Phase
Condition
Digestive System Neoplasms
Hepatic Fibrosis
Liver Disorders
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18-75 years
Pathology: hepatocellular carcinoma
Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor andAFP ≤ 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 ≤ 1.5ULN
ECOG: 0-2
Patients participate in the study voluntarily and sign informed consent
Exclusion
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 orintravenous steroid therapy
Long-term systemic hormone therapy (dose > 10mg prednisone/day) or any other form ofimmunosuppressive therapy
Myocardial ischemia or myocardial infarction above grade II, hypertension andinability 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 ofgastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoingthrombolytic 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
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting

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