PD-1/IL-2 Bispecific Antibody as Neoadjuvant Therapy for Early Recurrent Hepatocellular Carcinoma… (NCT07644208) | Clinical Trial Compass
Not Yet RecruitingPhase 2
PD-1/IL-2 Bispecific Antibody as Neoadjuvant Therapy for Early Recurrent Hepatocellular Carcinoma After Curative Hepatectomy
30 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Have a history of curative hepatectomy for HCC, with pathologically confirmed tumor recurrence occurring 3 months to 2 years after surgery. Candidates shall be assessed by a multidisciplinary team (MDT) and meet all the following criteria for repeat resection:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), and the lesion has not received any local therapy.
. Have adequate organ and bone marrow function. Laboratory test results obtained within 7 days prior to enrollment shall meet the following requirements. No blood products, erythropoietin, colony-stimulating factors, thrombopoietin, albumin or other parenteral corrective medications are allowed within 14 days before laboratory testing:
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Exclusion criteria
. 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.
. Presence of clinically significant cardiovascular and cerebrovascular diseases, including:
. Current or prior history of interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, severe pulmonary dysfunction or other restrictive lung diseases requiring corticosteroids or other treatments.
. History of severe or uncontrolled allergic diathesis, drug allergy, asthma or atopic dermatitis.
. Known allergy to IL-2, sintilimab, other monoclonal antibodies or their excipients.