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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborators: First Hospital of Jilin University; Huashan Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shulan (Hangzhou) Hospital; The First Affiliated Hospital of Zhengzhou University; The First Hospital of Jilin University; Third Affiliated Hospital, Sun Yat-Sen University; Tianjin First Central Hospital; West China Hospital
• Treatments: Apatinib

Criteria

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