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PD-1/IL-2 Bispecific Antibody as Neoadjuvant Therapy for Early Recurrent Hepatocellular Carcinoma After Curative Hepatectomy

NCT07644208 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-12

No results posted yet for this study

Summary

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.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

BIOLOGICAL

PD-1/IL-2 Bispecific Antibody Fusion Protein

A 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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Jian Zhou · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-06-01
Completion
2029-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07644208 on ClinicalTrials.gov