Hepatocellular Carcinoma
Conditions
Interventions
cohort 1 line:TACE+ Camrelizumab (200mg,d1,Q3W,2 years)+ Apatinib (250mg,qd)
cohort 2 line:TACE+ Camrelizumab (200mg,d1,Q3W,2 years)+ Apatinib (250mg,qd)
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this study and sign an informed consent form 2. Age =18 years old, no gender limit 3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging 4. CNLC stage IIb/IIIa/IIIb or BCLC stage B/C 5. Previous systematic therapy of =1 line 6. At least one measurable lesion according to the mRECIST. 7. Child-Pugh score: A-B grade (=9 points) 8. ECOG PS score: 0-1 points 9. Expected survival time = 3 months; 10. Laboratory test values within 14 days before enrollment meet the following requirements: (1) Routine blood tests: (except hemoglobin, no blood transfusion, no granulocyte colony-stimulating factor [G-CSF], no drug correction within 2 weeks prior to screening) : neutrophil absolute count >= 1.5 x 10^9/L; Platelet >= 75 x 10^9/L; Hemoglobin >= 90 g/L; (2) Biochemical examination: serum albumin >= 30g/L; Serum total bilirubin 50 ml/min; (3) International Standardized ratio (INR) = 2+, 24 hours (h) urine protein quantification, 24 hours (h) urine protein quantification = 2000 IU/mL, antiviral therapy (only nucleosides such as entecavir, tenofovir fumarate, and propofotenofovir fumarate tablets were allowed) was administered for at least 1 week prior to enrollment, and the number of viral copies decreased by more than 10 times (1 lg) compared with that before treatment. For those infected with HBV, antiviral therapy was required throughout the study period. Hepatitis C virus (HCV) -RNA positive subjects must receive antiviral therapy according to treatment guidelines; 12. Fertile women: must agree to abstain from sex (abstain from heterosexual intercourse) or use a reliable and effective method of contraception for at least 120 days from the signing of the informed consent form until the final administration of the study drug. Serum HCG test must be negative within 72 hours before enrollment. And it must be non-lactation; A woman is considered fertile if she has menstruated, has not yet reached postmenopausal status (no menstruation for >= 12 months, no cause other than menopause is found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral ovariectomy); 13. For male subjects with fertile partners, they must agree to abstain from sex or use a reliable and effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Male subjects also had to agree not to donate sperm during the same time period. Male subjects with a pregnant partner are required to use condoms and do not need to use other methods of contraception.
Exclusion criteria
Exclusion criteria: 1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time; 2. Currently accompanied by interstitial pneumonia or interstitial lung disease; 3. Existence of active autoimmune disease or history of autoimmune disease and may relapse; 4. Patients with active infection, unexplained fever >= 38.5? within 1 week before randomization, or baseline white blood cell count >15 x 10^9/L; 5. Patients with congenital or acquired immune deficiencies (such as HIV-infected persons); 6. Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients; 7. Immunosuppressive drugs or systemic hormone therapy were administered within the first 2 weeks of enrollment for immunosuppressive purposes (dose > 10mg/ day prednisone or other therapeutic hormone); 8. There were clinically significant bleeding symptoms or definite bleeding tendency within 6 months before enrollment; 9. Known hereditary or acquired bleeding (e.g., cocoagulation disorder) or thrombotic tendencies; 10. Arterial thromboembolism events occurred within 6 months before enrollment; 11. Clinical symptoms or diseases of the heart that are not well controlled; 12. Have hypertension that is not well controlled by antihypertensive medications (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg); 13. Major vascular disease (e.g., aortic aneurysms requiring surgical repair or recent peripheral artery thrombosis) during the first 6 months of enrollment; 14. severe, unhealed or dehiscence wounds and active ulceration or untreated fractures; 15. Received major surgery within 4 weeks prior to enrollment (except for diagnosis) or expected major surgery during the study period; 16. Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption; 17. Had intestinal obstruction and/or had clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to enrollment; 18. Continued to use strong CYP3A4 inducer within 2 weeks before enrollment or continued to use strong CYP3A4 inhibitor within 1 week before enrollment; 19. Participating in clinical studies of other drugs in the first 4 weeks of enrollment; 20. Pregnant or lactating women; 21. Other factors deemed unsuitable for the study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free surviva; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactGuowen Yin
Jiangsu Cancer Hospital
Outcome results
None listed