Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of HCC Before Liver Transplant

Zhejiang University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Hepatocellular Carcinoma

Liver Transplant

Treatments

Drug: Camrelizumab plus apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04035876

KY2019-SHR-APA-ZJU

Details and patient eligibility

About

To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.

Full 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 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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