This is a single-arm, phase II clinical study designed to evaluate the efficacy and safety of a recombinant PD-1/IL-2 bispecific antibody, as neoadjuvant therapy in hepatocellular carcinoma (HCC) patients who experienced early recurrence after curative hepatectomy and were suitable for repeat surgical resection.
A total of approximately 30 eligible participants are planned to be enrolled. All patients will receive neoadjuvant treatment with PD-1/IL-2 bispecific antibody for 3 cycles. Curative re-resection will be performed 2 to 7 weeks after the last dose of PD-1/IL-2 bispecific antibody for patients with resectable lesions confirmed by imaging assessment. Tumor evaluation will be conducted per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) throughout the study. Postoperative pathological assessment and long-term follow-up will be implemented after surgery.
The primary endpoint is the major pathological response (MPR) rate. Secondary endpoints include complete pathological response (pCR) rate, event-free survival (EFS), overall survival (OS), R0 resection rate, objective response rate (ORR), disease control rate (DCR), and the safety and tolerability profile . Exploratory endpoints aim to analyze the correlation between biomarkers (e.g., PD-L1 expression, tumor microenvironment) and treatment efficacy.
This study intends to explore the clinical value of PD-1/IL-2 bispecific antibody in the neoadjuvant setting for recurrent resectable HCC, and provide evidence for its clinical application in this patient population.
Have signed the written informed consent form and be able to comply with all scheduled visits and study procedures specified in the protocol.
Aged between 18 and 75 years old (inclusive), with no restriction on gender.
Diagnosed with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology, or meeting the clinical diagnostic criteria for HCC formulated by the American Association for the Study of Liver Diseases (AASLD) or the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer.
Must provide tumor tissue specimens obtained from the initial surgical resection during the screening period.
Histologically or cytologically confirmed diagnosis of tumors containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed carcinoma, and intrahepatic cholangiocarcinoma.
Prior treatment with anti-PD-1/PD-L1 agents or other antitumor immunotherapies.
Presence of unresolved Grade >1 toxicities related to any previous antitumor therapy (persistent Grade 2 alopecia, anemia, peripheral neuropathy, electrolyte abnormalities manageable with treatment, and endocrine disorders well-controlled with hormone replacement therapy are excluded).
History of hepatic encephalopathy or seizures; presence of active, newly diagnosed or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis or leptomeningeal metastases.
Single group
PD-1/IL-2 Bispecific Antibody Fusion Protein
Biological/VaccineA recombinant PD-1/IL-2 bispecific antibody fusion protein that simultaneously blocks the PD-1/PD-L1 pathway and activates the IL-2 signaling pathway. It is administered by intravenous infusion as neoadjuvant therapy prior to curative surgical resection. Patients receive multiple cycles of treatment, starting with a lower priming dose followed by standard doses administered every 2 weeks. After completing neoadjuvant treatment, eligible patients proceed to curative hepatectomy followed by long-term follow-up.
Major Pathological Response Rate (MPR)
Major Pathological Response (MPR) is defined as the proportion of patients with ≤50% residual viable tumor cells in the resected specimen after neoadjuvant treatment,
Complete Pathological Response Rate (pCR)
Defined as the proportion of patients with no residual viable tumor cells found in the completely resected surgical specimen after neoadjuvant treatment,
Event-Free Survival (EFS)
Defined as the time from the first dose to the first occurrence of disease progression that prevents curative resection, post-operative local recurrence, distant metastasis, or death from any cause, whichever occurs first.
Overall Survival (OS)
Defined as the time from the first dose to death from any cause.
R0 Resection Rate
Defined as the proportion of patients achieving complete surgical resection with no residual microscopic tumor at the resection margins,
Correlation Between Biomarkers and Treatment Efficacy
Exploratory assessment of the relationship between biomarkers and treatment efficacy, including but not limited to PD-L1 expression and tumor microenvironment characteristics.
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