Hepatocellular Carcinoma
Conditions
Interventions
Experimental Group:Epacadostat and Tislelizumab?TACE?Regorafenib
Sponsors
The First Affiliated Hospital of Henan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance; 2.Males or females aged 18 to 75 years (inclusive); 3.Histologically/cytologically confirmed hepatocellular carcinoma (HCC), or meeting the clinical diagnostic criteria per the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition). 4.Barcelona Clinic Liver Cancer (BCLC) Stage B or C; 5.No prior systemic therapy for HCC; 6.Child-Pugh score = 12 weeks; 10.If active HBV or HCV infection is present, the following criteria must be met: For HBV-infected subjects (HBsAg positive or HBV-DNA positive): Must have received guideline-recommended antiviral therapy for at least 3 days prior to the first dose, with a demonstrated decrease in HBV-DNA. Must continue standard antiviral therapy throughout the study. For HCV-infected subjects (HCVAb positive or HCV RNA positive): Must be in a stable condition per investigator's judgment. If receiving antiviral therapy, it should be continued during the study. 11.Adequate organ function within 7 days prior to treatment initiation, defined as: a. Hemoglobin (Hb) >= 90 g/L. b. White blood cell count >= 3.5 × 10^9/L. c. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L. d. Platelet count (PLT) >= 75 × 10^9/L. e. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) = 40 mL/min; Urinalysis shows urine protein = 2+, a 24-hour urine collection must demonstrate 24-hour urine protein < 1 g; 12.Subjects of childbearing potential must agree to practice abstinence or use highly effective contraception from the time of signing the informed consent form until at least 90 days after the last dose of the study drug(s);
Exclusion criteria
Exclusion criteria: 1.History of allergy to QL1706, regorafenib, TACE-related chemotherapeutic agents, or embolic agents. 2.Prior systemic therapy for HCC (including but not limited to PD-1, PD-L1, or CTLA-4 inhibitors). 3.Diagnosis of a malignancy other than HCC, except for: (1) cured localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast; (2) malignancies treated with curative intent with no evidence of disease recurrence for >=5 years; 4.Diffusely distributed tumor lesions; 5.Planned or prior organ or allogeneic bone marrow transplantation; 6.Tumor thrombus involving the inferior vena cava (IVC) or superior mesenteric vein (SMV); 7.History of hepatic encephalopathy or hepatorenal syndrome; 8.Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage; 9.Contraindications to immune checkpoint inhibitors, targeted agents, or TACE. 10.Presence of central nervous system (CNS) metastases; 11.History of severe psychiatric illness; 12.Severe comorbidities, including significant cardiac, pulmonary, renal, or coagulation dysfunction, or significant cardiovascular disease (e.g., unstable arrhythmia, unstable angina, myocardial infarction). 13.Pregnant or lactating women, or subjects of childbearing potential unwilling or unable to use effective contraception; 14.Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption); 15.Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption); 16.Active or potentially recurrent autoimmune disease; 17.Use of systemic immunosuppressive drugs within 2 weeks prior to enrollment or anticipated need during the study, except for: (1) intranasal, inhaled, topical, or local injection (e.g., intra-articular) corticosteroids; (2) systemic corticosteroids at doses 2); poorly controlled or pacemaker-requiring arrhythmias; uncontrolled hypertension (systolic BP >=140 mmHg and/or diastolic BP >=90 mmHg). 22.Past or current interstitial lung disease, pneumoconiosis, radiation pneumonitis deemed clinically significant by the investigator, or severely impaired lung function that may interfere with the detection or management of suspected drug-related pulmonary toxicity. 23.HIV-positive status. 24.Active tuberculosis; 25.Concurrent enrollment in another interventional clinical study (enrollment in observational/non-interventional studies is permitted). 26.Any condition th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival period;Disease control rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactDaokun Yang
The First Affiliated Hospital of Henan Medical University
Outcome results
None listed