≤1;
- •Patients with expected survival > 3 months;
- •Patients who have voluntarily participated in the study, signed informed consent, had good compliance, and cooperated with follow-up;
- •There is no active HBV-DNA replication before enrollment (HBV-DNA<2000IU/mL), and HBV-positive patients have received anti-HBV treatment before enrollment.
排除标准
- •Pregnant women, breast-feeding women or patients of childbearing age planning;
- •Patients with severe heart, liver, and renal insufficiency and thyroid dysfunction;
- •Patients scheduled for liver transplantation;
- •Patients who have had or are currently suffering from other malignant tumors within five years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor;
- •Patients with pleural effusion or ascites, causing respiratory syndrome (≥ CTCAE grade 2 dyspnea);
- •Patients with unmitigated toxicity higher than CTCAE level 1 (5.0) due to any prior treatment;
- •Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, etc.);
- •Patients with symptoms and signs of interstitial diseases.
研究组 & 干预措施
Transcatheter arterial chemoembolization Combined With "Target Immune" Therapy
Transcatheter arterial chemoembolization combined with immune checkpoint inhibitors and multi-target drugs was used for treatment.
干预措施: Transcatheter arterial chemoembolization (Procedure)
Transcatheter arterial chemoembolization Combined With "Target Immune" Therapy
Transcatheter arterial chemoembolization combined with immune checkpoint inhibitors and multi-target drugs was used for treatment.
干预措施: Multi-target Drug Therapy (Drug)
Transcatheter arterial chemoembolization Combined With "Target Immune" Therapy
Transcatheter arterial chemoembolization combined with immune checkpoint inhibitors and multi-target drugs was used for treatment.
干预措施: Immunocheckpoint Inhibitor Therapy (Drug)
Traditional Systemic Intravenous Chemotherapy Group
Traditional systemic intravenous chemotherapy with GEMOX regimen was used for comparison.
干预措施: Systemic Intravenous Chemotherapy (Procedure)
结局指标
主要结局
Progression-free Survival
时间窗: The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years.
The most common primary endpoint in cancer trials. The 6 months, 1 year, and 2 years progression-free survival
次要结局
- Time To Tumor Untreatable Progression(The time interval between receiving TACE or intravenous chemotherapy and the patient's inability to receive further intra-arterial treatment, assessed up to 12 months.)
- Overall Survival(Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive.)
- Duration of Overall Response(The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months.)
- The incidence of adverse events and serious adverse events(The time from randomization to every follow-up time, assessed up to 2 years.)
- Objective Response Rate(Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria, assessed up to 12 months.)
- Disease Control Rate(Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.)