Hepatocellular Carcinoma, Liver Transplant
Conditions
Keywords
Camrelizumab, Apatinib, HCC, Liver transplantation
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 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.
Interventions
Camrelizumab 200mg q2w iv and apatinib 250mg qd po.
Sponsors
Shulan (Hangzhou) Hospital
West China Hospital
Huashan Hospital
Third Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Zhengzhou University
The First Hospital of Jilin University
Tianjin First Central Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective remission rate | From enrollment to disease progression, up to 6 months | The proportion of patients with CR, PR, and SD in the group |
| Recurrence-free survival | 1 year | The period from enrollment surgery to recurrence of HCC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year | The survival rate in a year |
| Time to progress | From enrollment to disease progression, up to 6 months | The period from enrollment to disease progression |
| Adverse effect | 1 year | Any adverse effects occur during the project |
Countries
China
Contacts
Primary ContactJianguo Wang, PhD
Outcome results
None listed