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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma, Liver Transplant

Intervention / Treatment
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* Drug: Camrelizumab plus apatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Camrelizumab plus apatinib<br> | Drug: Camrelizumab plus apatinib<br>* Camrelizumab 200mg q2w iv and apatinib 250mg qd po.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective remission rate | The proportion of patients with CR, PR, and SD in the group | From enrollment to disease progression, up to 6 months | 
| Recurrence-free survival | The period from enrollment surgery to recurrence of HCC | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The survival rate in a year | 1 year | 
| Time to progress | The period from enrollment to disease progression | From enrollment to disease progression, up to 6 months | 
| Adverse effect | Any adverse effects occur during the project | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Camrelizumab, Apatinib, HCC, Liver transplantation