Hepatocellular Carcinoma
Conditions
Interventions
experimental group:Teriprizumab injection + Lenvatinib
Sponsors
Department of Hepatobiliary Surgery, Affiliated Cancer Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years (inclusive), male or female. 2. HCC patients who meet the diagnostic criteria of the diagnostic and therapeutic criteria for primary liver cancer (2019 Edition). 3. Patients with stage B (intermediate stage) or stage C (advanced stage) according to Barcelona clinical liver cancer stage (BCLC stage) and any of the following conditions:Not suitable for surgery and / or local treatment; disease progression after surgery and / or local treatment. 4. Patients who have not received any systemic therapy for HCC in the past (mainly including systemic chemotherapy, anti angiogenic drugs or other molecular targeted therapy, immunotherapy containing CTLA-4 and PD-1 / PD-L1 monoclonal antibody). 5. According to RECIST v1.1, patients with more than one measurable lesion. Requirements: the selected target lesion has not received local treatment before, or the selected target lesion is located in the previous local treatment area, but it is later confirmed as Pd by imaging examination and recistv1.1 standard. 6. Patients with child Pugh liver function grade A or B =1.5 x 10^9 / L; platelet count >= 75 x 10^9 / L; hemoglobin >= 90 g / L; serum albumin >= 29 g / L; total bilirubin = 50 ml / min (calculated by Cockcroft Gault formula); international normalized ratio (INR) = 2 +, 24-hour (H) urinary protein quantitation should be performed, and those with 24-hour urinary protein quantitation < 1.0 g can be included in the group). 10. If HBsAg (+) and / or HBcAb (+), HBV DNA must be less than 1000 IU / ml, and continue to receive the original anti HBV treatment during the whole study period, or start to use entecavir or tenofovir after screening. 11. Women of childbearing age must have serum pregnancy test within 7 days before enrollment, and the result is negative, and they agree to use reliable and effective contraceptive methods during the test period and within 60 days after the last administration. For male subjects whose partners are women of childbearing age, they must agree to use reliable and effective contraceptive methods during the trial period and within 60 days after the last administration. 12. The patients who voluntarily participated in the study should fully informed consent and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with known cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and hepatic fibrolamellar carcinoma. 2. Patients who have suffered from malignant tumors other than HCC within 5 years, except for the local tumors that have been cured, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ. 3. Patients who had received liver surgery and / or local treatment or experimental drug treatment for HCC within 4 weeks before enrollment; patients who had received palliative radiotherapy for bone metastases within 2 weeks before enrollment; patients who had received traditional Chinese medicine preparation with anti hepatoma effect within 2 weeks before enrollment. The toxicity caused by previous treatment (except alopecia) did not return to = 3 (nci-ctcae V5.0) gastrointestinal or non gastrointestinal fistulas. 8. According to CT / MRI examination, the patients with tumor thrombus invasion (more than 1 / 2 of the lumen) in the main portal vein (VP4), inferior vena cava tumor thrombus or heart involvement. 9. Patients with severe cardiovascular and cerebrovascular diseases: congestive heart failure, unstable angina pectoris, myocardial infarction, cerebrovascular accident, stroke or poorly controlled arrhythmia of NYHA class II or above within 12 months before enrollment. Left ventricular ejection fraction (LVEF) was less than 50%. The corrected QT interval (QTC) was more than 480 MS (calculated by fridericia method, if the QTc was abnormal, it could be detected three times at an interval of 2 minutes, and the average value was taken). Drug refractory hypertension (systolic blood pressure >= 150 mmHg and / or diastolic blood pressure >= 100 mmHg) (based on the mean of >= 2 measurements). Hypertensive crisis or hypertensive encephalopathy occurred in the past. 10. Evidence of other obvious bleeding tendency or major coagulation disorder: (1) Clinically significant hemoptysis or tumor bleeding of any cause occurred within 2 weeks before enrollment; (2) Thrombosis or embolism occurred within 6 months before enrollment; (3) Anticoagulant therapy (except low molecular weight heparin) was used for the purpose of treatment within 2 weeks before admission; (4) Antiplatelet therapy is needed. 11. Patients who had undergone large and medium-sized surgery within 4 weeks before enrollment, excluding diagnostic biopsy. 12. Patients with central nervous system metastasis should be excluded by MRI scan of brain and / or spinal cord if suspected. 13. Patients with severe unhe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Time-To-Progression;Duration of relief;Progression-free survival; | — |
Countries
China
Contacts
Public ContactXiang Bangde
Affiliated Cancer Hospital of Guangxi Medical University
Outcome results
None listed