NCT04479904撤回2 期
A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Objective response rate per RECIST 1.1
研究概览
简要总结
This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.
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
- 否
入选标准
- •Voluntary participation and written informed consent;
- •Aged 18-75 years (inclusive), males and females;
- •Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;
- •FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;
- •At least one measurable lesion that has not been treated locally;
- •ECOG score of 0-1;
- •Expected survival ≥ 12 weeks;
排除标准
- •Presence of multiple factors affecting oral medications;
- •Wounds unhealed over a long period of time, or fractures not completely healed;
- •Known or suspected allergy to investigational drug or any drug related to this trial.
- •Known cases of CNS(Central Nervous System) metastasis;
- •Uncontrolled cardiac diseases or symptoms;
- •Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants;
- •Patients previously treated with FGFR inhibitors (such as erdafitinib)
研究组 & 干预措施
famitinib
Experimental
干预措施: Famitinib (Drug)
结局指标
主要结局
Objective response rate per RECIST 1.1
时间窗: up to 24 months
次要结局
- DOR(At pre-defined intervals from initial dose up to 24 months)
- PFS(At pre-defined intervals from initial dose up to 24 months)
- Plasma concentrations of famitinib and its N-desethyl metabolite(At pre-defined intervals from initial dose up to 24 months)
- DCR(At pre-defined intervals from initial dose up to 24 months)
- OS(At pre-defined intervals from initial dose up to 24 months)
- Adverse events (AE) and serious adverse event (SAE)(At pre-defined intervals from initial dose up to 24 months)
研究者
相似试验
尚未招募
2 期
Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal CancerMSI-H Colorectal CancerTislelizumabOxaliplatinCapecitabineNCT05841134The First Affiliated Hospital of Zhengzhou University25
Unknown
2 期
An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic CholangiocarcinomaExtrahepatic CholangiocarcinomaNCT05448183Xuhua Duan45
进行中（未招募）
2 期
TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT05955391Shenzhen TargetRx, Inc.164
Unknown
2 期
Anti-PD-1 Antibody in the Treatment of Patients With Malignant Melanoma of the Female Genital TractMalignant MelanomaNCT04593485Fudan University40
Unknown
2 期
Eribulin Combined With Anlotinib in Metastatic HER2 Negative Breast CancerHER2-negative Breast CancerNCT04624711The First Affiliated Hospital with Nanjing Medical University40