The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy
Volunteer to participate in clinical research;To fully understand and understand this study and to sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures
The age of signing ICF is ≥ 18 years old and ≤ 75 years old，regardless of gender;
Hepatocellular carcinoma (HCC) confirmed by histopathology or cytology, or clinically meeting the American Association of Hepatology (AASLD) criteria for HCC diagnosis；
Previous failure or progression of at least one standard systemic therapy for hepatocellular carcinoma (standard therapy refers to PD-1/ L1-based combination therapy, or lenvatinib, sorafenib), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy.
Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known;
History of any second malignant tumor within the first 2 years prior to randomization, excluding early-stage malignancies that have been treated curatively (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, breast ductal carcinoma in situ, and papillary thyroid carcinoma;
History of hepatic encephalopathy or has undergone a liver transplant. Patients who are preparing for or have previously undergone organ or bone marrow transplantation;
Within 6 months prior to randomization, present with portal hypertension accompanied by upper gastrointestinal bleeding, or have esophageal/gastric varices with red wale markings, or are at risk of ruptured hemorrhagic hepatic cancer nodules, or are considered by the researcher to be at high risk of bleeding;
Map coordinates are unavailable for these locations. Locations are shown below instead.
China