Massive hepatocellular carcinoma(Single lesion with a maximum diameter of = 10 cm)
Conditions
Interventions
Stage Ib:Lattice SSFRT+iparomlimab and tuvonralimab + bevacizumab
Stage II:Subjects received a peak dose of PR2D/14F, with combination antibody therapy of Etok (7.5 mg/kg, D1, D5, q3w) and Bevacizumab (15 mg/kg, D5, q3w) until the occurrence of a protocol-defined tr
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily participate in this study and sign the informed consent form; 2.Age: 18 to 75 years old (inclusive), gender not restricted; 3.Unresectable massive hepatocellular carcinoma confirmed by histopathological or cytological diagnosis (with a single lesion diameter >= 10 cm), or unresectable massive HCC that meets the clinical diagnostic criteria specified in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition); 4.ECOG PS 0-2; 5.Child-Pugh A~B; 6.No prior receipt of any anti-tumor treatment for HCC (e.g., surgery, radiotherapy, TACE, ablation, chemotherapy, targeted therapy, immunotherapy, etc.); 7.Patients with BCLC B-C, with tumors confined to one lobe of the liver and accompanied by PVTT graded Vp1–Vp3 (per the Japanese PVTT classification criteria); 8.According to mRECIST v1.1, there are at least two radiologically measurable lesions; 9.For patients positive for HBsAg, HBV-DNA must be = 1.5×10?/L; Hb)>= 85 g/L; PLT)>= 70×10?/L. 2) Adequate liver function, defined as: AST, ALP, and ALT) 40 mL/min, calculated per the Cockcroft-Gault formula. 5) Adequate pancreatic function, defined as: Amylase and Lipase <= 1.5×ULN. 6) Normal thyroid function, defined as: Thyroid Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range are also eligible for enrollment; 11.Adequate control of BP with a maximum of 3 antihypertensive medications, defined as BP <= 150/90 mmHg at screening, and no changes in antihypertensive therapy within 1 week prior to Cycle 1/Day 1. 12.The patient’s expected survival time is more than 3 months; 13.No pregnancy or planned pregnancy.
Exclusion criteria
Exclusion criteria: 1.Pathologically confirmed non-HCC, such as ICC, sarcomatoid HCC, CHC, and FLC; 2.Diffuse HCC with intrahepatic tumor burden >= 50%; 3.Vp4 and hepatic vein tumor thrombus (including superior mesenteric vein tumor thrombus, inferior vena cava tumor thrombus, and right atrial tumor thrombus); 4.Contraindications to radiotherapy; 5.Subjects with known hypersensitivity to the components of bevacizumab; 6.Subjects with known hypersensitivity to the active ingredients or excipients of the iparomlimab and tuvonralimab; 7.Concurrent other malignant tumors; 8.Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to use effective contraceptive measures; 9.Myocardial ischemia of Grade II or higher, myocardial infarction, or poorly controlled arrhythmia (including QTc interval >= 470 ms); cardiac insufficiency of Grade III–IV according to the NYHA classification, or LVEF 1.5, or PT> ULN+4 seconds, or APTT> 1.5 × ULN), bleeding tendency, or current receipt of thrombolytic or anticoagulant therapy. 11.History of mental illness or substance abuse of psychotropic drugs; 12.Patients with HIV infection or syphilis infection that is not effectively controlled; 13.Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 14.Patients with active infections, such as pulmonary infection, gastrointestinal infection, and urinary tract infection; 15.Patients with poor compliance, such as migrant populations; 16.Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another T-cell receptor that is stimulatory or co-inhibitory (e.g., CTLA-4, OX-40, CD137); 17.Active autoimmune disease requiring systemic treatment (e.g., DMARDs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic treatment. 18.Receipt of systemic glucocorticoid therapy within 7 days prior to the first dose of the study (excluding intranasal, inhaled, or topical glucocorticoids via other routes) or any other form of immunosuppressive therapy; Note: Use of physiological doses of glucocorticoids (= 200,000 IU/ml (106 copies/ml); for HCV infection, HCV RNA >= 10³ copies/ml. 21.Vaccination with live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: Administration of inactivated viral vaccines for seasonal influenza via injection is permitted within 30 days prior to the first dose; however, intranasal attenuated live influenza vaccines are not allowed; 22.Subjects deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;Security;OS;Time to disease progression;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhang Jianwen
The affiliated hospital of southwest medical university
Outcome results
None listed