NCT03299946已完成1 期
Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年5月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of adverse events in participants of neoadjuvant cabozantinib plus nivolumab.
研究概览
简要总结
The proposed study is an open-label, single institution, single arm phase 1b study of neoadjuvant cabozantinib plus nivolumab in patients with locally advanced HCC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have locally advanced/borderline resectable hepatocellular carcinoma.
- •Must have measurable disease.
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- •Patients must have adequate liver remnant and function.
- •Antiviral therapy per local standard of care for hepatitis B.
- •Woman of child bearing potential must have a negative pregnancy test.
- •Must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Fibrolamellar carcinoma or mixed HCC.
- •Chemotherapy, radiotherapy, investigational therapy, or surgery less than 6 months prior to trial registration.
- •Concomitant Anticoagulation therapy.
- •Any GI or pulmonary risks of bleeding.
- •History of HIV Infection.
- •Active co-infection with hepatitis B and hepatitis C.
- •Active co-infection with hepatitis B and hepatitis D.
- •Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy.
- •History of any autoimmune disease requiring systemic treatment within the past 2 years. Any patient bearing an allograft is not eligible.
- •Any additional malignancies with treatment or life-limiting cancers. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial.
- •Uncontrolled intercurrent illness.
- •Corrected QT interval calculated by the Fridericia formula.
- •Uncontrolled high blood pressure.
- •Are pregnant or breastfeeding.
- •Any gastrointestinal (GI) disorders.
- •Any certain study-specified heart conditions 6 months prior to enrollment.
- •Major surgery within 2 months before enrollment.
- •Have any evidence of moderate or severe ascites.
- •Any untreated or incompletely treated varices with bleeding or high-risk bleeding.
- •Inability to swallow intact tablets.
- •Known or suspected hypersensitivity to study treatment.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Cabozantinib (Drug)
Arm 1
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Number of adverse events in participants of neoadjuvant cabozantinib plus nivolumab.
时间窗: 4 years
Number of patients who complete pre-op treatment and proceed to surgery.
时间窗: 4 years
次要结局
- Objective response rate (ORR)(4 years)
- Median Overall Survival (OS)(5 years)
- Percentage of participants who obtain a pathologic complete response (CR).(4 years)
- Percentage of participants who obtain a major pathologic responses (MPR)(4 years)
- Disease free survival (DFS)(5 years)
- Percentage of participants who obtain R0 resection.(4 years)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Trial of Cabozantinib (XL184) in Non-Small Cell Lung Cancer With Brain MetastasesNon Small Cell Lung Cancer (NSCLC)Metastases to the BrainNCT02132598Liza Villaruz, MD5
终止
1 期
Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the ExtremitiesSarcoma of the ExtremityStage I Soft Tissue Sarcoma of the Trunk and ExtremitiesStage IA Soft Tissue Sarcoma of the Trunk and ExtremitiesStage IB Soft Tissue Sarcoma of the Trunk and ExtremitiesStage II Soft Tissue Sarcoma of the Trunk and ExtremitiesNCT04220229University of Washington6
招募中
早期 1 期
Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical ResectionIntrahepatic CholangiocarcinomaNCT06406816Yongyi Zeng10
已完成
2 期
Cabozantinib in Combination With Avelumab in Patients Refractory to Standard Chemotherapy With Advanced Neuroendocrine Neoplasias G3 (NEN G3)CancerNCT05289856Johannes Gutenberg University Mainz30
进行中（未招募）
2 期
Neoadjuvant/Adjuvant Pembrolizumab Plus ChemotherapyNon Small Cell Lung CancerNeoadjuvant TherapyImmune Checkpoint InhibitorNCT05383716Peking Union Medical College Hospital80