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Lenvatinib combined toripalimab in advanced hepatocellular carcinoma

Eligibility to participate


Inclusion criteria: - The subjects volunteer to participate in the study and agree to sign the informed consent form with good compliance and follow-up. - When signing the declaration of consent, the test persons are at least 18 years old and have no gender limit. - Imaging (according to AASLD or standard for diagnosis and treatment of primary liver cancer 2017 in China) or histopathologically or cytologically confirmed advanced hepatocellular carcinoma. - BCLC stage B or C. Disease is unsuitable for radical surgery and / or topical surgery Treatment or disease progression occurs after surgery and / or local treatment. - Subjects who have received initial systemic treatment (targeted therapies other than lenvatinib, chemotherapy, biological immunotherapy, etc.) other than toripalimab and lenvatinib may be involved. - At least one measurable lesion (according to RECIST version 1.1): the measurable The lesion has a long diameter ≥ 10 mm or the lymphadenopathy has a short diameter ≥ 15 mm Spiral CT scan. - The ECOG value is 0-1 within a week before enrollment. - Liver function assessment: Child-Pugh Grade A (5-6 points). - Estimated survival time ≥ 3 months. - 10. Patients with HBV infection: HBV DNA <2000 IU / ml or <10 ^ 4 copies / ml and received anti-HBV therapy for at least 14 days prior to enrollment in the study, patients with HCV- RNA (+) must receive antiviral therapy; - Hematology and organ function are sufficient within 14 days prior to treatment for this study based on the following laboratory results: - Examination of whole blood cells (no blood transfusion within 14 days, no use of G-CSF and no drug use): WBC ≥ 3.0 × 10 9 / L, Hb ≥ 85 g / L, ANC ≥ 1.5 × 10 9 / L, PLT ≥ 75 × 10 9 / L. - Biochemical examination (no ALB infused within 14 days): ALB ≥ 29 g / l , ALP and ALT and AST <5 × ULN, TBIL ≤ 3 × ULN, creatinine ≤ 1.5 × ULN or CCr> 50 ml / min (standard Cockcroft-Gault formula): female: CrCl = ((140 years) × body weight (kg) × 0.85) / 72 × serum creatinine (mg / dl); Male: CrCl = ((140 years) × body weight (kg) × 1.00) / 72 × serum creatinine (mg / dl) - Agree to abstain from sex (avoid heterosexual intercourse) or use contraceptive methods with one Annual contraceptive failure rate of less than 1% during treatment and for at least 6 months after the last administration. Exclusion criteria: - Patients with hepatocellular carcinoma with any of the following diseases: Suitable for radical diseases surgery; or without evaluation lesion after radical surgery; or liver transplant history or ready for a liver transplant; - ECOG score ≥ 2 points. - Previously treated with lenvatinib or toripalimab. - History of hepatic encephalopathy. - Histopathological results show hepatobiliary carcinoma, sarcomatoid liver cancer, mixed cell carcinoma and stratified cell carcinoma. - It is already known to be allergic or intolerant to recombinant humanized monoclonal PD-1 antibody (or components) or lenvatinib. - Pregnant women (positive pregnancy test before taking the drug) or breastfeeding women. - Received topical treatment, including but not limited to surgery, radiation therapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection, within 4 weeks of the study. - Previous or existing Grade 3 (CTCAE5.0) and higher gastrointestinal fistula or non-gastrointestinal fistula (such as skin). - Factors affecting lenvatinib use, such as inability to swallow, chronic diarrhea, intestinal obstruction, or other conditions that significantly affect drug uptake and absorption. - Ascites with clinical symptoms that require abdominal puncture or drainage therapy, or Child-Pugh score> 2. - Surgery within 4 weeks or minor surgery (simple resection or biopsy) within 7 days prior to the study, patients must be given the first medication to be examined. - Severe cardiovascular and cerebrovascular diseases including but not limited to acute myocardial infarction, severe / unstable angina, cerebrovascular accident or transient ischemic attack, heart failure and arrhythmias within 6 months of enrollment. - Indications of liver and kidney dysfunction: jaundice, ascites and / or bilirubin ≥ 3 × ULN, and / or proteinuria ≥ 3 degrees (CTC-AE 5.0) (> 3.5 g / 24 hours) or kidney failure require blood dialysis or peritoneal dialysis and / or urine test shows urine protein ≥ ++ or 24 hours urine protein> 1.0 g. - Persistent infection> CTCAE 5.0). - thromboembolism (including stroke and / or transient ischemic attack) within 12 years months. - Hypertension that cannot be controlled well with antihypertensive drugs (systolic) (blood pressure> 160 mmHg, diastolic blood pressure> 100 mmHg). - Already known active metastasis of the central nervous system and / or cancerous meningitis. - Active autoimmune disease or autoimmune disease within two years. - Known metastases of the central nervous system and / or cancerous meningitis. - Prepared for or previously received an organ or allogeneic bone marrow transplant - A history of active tuberculosis such as Mycobacterium tuberculosis. - Gastrointestinal bleeding in the last 6 months or tendency to gastrointestinal bleeding Bleeding such as esophageal varices, local active ulceration lesions, feces occult blood ≥ (++) (gastroscopy is required if there is occult blood in the stool (+)) . - History of human immunodeficiency virus infection. - History of hepatitis B virus or hepatitis C virus infection and not receiving regular treatment. - Severe non-healing wounds, ulcers, or fractures. - For other malignant tumors, within 5 years. - Past and current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia and severe impairment of lung function. - received effective treatment with CYP3A4 inhibitors within 7 days prior to the study or received a potent CYP3A4 inducer within 12 days prior to the study. - For active malignant tumors other than hepatocellular carcinoma, within 5 years or at the same time. - Patients are not eligible to participate in this research after extensive investigation. The researchers' assessment. - Patients are participating in another clinical study at the same time .



Minimum age:

18 years

Maximum age:

N / A

Healthy volunteers: