hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: >18 years old, male or female; 2. Hematocellular carcinoma confirmed by clinical diagnosis; with measurable tumour lesions (spiral CT or MR scan =10mm, meeting RECIST 1.1 criteria) 3. Unresectable hepatocellular carcinoma at CNLC stage Ib-IIIb ( as determined by multi-disciplinary treatment, in accordance with Clinical Practice Guideline for Primary Liver Cancer(2024 Edition)); 4. Child-Pugh A/B 5. No previous systemic anti-tumour therapy (= 6 cycles of neoadjuvant and/or adjuvant therapy allowed for inclusion); 6. Expected survival > 3 months; 7. ECOG PS: 0-2; 8. Women of childbearing potential must undergo a negative pregnancy test (ßHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose; 9. Patients voluntarily enrolled in the study by signing an informed consent form. 10. Patients with complete clinical data, complete follow-up information and regular clinical review.
Exclusion criteria
Exclusion criteria: 1. Concurrent other malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial or non-invasive bladder cancer; 2. Known history of allergy to any of the study drugs; 3. Autoimmune disease and requiring hormonal therapy above 10 mg prednisone/day (or equivalent dose). 4. Active pulmonary infection; 5. History of live attenuated vaccination within 28 days prior to the first study dose or expected live attenuated vaccination during the study period; 6. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 7. Previous allogeneic bone marrow transplantation or solid organ transplantation or preparation for such transplantation; 8. Uncontrolled hypertension, class III-IV cardiac insufficiency (NYHA criteria); 9. Active bleeding, active ulcers, intestinal perforation, intestinal obstruction, within 30 days of major surgery; previous history of definite neurological or psychiatric disorders, including epilepsy or dementia, and known history of psychotropic substance abuse, alcoholism, or drug addiction in the subject; 10. Subjects who, in the opinion of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-Free-Survival;Overall survival;Adverse events; | — |
Countries
China
Contacts
The Sixth People’s Hospital of Shenyang