JDB153 Combined With Penpulimab for Hepatocellular Carcinoma After Standard Treatment Failure

Who cannot join

• History of other malignant tumors with disease-free survival <5 years (except cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors confirmed to be cured by endoscopic mucosal resection);
• Previous treatment with penpulimab;
• Presence of immunodeficiency disease or HIV infection;
• Severe, uncontrolled acute infection (defined as fever >38°C caused by infection); 5. History of active hepatitis B or active hepatitis C, defined as: HBV DNA titer ≥2000 IU/mL (or 1×10⁴ copies/mL) or HCV RNA ≥lower limit of detection; 6. Severe hepatic or renal dysfunction; or recent history of myocardial infarction (within 3 months); 7. Patients with active or previous autoimmune disease that has the potential for recurrence or poses associated risks (e.g., those who have undergone organ transplantation requiring immunosuppressive therapy). However, patients with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, or skin diseases not necessitating systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are permitted to enroll; 8. History of interstitial lung disease or non-infectious pneumonitis that is symptomatic or has a history of pulmonary disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity; 9. History of active tuberculosis infection within 1 year prior to first administration of study drug. However, for patients with a history of active tuberculosis infection more than 1 year ago, enrollment is considered appropriate if the investigator determines there is currently no evidence of active tuberculosis; 10. History of chronic diarrhea or presence of complete intestinal obstruction; 11. Patients requiring systemic treatment with corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drug. Note: Inhaled or topical steroids, or adrenal replacement therapy (≤10 mg/day prednisone equivalent), are permitted in the absence of active autoimmune disease. Short-term (≤7 days) use of corticosteroids for prophylactic treatment (e.g., contrast media allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reactions caused by contact allergens) is permitted; 12. Concurrent other serious medical or surgical conditions affecting organ function that the investigator considers inappropriate for participation in this clinical trial; 13. Participation in other investigational drug clinical trials within 4 weeks; 14. Pregnant or lactating women, or patients with reproductive potential (men or women who have been post-menopausal for less than 1 year) who are unwilling to use adequate contraceptive measures; 15. Patients with a history of allergic or hypersensitivity reactions to any study drug components; 16. Patients deemed inappropriate for participation in this clinical trial by the investigator.