Status:
UNKNOWN
Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of HCC Before Liver Transplant
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Shulan (Hangzhou) Hospital
West China Hospital
Conditions:
Hepatocellular Carcinoma
Liver Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04035876
Start Date
July 16 2019
End Date
December 31 2021
Last Update
July 29 2019
Active Locations (1)
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1
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China, 310003