Hepatocellular Carcinoma
Conditions
Interventions
Experimental Arm:Stereotactic body radiotherapy (SBRT) + IBI310 + Cetuximab
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Informed Consent: Provision of written informed consent prior to the implementation of any study-related procedures. 2. Age: Male or female, aged >=18 years and 3, (3)Multiple tumors (at least one tumor >= 5 cm) involving both lobes of the liver, (4)Presence of factors associated with high postoperative recurrence risk (e.g. direct diaphragmatic invasion). 5. SBRT Eligibility: Candidate deemed suitable for stereotactic body radiotherapy (SBRT). 6. Performance Status: Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0–1. 7. Liver Function: Child–Pugh class A. 8. Portal Hypertension: Absence of portal hypertension or presence of only mild portal hypertension. 9. Prior Therapy: No prior systemic or locoregional therapy for HCC. 10. Adequate Organ Function: Laboratory parameters must meet the following criteria within 14 days prior to enrollment: (1)Hematology: Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L, Platelets (PLT) >= 75 × 10^9/L; Hemoglobin (HGB) >= 9.0 g/dL. (2) Hepatic Function:Total Bilirubin (TBIL) = 35 g/L. (3) Renal Function:Serum Creatinine (Cr) = 50 mL/min (using the Cockcroft-Gault formula), Urinalysis showing urine protein = 2+, a 24-hour urine collection must be performed and the 24-hour urinary protein must be < 1 g. (4)Coagulation Function: International Normalized Ratio (INR) <= 1.5 × ULN. Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN. 11. Contraception and Pregnancy: Women of Childbearing Potential (WOCBP): Must have a negative serum or urine pregnancy test within 3 days prior to the first dose of study drug. If the urine test is positive or inconclusive, a serum pregnancy test is required. Non-childbearing Potential: Defined as postmenopausal for at least 1 year, or surgically sterilized (hysterectomy or bilateral oophorectomy). Contraception Requirement: All patients (male and female) with reproductive potential must agree to use highly effective contraception (failure rate < 1% per year) during the study treatment period and continue for 120 days after the last dose of immunotherapy? (or 180 days after the last dose of chemotherapy, if applicable).
Exclusion criteria
Exclusion criteria: 1. Histological Subtypes: Histologically or cytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed components containing these elements. 2. Concurrent Studies: Currently participating in another interventional clinical study, or having received other investigational drugs or devices within 4 weeks prior to the first dose. 3. Prior Immunotherapy: Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting other stimulatory or co-inhibitory T-cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.). 4. Antitumor TCM: Use of traditional Chinese medicine (TCM) with antitumor indications or immunomodulatory effects (including thymosin, interferon, interleukin; excluding? local intrapleural/intraperitoneal use for effusion control) within 2 weeks prior to the first dose. 5. Autoimmune Disease: History of active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within the past 2 years. Note: Replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroids for adrenal/pituitary insufficiency) are not considered systemic treatment. 6. Systemic Corticosteroids: Receiving systemic corticosteroid therapy (dose > 10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose. Note: Physiologic doses of corticosteroids (= Grade 2, ventricular arrhythmias, or atrial fibrillation). 15. Heart Failure: Unstable angina, congestive heart failure, or chronic heart failure classified as New York Heart Association (NYHA) Functional Classification >= Grade 2. 16. Thromboembolism: History of arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment (e.g., myocardial infarction, unstable angina, cerebrovascular accident [CVA], or transient ischemic attack [TIA]). 17. Hypertension: Uncontrolled hypertension despite antihypertensive therapy. 18. Interstitial Lung Disea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathologic Response ;R0 resection rate;Recurrence-Free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactFeng Shen;Kui Wang;Yong Xia
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed