Hepatocellular carcinoma
Conditions
Interventions
Single-arm:Anlotinib Hydrochloride Capsules Combined With Toripalimab Injection
Sponsors
The Second Affiliated Hospital of Hai'nan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (irRECIST or mRECIST) meet the following criteria: Hepatic lesion (1) The lesion can be accurately measured in at least one dimension as >=1.0 centimeter (cm) (viable tumor for typical; and longest diameter for atypical), and (2) The lesion is suitable for repeat measurement. Nonhepatic lesion (3) Lymph node (LN) lesion that measures at least one dimension as >=1.5 cm in the short axis, except for porta hepatis LN that measures >=2.0 cm in the short axis; (4) Non-nodal lesion that measures >=1.0 cm in the longest diameter Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion. 2. Aged 18 to 75 years; 3. ECOG performance status of 0-1; 4. No prior treatment for advanced HCC disease; 5. Liver function status Child-Pugh Class A or B (score 1.5x10^9/L, platelets count =/> 100x10^9/L, HGB =/> 90 g/L; (2) total bilirubin =/< 1.5 UNL; SGOT and SGPT =/< 2.5 UNL (=/< 5 UNL in patients with liver metastases); (3) Creatinine =/< 1.5 UNL; 9. HBV-DNA<2000IU/mL and HBsAg-positive patients must receive antiviral treatment in accordance with the 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B; 10. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma; 3. Participants who have received any systemic chemotherapy, targeted therapy, immunity therapy or any systemic investigational anticancer agents, including Chinese medicine antitumor drugs, for advanced/unresectable HCC; 4. Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg), patients with myocardial infarction, arrhythmias with poor control (including QTC interval > 450 ms) and cardiac insufficiency of grade II according to NYHA standard; 5. with bleeding tendency or undergoing thrombolysis or anticoagulation therapy; 6. serious uncontrolled intercurrence infection; 7. Proteinuria >=2+ (1.0g/24hr); 8. Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness. 9. Within 6 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.; 10. Have a history of mental illness or psychotropic drug abuse; 11. Patients with a history of immunodeficiency(or autoimmue disease), or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and hematopoietic stem cell transplantation; 12. Patients who are allergic to components of toripalimab Injection and anlotinib preparations; 13. According to the researchers' judgment, there are serious concomitant diseases that endanger patient safety or prevent patients from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DoR;DCR;OS;Safety; | — |
Countries
China
Contacts
Public ContactHaifeng Lin
The Second Affiliated Hospital of Hai'nan Medical University
Outcome results
None listed