A Single Center, Multi Cohort, Phase I Basket Trial of the Safety and Efficacy of Camrelizumab in Combination With Bevacizumab and HAIC for Metastatic Liver Cancer After Standard Treatment Failure

Fudan University1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2022年12月最近更新: 2022年12月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Fudan University
入组人数: 80
试验地点: 1
主要终点: Incidence and degree of Adverse Events and Serious Adverse Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single center, multi-cohort, phase I basket trial to evaluate the safety and efficacy of camrelizumab in combination with bevacizumab and HAIC for metastatic liver cancer after standard treatment failure

详细描述

For patients with advanced primary liver cancer, immunotherapy combined anti-angiogenic therapy has gradually become the first-line standard treatment. However, for metastatic liver cancer, especially after first-line treatment failure, the current treatment options are mostly systemic chemotherapy, and there is still a lack of effective treatment methods. Compared with systemic chemotherapy, HAIC has a higher objective response rate and survival rate, and the incidence of adverse reactions is lower. At the same time, PD-1 combined with chemotherapy has become the first-line standard treatment for many cancers; referring to the expert consensus on liver metastasis of solid tumors and ongoing clinical research, the "PD-1 + anti-angiogenesis + HAIC" regimen can be used as a new research direction for posterior treatment for metastatic liver cancer.

In view of the failure of first-line chemotherapy, how to find effective chemotherapy drugs has become a top priority. HAIC guided by genetic testing may be able to screen out effective chemotherapy drugs

This study is an open-label, single-center, multi-cohort, phase I basket trial designed to explore safety and efficacy of "camrelizumab + bevacizumab + HAIC guided by genetic testing" for metastatic liver cancer after standard treatment failure

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: 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

•Informed consent has been signed
•Age ≥ 18 years old
•Liver metastases of solid tumors confirmed by histology or cytology (including but not limited to gastric cancer, breast cancer, lung cancer, nasopharyngeal cancer, thyroid cancer, melanoma, stromal tumor, sarcoma, etc.), including liver metastases at the time of diagnosis or liver metastases occurred after radical resection, and the primary tumor has been resected
•The investigator assessed that the liver metastasis could not be removed surgically
•Progression or intolerance after receiving standard systemic therapy (patients who have received first-line immunotherapy can still be enrolled)
•Child-Pugh score ≤ 7
•At least one measurable lesion (according to RECIST 1.1)
•Expected overall survival ≥ 3 months
•ECOG PS score: 0~1
•Has sufficient organ function within 14 days before the first administration, (1) Blood routine: WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥50×109/L; HGB≥90 g/L (2) Liver function: AST≤5.0×ULN; ALT≤5.0×ULN; TBIL≤2.0×ULN (3) Renal function: Cr≤1.5×ULN or CrCl ≥60 mL/min (4) Coagulation function: INR≤1.5; APTT≤1.5×ULN (5) HBV-DNA≤2×103 IU/ml (subjects with HBV-DNA>2×103 IU/ml can be enrolled and should receive antiviral treatment at the same time)
•Women of childbearing age must take contraceptive measures within 3 months from the first dose to the last use of the study drug

排除标准

•Patients had other malignant tumors in the past or at the same time (excluding non melanoma skin cancer, cervical carcinoma in situ, papillary thyroid cancer after treatment)
•Patients had a history of organ transplantation or hepatic encephalopathy
•Suffering from immunodeficiency disease within 7 days before the first administration, or receiving systemic hormone treatment (≥ 10mg/day prednisone or equivalent dose of other hormones), or other forms of immunosuppressive treatment
•Patients who are seriously allergic to iodized contrast agents, antibody drugs, calcium folinate, 5-FU, platinum drugs , (≥ grade 3)
•Participated in other clinical trials or received other test drugs within 4 weeks before the first administration
•Pregnant or lactating women or women of childbearing age are positive in the baseline pregnancy test
•Other factors that may affect the subject's safety or test compliance as judged by the investigator