NCT06721286招募中2 期
Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma (ICC) With High Risk of Recurrence, Phase II, Single-center, Randomized Controlled Trial
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1-year recurrence-free survival rate
研究概览
简要总结
This study was a randomized controlled trial to evaluate the efficacy and safety of toripalimab combined with GemCis (gemcitabine and cisplatin) as preoperative neoadjuvant therapy for resectable ICC at high risk of recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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, male or female;
- •Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met:
- •2.1 Single tumor, diameter greater than 5cm (T1b) 2.2 Single tumor with vascular invasion (T2), multiple tumors ≤ 3 2.3 Tumor penetrating visceral peritoneum (T3) or directly invading surrounding organs (T4) 2.4 Suspicious lymph node metastasis in Zone 8, 12 or 13
- •Can not received systemic treatment before participating in the study;
- •ECOG PS score 0-1;
- •The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.
- •Laboratory inspection shall meet the following requirements:
- •Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For men, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug.
- •The patient voluntarily participated and signed the informed consent form;
- •It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the requirements of the scheme.
排除标准
- •Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);
- •Any other research drugs within 4 weeks before enrollment;
- •Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);
- •Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
- •Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within one year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
- •Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause>38.5 ° C occurred during screening/before the first drug administration;
- •History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Live attenuated vaccine shall be inoculated within 4 weeks before the first administration or planned during the study period;
- •Suffered from or accompanied by other system malignant tumors in the last 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
- •Allergic to any test drug;
- •Pregnant and lactating women, fertile subjects are unwilling to take effective contraceptive measures;
- •Uncontrollable psychosis;
- •Other situations that the researcher thinks are not suitable for inclusion. If the patient has central nervous system metastasis, has serious laboratory examination abnormalities, and is accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.
研究组 & 干预措施
Preoperative neoadjuvant therapy group
Experimental
干预措施: Teripalimab (Drug)
Preoperative neoadjuvant therapy group
Experimental
干预措施: Gemcitabine + Cisplatin (Drug)
Preoperative neoadjuvant therapy group
Experimental
干预措施: Surgery (Procedure)
Control group
Experimental
干预措施: Surgery (Procedure)
结局指标
主要结局
1-year recurrence-free survival rate
时间窗: 1 year
次要结局
- 1-year OS(1 year)
- 2-year OS(2-year)
- ORR(1 year)
- DCR(1 year)
- R0 resection rate(1 year)
- 30 day postoperative complication rate(1 year)
- Occurrence of adverse reactions(1 year)
研究者
研究点 (1)
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