hepatocellular carcinoma
Conditions
Interventions
treatment group:sintilimab combined with lenvatinib
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. HCC confirmed by histology / cytology or cirrhosis meeting the clinical diagnostic criteria of American Association for the study of liver diseases (AASLD). 2. Aged >= 18 years, males or females. 3. ECOG Performance Status of 0 or 1. 4. Advanced or unresectable or metastatic HCC patients (BCLC stage B-C stage), not suitable for local therapy or progressed after local treatments. 5. Received at least one systemic chemotherapy (including chemotherapy with oxaliplatin or arsenite injection) and / or failed or intolerable of sorafenib treatment. 6. At least one measurable disease (according to RECIST v1.1). a) Liver lesions: at least one repeatable measurement, diameter >= 1.0 cm; b) Non-liver lesions: lymph node lesion with a single diameter of short axis >= 1.5 cm; non lymph node lesion with the longest diameter >= 1.0 cm. Lesions previously treated by radiotherapy or local area treatment must have imaging evidence of disease progression before they can be regarded as target diseases 7. Child Pugh score = 3.0 x 10^9 / L, neutrophil absolute value >= 1.5 x 10^9 / L, platelet count >= 85 x 10^9 / L, hemoglobin >= 85g / L; b) Total bilirubin = 28 g / L (no albumin transfusion within 2 weeks; only one of albumin and bilirubin can be point of 2 in child Pugh score, otherwise the score is >7), Serum creatinine = 12 weeks. 10. For women or men whose sexual partners are women of childbearing potential, contraceptive measures shall be taken during the whole treatment period and 6 months after the last dose administration. 11. Signed Informed Consent Form and be able to comply with the study protocol and visit plan.
Exclusion criteria
Exclusion criteria: 1. Received any targeted treatment (including sorafenib) within 2 weeks; systemic anti-cancer treatment (including chemotherapy, biological immunotherapy, hormone therapy, anti-tumor Chinese medicine treatment, etc.) in addition to the targeted treatment and any local treatment (including but not limited to small surgery, percutaneous ethanol injection, radiofrequency ablation, transcatheter Arterial (chemotherapy) embolization or radiotherapy] within 4 weeks before the first dose administration; or received any blood regulation therapy (including blood transfusion, blood products or drugs that stimulate blood cell production, such as granulocyte colony stimulating factor G-CSF) within 2 weeks before the first administration. 2. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 3. History of hepatic encephalopathy or liver transplantation. 4. Clinically significant ascites. 5. For patients with active HBV or HCV: HBV DNA>2000IU/ml or 104 copies /mL; HCV RNA>\103 copies /mL; both HbsAg and HCV positive. 6. With central nervous system metastasis 7. Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months. Severe varices (G3) are known to be present on endoscopy within 3 months prior to the first administration; portal hypertension (including splenomegaly found by imaging); high bleeding risk in the investigator's judgment. 8. Any life-threatening bleeding event, including the need for blood transfusion, surgery or local treatment or continuous drug treatment in the past 3 months. 9. Thromboembolic events in the past 6 months including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism (except thrombus of implanted vein port or catheter source or superficial vein after routine anticoagulant treatment) Prophylactic use of low-molecular-weight heparin (e.g., enoxaparin 40 mg / day) is permitted. 10. portal venous tumor thrombosis, or involvement of the superior mesenteric vein; Inferior Vena Cava Tumor Thrombosi 11. Recent (within 2 weeks before first dose administration) use of aspirin (>325 mg/day) for more than 10 days continuously or other drugs inhibiting platelet aggregation like dipyridamole or clopidogrel. 12. Inadequately controlled arterial hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic BP >100 mmHg), history of hypertensive crisis or hypertensive encephalopathy. 13. Symptomatic congestive heart failure, Grade 3 or 4Symptomatic or poorly controlled arrhythmias, history of congenital long QT syndrome, corrected QTc > 500ms (calculated by friderica method). 14. Evidence of bleeding diathesis or significant coagulopathy, or current use of thrombolytic agents for therapeutic. 15. With a history of gastrointestinal perforation and / or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea. 16. Radiotherapy within 3 weeks before the first dose administration. Otherwise, all the following conditions must be met before entering the group: no toxic reaction related to radiotherapy, no need to take glucocorticoids, and no radiation pneumonia, radiation hepatitis, radiation enteritis,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free rate (PFR); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;DCR;DOR;TTP;PFR;OS;OSR; | — |
Countries
China
Contacts
Public ContactLijun Wang
Beijing Cancer Hospital
Outcome results
None listed