Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Korábbi kezelés

• Prior targeted therapy, immunotherapy, radiotherapy, systemic chemotherapy, or other anticancer treatment.
• Currently receiving chronic systemic immunotherapy or hormonal therapy other than physiologic replacement therapy.
• Any unstable systemic disease, including active infection; uncontrolled severe hypertension; unstable angina; new-onset angina within the previous 3 months; congestive heart failure of NYHA class II or higher; myocardial infarction within the previous 6 months; severe cardiac arrhythmia requiring medication; gastrointestinal bleeding within the previous 1 month; or active bleeding tendency.
• Concurrent other malignancy that has not been cured, except carcinoma in situ at another site.
• Other contraindications to radiotherapy or targeted/immunotherapy.

Más betegség

• Severe dysfunction of major organs, including the heart, liver, or kidneys.
• Known hypersensitivity or allergic reaction to any component of the study treatment.
• History of organ transplantation or autologous/allogeneic stem cell transplantation.
• Evidence of acute or active hepatitis B or hepatitis C infection, including HBV-DNA >2,000 IU/mL or HCV-RNA >1,000 copies/mL.
• Any other unfavorable medical or psychiatric condition that, in the investigator's judgment, may affect protocol compliance or evaluation of study endpoints and makes the participant unsuitable for the study.

Laborértékek

• Any disease, metabolic disorder, physical examination finding, or laboratory abnormality that, in the investigator's judgment, suggests a contraindication to the study treatment or a high risk of treatment-related complications.

Egyéb

• ECOG performance status ≥2.
• Child-Pugh score ≥8.
• Pregnancy or breastfeeding.
• Lack of legal capacity or limited legal capacity.
• Any participant considered unsuitable for enrollment by the investigator.

• Age ≥18 and ≤75 years at the time of signing informed consent.
• Histologically or clinically confirmed hepatocellular carcinoma (HCC) according to the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer.
• Radiologically confirmed portal vein tumor thrombus (PVTT), classified as Cheng type I-IV.
• No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy.
• Child-Pugh class A or B with a Child-Pugh score ≤7.
• Considered unsuitable for curative surgery or liver transplantation after multidisciplinary evaluation, but suitable for radiotherapy.
• Adequate organ function, including: WBC ≥3.0 × 10⁹/L; PLT ≥50 × 10⁹/L; hemoglobin ≥80 g/L; ALT ≤5 × ULN; AST ≤5 × ULN; total bilirubin ≤3 × ULN; albumin ≥28 g/L; and creatinine clearance ≥80 mL/min.
• At least one measurable lesion according to mRECIST.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy >3 months.
• No history of abdominal radiotherapy.
• Women of childbearing potential must use effective contraception beginning at least 1 month before screening and throughout the study until the protocol-specified period after study completion.
• Willing and able to comply with study follow-up until death, study completion, or study termination.