Liver cancer
Conditions
Interventions
treatment group:Vorolanib + everolimus
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Genetically tested with a TSC1/2 mutation 2. strict clinical diagnostic criteria or confirmed diagnosis of unresectable or metastatic hepatocellular carcinoma (HCC) by histology or cytology, with at least one measurable lesion that meets RECIST 1.1 criteria 3. 1-2 prior systemic therapies with progression or intolerance; 4. age >= 18 years; 5. ECOG 0-1 with Child - Pugh score = 12 weeks; 8. adequate organ reserve function: Total bilirubin = 60mL/min. Urine protein is =1.0 x 10^9/L, haemoglobin >=9 g/dL, platelets >=75 x 10^9/L. International Normalised Ratio (INR) <=1.5 and Partial Thromboplastin Time (PTT) <=5m over ULN. 9. postmenopausal, or eligible for highly effective contraceptive methods. 10. if a woman of childbearing age, a negative serum pregnancy test is required prior to randomisation to group. 11.Participants have provided signed informed consent and are willing to comply with study-specific procedures and protocol schedules and examinations.
Exclusion criteria
Exclusion criteria: 1. patients who are currently or have previously undergone 2 or more systemic antineoplastic treatment regimens for hepatocellular carcinoma, including cytotoxic drug therapy, targeted drug therapy, and clinical investigational drug therapy; and patients who have participated in, or are participating in, a clinical trial of another drug within 4 weeks prior to enrollment in treatment in this study (prior to randomisation); 2. fibrous platysmal carcinoma or mixed hepatocellular cholangiocarcinoma; 3. coexisting malignancies 4. patients with any active autoimmune disease or history of autoimmune disease including, but not limited to: hepatitis, pneumonia, uveitis, colitis (inflammatory bowel disease), pituitary gland inflammation, vasculitis, hyperthyroidism, and hypothyroidism, unless the patient has vitiligo or resolved childhood asthma/atopic dermatitis. Asthma requiring intermittent use of bronchodilators or other medical interventions should also be excluded; 5. concurrent medical conditions requiring immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids. Use of more than 10 mg/day of prednisone or equivalent is prohibited for 2 weeks prior to administration of study drug; 6. history of known hypersensitivity to any of the components; 7. previous brain metastases, molluscum contagiosum disease or uncontrolled spinal cord compression, central nervous system metastases or hepatic encephalopathy; 8. history or current hepatic encephalopathy or clinically significant ascites; 9. patients with a tumour burden of >=50% of liver volume or who have received a liver transplant; 10. uncontrolled hypertension and cardiovascular disease; 11. proteinuria >= (++) and total urinary protein > 1.0 g in 24 hours; 12. having had any of the following conditions prior to randomisation: (1) Discontinued study treatment from another clinical trial within 28 days prior to randomisation; (2) Has had locoregional hepatic treatment within 28 days prior to randomisation; (3) Major surgery, trauma, unhealed wound or peptic ulcer within 28 days prior to randomisation; (4) Radiation therapy to a non-hepatic area (e.g. bone) within 14 days prior to randomisation; (5) Had a bleeding event considered life-threatening or any grade 3 or 4 gastrointestinal bleeding event requiring intervention within 3 months prior to randomisation; (6) An arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischaemic attack within 6 months prior to randomisation; (7) Gastrointestinal perforation or fistula within 6 months prior to randomisation; 13. placement of a subcutaneous venous access device within 7 days prior to the first administration of the drug, unless the procedure is considered to have a low risk of bleeding; 14. oesophageal or gastric varices requiring intervention or representing a high risk of bleeding; 15. participants with evidence of portal hypertension or previous bleeding must undergo endoscopic evaluation within 3 months prior to randomisation; 16. screening tests positive for HIV antibodies; 17. symptomatic congestive heart failure (New York Heart Association Class II-IV), unstable angina or symptomatic or poorly controlled arrhythmias; 18. any condition that interferes with the subject's ability to swallow medication and any condition that interferes with the absorption or pharmacokinetics of the test medication, including a history of gastrointest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of Response;Progression-free survival ;Overall survival ;Safety; | — |
Countries
China
Contacts
Public ContactWen Zhang
?Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed