HCC
Conditions
Interventions
Had not received any systemic therapy for HCC group:Icaritin
Had failed one or more lines of previous systemic therapy or who could not tolerate subsequent continuous therapy group:Icaritin
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age of 18-75 years old (inclusive), male or female 2) Patients with histologically/cytologically confirmed HCC or cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC. 3) Is not suitable for radical surgery and/or local treatment, or has disease progression (>=4 weeks) after surgery and/or local treatment. Cohort 1: Patients had not received any prior systemic therapy for HCC, including systemic chemotherapy, anti-vascular therapy, molecular targeted therapy, and immunotherapy containing CTLA-4 and PD-1/PD-L1 monoclonal antibody. Cohort 2: patients who had failed one or more lines of previous systemic therapy or could not tolerate continued therapy. 4) ECOG PS score: 0-2 5) Child-Pugh grade B and C liver function. Patients with Child-Pugh grade C need to meet the following conditions: a. liver volume > 35%, no tumor invasion; b. The blood flow of bile duct, portal vein and caval vein was unobstructed. 6) Expected survival time >=12 weeks 7) At least one measurable lesion according to response Evaluation Criteria in Solid Tumors (RECIST 1.1), defined as a non-lymph node lesion with the longest single diameter >=10 mm or a lymph node lesion with the short diameter >=15 mm; Lesions that had been treated with radiotherapy or other local treatments had to be measured by dynamic contrast-enhanced CT/ dynamic contrast-enhanced MRI, had disease progression according to RECIST 1.1 criteria, and had a maximum diameter of >=10 mm 8) The main organ functions meet the following requirements: a. Total bilirubin =28g/L; b.AST, ALT=40×109/L e. Hemoglobin level >=80g/L f. White blood cell count >=2.0×109/L 9) Signed informed consent
Exclusion criteria
Exclusion criteria: 1) Known cholangiocarcinoma (ICC) or mixed HCC, sarcomatoid HCC, or fibrolamellar HCC 2) History of cancer other than HCC within 5 years; However, the study excluded localized tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ 3) Previous treatment-related toxicity (except alopecia) did not recover to = grade 1 (NCI-CTC AE v 5.0). 4) Moderate to massive ascites (score >2); Moderate to large volume, or clinical symptoms requiring drainage of pleural effusion, pericardial effusion 5) Severe active infection (> grade 2 NCI-CTC AE v 5.0) 6) Congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarction or significant valvular heart disease or uncontrolled arrhythmia 7) Subjects with clinically relevant ongoing complications from previous surgery were ineligible 8) Uncontrolled hypertension and gastrointestinal bleeding. 9) Current with grade >=3 (NCI-CTC AE v5.0) GI or non-GI fistulas 10) Evidence of a major coagulopathy or other overt bleeding tendency: clinically significant hemoptysis or neoplastic bleeding of any cause within the previous 2 weeks; A thrombotic or embolic event in the previous 6 months; The use of therapeutic anticoagulation (other than low-molecular-weight heparin) within the first 2 weeks; Antiplatelet therapy is required. Current or recent (previous 10 days) use of aspirin (> 325 mg/ day), clopidogrel (> 75 mg/ day), or treatment with dipyridamole, ticlopidine, or cilostazol. Patients with metastatic lesions invading large blood vessels, respiratory tract, or middle mediastinum, and with significant risk of bleeding. 11) Had central nervous system metastases with severe unhealed wounds, active ulcers, and untreated fractures 12) Received live vaccine within 30 days before randomization. 13) Have an active autoimmune disease requiring systemic treatment (i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive drugs) within the previous 2 years; However, replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) was not considered systemic therapy and was permitted 14) A history of definite interstitial lung disease or noninfectious pneumonia, unless caused by local radiotherapy; He had a history of active tuberculosis 15) Had a known history of human immunodeficiency virus (HIV) infection 16) Received prior allogeneic stem-cell or solid-organ transplantation 17) Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption 18) Had a known history of severe allergy to any monoclonal antibody, anti-angiogenesis targeted drug, or icaritin soft capsule components 19) Pregnant or lactating women unable or unwilling to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Conversion to Standard Treatment;Time to Conversion to Acceptable Standard Systemic Treatmen;TTP;PFS; | — |
Countries
China
Contacts
Public ContactWen tianfu
West China Hospital, Sichuan University
Outcome results
None listed