hepatocellular carcinoma
Conditions
Interventions
Experimental group: TACE combined with Adabelimab and lenvatinib mesylate
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Voluntarily participate in this study and sign an informed consent form; Age =18 years old, no gender restrictions; Hepatocellular carcinoma diagnosed by pathological histology, cytology, or imaging; Subjects with CNLC stage IIb/IIIa/IIIb or BCLC stage B/C hepatocellular carcinoma; No prior systemic treatment for hepatocellular carcinoma, or only one line of systemic treatment/surgical resection for hepatocellular carcinoma in the past, with PD/SD and a gap of =4 weeks from the first administration; No prior TACE treatment, or patients who have received TACE with a gap of =4 weeks (except for TACE-resistant patients); Child-Pugh liver function rating: A~B grade (= 9 points); ECOG PS score: 0~1 points; Women of childbearing age must have a negative pregnancy test (ßHCG) before the first dose. Women of childbearing age and men (who have sexual relations with women of childbearing age) must agree to use contraception during the treatment period and within 6 months after the last administration.
Exclusion criteria
Exclusion criteria: Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma (with more than 30% ICC component), and fibrolamellar carcinoma; other active malignant tumors within 5 years or concurrently with HCC; subjects assessed by the investigator as needing surgery combined with radiofrequency ablation treatment before enrollment. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be enrolled; Currently with interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other conditions that may interfere with the judgment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with active pneumonia or severely impaired lung function shown on chest CT during the screening period; active tuberculosis; Presence of active autoimmune disease or a history of autoimmune disease that may recur [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects who can be controlled with hormone replacement therapy only can be enrolled)]; subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma in childhood that has completely resolved and does not require any intervention in adulthood can be enrolled; asthma patients requiring bronchodilators for medical intervention cannot be enrolled; Use of immunosuppressants or systemic corticosteroid treatment for immunosuppression within 2 weeks before enrollment (dose >10mg/day prednisone or other equivalent efficacy steroids); Patients with active infection, unexplained fever =38.5°C within 1 week before enrollment, or baseline white blood cell count >15×10^9/L; administration of therapeutic antibiotics orally or intravenously within 2 weeks before enrollment (except for prophylactic antibiotics administered intravenously for no more than 48 hours); Patients with congenital or acquired immune function defects (such as HIV-infected individuals); Received treatment with live attenuated vaccines within 4 weeks before enrollment, or expected to require such vaccinations during the treatment period or within 60 days after the last administration; Significant clinical bleeding symptoms or clear bleeding tendency within 6 months before enrollment, such as gastrointestinal bleeding, severe esophageal-gastric varices, hemorrhagic gastric ulcer, or patients with vasculitis, etc., if the baseline fecal occult blood test is positive, re-examination can be done, and if still positive after re-examination, a gastroscopy is required; Known genetic or acquired bleeding tendencies (such as coagulation disorders) or thrombotic tendencies, such as hemophilia patients, coagulation mechanism disorders, thrombocytopenia, etc.; currently receiving full-dose oral or injectable anticoagulant or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin is allowed); Arterial thromboembolic events within 6 months before enrollment, such as cerebrovascular accident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS6; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS(overall survival);ORR(Objective Response Rate); | — |
Countries
China
Contacts
Public ContactWeizhong Zhou
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Outcome results
None listed