hepatocellular carcinoma
Conditions
Interventions
Test Group:Adebrelimab+Lenvatinib+Hepatectomy
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years, of either sex 2. The subject meets the diagnostic criteria for primary hepatocellular liver cancer and is surgically resectable as diagnosed by clinical criteria 3. Patients with chinese liver cancer stage (cnlc) ib or iia, i.e. Bclc stage a/b liver cancer patients; 4. Have not received any previous systemic treatment for hepatocellular carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc; 5. At least one imaging measurable lesion according to the solid tumour outcome evaluation criteria (recist 1.1 and mrecist ) 6. An ecog ps score of 0 to 1; 7. A child-pugh liver function rating of a; 8. Hepatitis b virus (hbv) infection, e.g. Hbsag positive, hbv-dna testing and hbv-dna 40 ml/min (calculated by the cockcroft and gault formula) E. Adequate pancreatic function, defined as amylase and lipase = 1.5 x upper limit of normal (uln) F. Normal thyroid function, defined as thyroid stimulating hormone (tsh) within the normal range. If baseline tsh is outside the normal range, subjects with total t3 (or ft3) and ft4 within the normal range may also be enrolled; 11. No pregnancy or pregnancy plans; 12. Subjects voluntarily enrolled in this study, signed an informed consent form, are compliant and cooperative with follow-up.
Exclusion criteria
Exclusion criteria: 1. known to have hepatobiliary ductal carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma, lamellar cell carcinoma and ectopic hepatocellular carcinoma; active malignancies other than HCC within 5 years or concurrently; cured limited tumours such as basal cell carcinoma of the skin, squamous carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix and carcinoma in situ of the breast may be enrolled 2. are prepared to undergo or have previously undergone organ or allogeneic bone marrow transplantation 3. moderate to severe ascites with clinical symptoms; 4. a history of gastrointestinal bleeding or a propensity for gastrointestinal bleeding within 6 months prior to the start of study treatment 5. abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months prior to the start of study treatment 6. a known genetic or acquired propensity to bleeding or thrombosis 7. thrombosis or thromboembolic event within 6 months prior to the start of study treatment 8. poor cardiac clinical signs or disease control; 9. the subject has uncontrollable hypertension (systolic blood pressure = 140 mm Hg or diastolic blood pressure = 90 mm Hg), despite the patient being on optimal drug therapy; the subject has developed hypertensive crisis or hypertensive encephalopathy 10. known hypersensitivity to any component of any investigational drug; known history of severe hypersensitivity reactions to other monoclonal antibodies 11. the patient has developed severe vascular disease within 6 months prior to the start of study treatment 12. patients with severe, unhealed or dehiscent wounds and active ulcers or untreated fractures 13. patients who have undergone major surgical treatment (except for diagnosis) within 4 weeks prior to randomization or who are expected to require major surgical treatment during the study period 14. inability to swallow pills, malabsorption syndrome or any condition affecting gastrointestinal absorption 15. patients with gastrointestinal disorders such as intestinal obstruction (including incomplete intestinal obstruction) or conditions that may cause bleeding, perforation or obstruction of the gastrointestinal tract 16. the presence of evidence of gas in the stomach that cannot be explained by puncture or recent surgery 17. the presence of previous or current central nervous system metastases 18. subjects with a history of hepatic encephalopathy 19. a history of interstitial lung disease and a history of non-infectious pneumonia 20. the patient has any history of active autoimmune disease or anticipated recurrence of autoimmune disease 21. the development of a serious infection within 4 weeks prior to the start of study treatment 22. a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation and bone marrow transplantation 23. continued use of strong CYP3A4 inducers within 2 weeks prior to randomisation or continued use of strong CYP3A4 inhibitors within 1 week prior to randomisation 24. prior treatment with any anti-PD-1/PD-L1 drug or anti-CTLA-4 antibody; 25. subject receiving live attenuated vaccine within 28 days prior to the first dose or expecting to receive the vaccine within 60 days of the final dose or during the study period 26. a known history of psychotropic substance abuse, alcohol and drug abuse 27. concurrent participation in another
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic responses;Pathological complete response;R0 resection rate;Objective response rate;Overall survival;Safety of surgery ;Safety of drug;Tolerance; | — |
Countries
China
Contacts
Public ContactGuang Tan
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed