BCLC Stage 0–B Hepatocellular Carcinoma
Conditions
Interventions
Observation group:None
Sponsors
Affiliated Hospital of Yanbian University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be signed prior to any trial-related procedures; 2. Male or female, aged >=18 years; 3. Hepatocellular carcinoma (HCC) confirmed by imaging or histopathology; 4. Barcelona Clinic Liver Cancer (BCLC) stage 0–B; 5. Patients who previously underwent surgical resection or curative ablation, with recurrence occurring more than 2 years after the initial treatment; 6. No vascular invasion or extrahepatic metastasis; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; 8. Estimated life expectancy >6 months; 9. Adequate organ function, defined as meeting the following laboratory criteria: Absolute neutrophil count (ANC) >=1.5 × 10^9/L without granulocyte colony-stimulating factor use within 14 days prior to testing; Platelet count >=75 × 10^9/L without transfusion within 14 days; Hemoglobin >9 g/dL without blood transfusion or erythropoietin within 14 days; Total bilirubin =50 mL/min; International normalized ratio (INR) <=2.3 or prothrombin time (PT) <=6 seconds above the upper limit of normal; Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the reference range; if baseline TSH is outside the normal range, patients may still be eligible if total T3 (or FT3) and FT4 are within normal limits; Normal cardiac enzyme levels (patients with isolated, clinically insignificant laboratory abnormalities as judged by the investigator may be enrolled). 10. For women of childbearing potential, a negative urine or serum pregnancy test within 3 days prior to the first study drug administration (Cycle 1 Day 1) is required. If the urine pregnancy test result is equivocal, a serum test must be performed. Women of non-childbearing potential are defined as those who are postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy; 11. All participants (male and female) with reproductive potential must agree to use highly effective contraception (with an annual failure rate <1%) throughout the study period and for at least 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).
Exclusion criteria
Exclusion criteria: 1.Known combined hepatocellular-cholangiocarcinoma, sarcomatoid HCC, mixed HCC, or fibrolamellar carcinoma; presence of another active malignancy within the past 5 years or concurrently, except for adequately treated localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast; 2. Patients who undergo more than one ablation after enrollment (note: a second salvage ablation is permitted if performed within 4 weeks after the first ablation); 3. Patients who receive more than one transarterial chemoembolization (TACE) procedure after enrollment; 4. Evidence of residual disease, recurrence, or metastasis at randomization; 5. Prior therapy with anti–PD-1, anti–PD-L1, anti–PD-L2 antibodies, or agents targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137); 6. Systemic treatment with traditional Chinese medicines with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin) within 2 weeks prior to first dose; 7. Symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage, or Child–Pugh score >2 (patients with imaging evidence of small-volume ascites without clinical symptoms may be enrolled); uncontrolled or moderate-to-severe pleural effusion or pericardial effusion; 8. History of hepatic encephalopathy; 9. Active autoimmune disease or history of autoimmune disease that may relapse (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [patients controlled on hormone replacement therapy may be included]); patients with stable, non–systemically treated skin conditions such as vitiligo, psoriasis, alopecia, controlled type I diabetes mellitus on insulin therapy, or childhood asthma completely resolved without adult intervention may be enrolled; patients with asthma requiring bronchodilator therapy are excluded; 10. Current interstitial pneumonia or interstitial lung disease, history of steroid-requiring interstitial pneumonia or ILD, or other lung conditions that may interfere with the assessment and management of immune-related pneumonitis (e.g., pulmonary fibrosis, organizing pneumonia such as bronchiolitis obliterans, pneumoconiosis, drug-induced pneumonitis, idiopathic pneumonia); evidence of active pneumonia on screening CT or severely impaired pulmonary function; active tuberculosis; prior radiation pneumonitis is permitted if confined to the radiation field; 11. Known allergy to the active ingredient or excipients of toripalimab; 12. Known history of human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive); 13. Untreated active hepatitis B infection, defined as HBsAg-positive with HBV DNA above the upper limit of normal (ULN) for the testing laboratory. Patients may be eligible if they meet the following criteria: HBV DNA <1000 copies/mL (200 IU/mL) prior to first dose, with antiviral therapy administered throughout chemotherapy to prevent reactivation; For anti-HBc(+), HBsAg(–), anti-HBs(–), and HBV DNA(–) patients, prophylactic antiviral therapy is not required, but close monitoring for viral reactivation is necessary. 14. Active hepatitis C infection, defined as HCV antibody positive with HCV RNA above the lower limit of detection; 15. Pregnant or breastfeeding women; 16. Presence of any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival.OS;Local Tumor Progression,LTP;Intrahepatic Distant Recurrence,IDR;Time to Extrahepatic Dissemination,TTED;Adverse Events,AEs; | — |
Countries
China
Contacts
Public ContactSongnan Zhang
Affiliated Hospital of Yanbian University
Outcome results
None listed