Liver Cancer
Conditions
Interventions
Experimental group:Treatment of Icaritin soft capsule combined with ADG106 injection
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, both male and female; 2. HCC patients with stage IIB, IIIa and IIIB according to China liver cancer staging (CNLC), who have received anti-pd1 / L1 drugs, and who are in strict accordance with the clinical diagnostic criteria of the code for diagnosis and treatment of primary liver cancer (2019 Edition) issued by the National Health Commission and / or confirmed by pathological / cytological examination; 3. At least one measurable target lesion (the smallest diameter is 1cm). 4. Hematological examination meets the following standards; Haematology ( no blood transfusion or Blood products or Hematopoietic growth factor within 7 days); Hemoglobin >= 80g / L; Neutrophil cell count >= 1.5 x 10^9 / L; Platelets count >= 50 x 10^9 / L; Clinical chemistry: Albumin >= 28g / L; (no albumin or blood products transfusion within 7 days); ALT and AST <= 5 x Upper limit of normal (ULN); Total bilirubin <= 2.0 x ULN; Serum creatinine <= 1.5 x ULN; 5. The expected survival time was more than 3 months; 6. Child Pugh <= 7; 7. Be able to observe adverse events and curative effect cooperatively; 8. Willing to sign informed consent 9. ECOG score <= 2; 10. The pregnancy test of women of childbearing age was negative.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to any of the components of Icaritin and ADG 106; 2. Patients with recent (within one year) history of embolic disease; 3. Any active autoimmune disease or known history of autoimmune disease or syndrome requiring treatment with systemic steroids or immunosuppressive drugs (except for thyroid diseases controlled by alternative therapy / nonimmunosuppressive therapy); 4. Any uncontrollable clinical problems (such as serious mental, neurological, cardiovascular, respiratory and other system diseases) or active infections that significantly affect clinical trials; 5. Metastasis or invasion of central nervous system or various mental disorders; 6. Patients with active upper gastrointestinal ulcer or other diseases known to affect drug absorption, distribution, metabolism or clearance; 7. Patients with other primary malignant tumors, except those who have been cured for more than 5 years; 8. Severe or uncontrolled active hepatitis B (except HBsAg positive, but HBV DNA is controlled within the normal range of the detection value of the research center) or hepatitis C (except anti HCV antibody positive, but HCV RNA is controlled within the normal range of the detection value of the research center). 9. HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation; 10. Excessive use of Glucocorticoid (> 10mg / D prednisone or equivalent dose) or other immunosuppressants within 4 weeks before the first administration of the study drug; 11. Underwent major surgery (except biopsy) within 4 weeks before admission; 12. Irae of grade 3 or withdrawal due to immunotherapy in the past. Patients with previous hypothyroidism, type 1 diabetes and skin Irae (except for Steven Johnson syndrome, toxic epidermal necrolysis or other severe dermatitis) were enrolled; 13. The patient had active interstitial lung disease (ILD) or pneumonia, and needed hormone or immunosuppressive therapy for ILD or pneumonia; 14. Patients who had been treated with 4-1BB agonist in the past; patients with obvious gastrointestinal bleeding tendency, uncontrolled body cavity effusion, previous treatment toxicity has not recovered, and the previous treatment has not undergone enough washing out period (>= 5 half-life); 15. Patients considered unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;DCR;PFS;TTP;OS;QOL; | — |
Countries
China
Contacts
Public ContactWeihong Zhao
Chinese PLA General Hospital
Outcome results
None listed