A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

ConditionsHCC - Hepatocellular Carcinoma Iparomlimab and Tuvonralimab Injection Neoadjuvant Immunotherapy

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).

Eligibility criteria

Qualifiers

Patients voluntarily participate in this study and sign the informed consent form.

Aged 18 to 75 years, male or female.

ECOG Performance Status (PS) score of 0 to 1.

Child-Pugh liver function classification: Grade A.

Disqualifiers

Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapy.

Known hilar cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar carcinoma; other active malignant tumors except HCC within 5 years or concurrently.

Hypertension that cannot be well controlled with antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.

The subject has a history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) or concurrent malignant tumors.

Trial design

Treatments tested in this trial

Iparomlimab and Tuvonralimab

Treatment groups

30 Participants

are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov