A Single Group, Open Label, Multi-center Clinical Study of Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of Hepatocellular Cancer Before Liver Transplant
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Objective remission rate
研究概览
简要总结
To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
详细描述
HCC patients waiting for liver transplantation will be screened and enrolled according to the inclusion criteria. After screening and enrollment, patients will be administrated camrelizumab 200mg q2w iv and apatinib 250mg qd po regimen every 4 weeks as a cycle. Each patient will receive camrelizumab treatment for at least 2 cycles and discontinue camrelizumab 5 weeks before liver transplantation. Apatinib will be discontinued 1 week before liver transplantation. Once the tumor progression was detected, the program will be terminated and the appropriate optimal treatment will be given. The objective remission rate (ORR), recurrence-free survival (RFS), overall survival (OS), time to progress (TTP) and any adverse effect during the study will be evaluated in order to assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
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
- •18-75 years
- •Pathology: hepatocellular carcinoma
- •Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor and AFP ≤ 100 ng/mL; Type B: diameter of tumor >8 cm, but 100 ng/mL < AFP <400 ng/mL)
- •No interventional therapy (TACE, RFA or I131) within 2 month
- •Expected survival for more than 3 months
- •Child-pugh grade A or grade B (≤ 7 points)
- •Absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 9 g/L, PLT ≥ 100×10^9 /L; TSH ≤ ULN; total bilirubin ≤ 1.5 ULN, albumin ≥ 28 g/L, AST, ALT ≤ 3 ULN; serum creatinine ≤ 1.5 ULN
- •ECOG: 0-2
- •Patients participate in the study voluntarily and sign informed consent
排除标准
- •Regional lymph node metastases or extrahepatic metastases
- •Allergic to Camrelizumab or Apatinib
- •Patients who have had or are currently complicated with other malignant tumors
- •Active hepatitis (hepatitis B: HBsAg positive or HBV- DNA≥10⁴copies/ml; hepatitis C: HCV antibodies and HCV-RNA positive)
- •Activ pulmonary tuberculosis or pulmonary tuberculosis history
- •Active, diagnosed, or suspected autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma)
- •Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy
- •Long-term systemic hormone therapy (dose > 10mg prednisone/day) or any other form of immunosuppressive therapy
- •Myocardial ischemia or myocardial infarction above grade II, hypertension and inability to reach the normal range after medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)
- •Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L); history of gastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoing thrombolytic or anticoagulant treatment
- •Pregnant or lactating women
- •Patients who participated in other clinical trials within 1 month
- •Active infections which require systemic treatment
- •HIV positive
- •Other factors that may affect patients' safety or compliance
研究组 & 干预措施
Camrelizumab plus apatinib
干预措施: Camrelizumab plus apatinib (Drug)
结局指标
主要结局
Objective remission rate
时间窗: From enrollment to disease progression, up to 6 months
The proportion of patients with CR, PR, and SD in the group
Recurrence-free survival
时间窗: 1 year
The period from enrollment surgery to recurrence of HCC
次要结局
- Adverse effect(1 year)
- Overall survival(1 year)
- Time to progress(From enrollment to disease progression, up to 6 months)
研究者
Xiao Xu
Clinical Professor
Zhejiang University