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NOT YET RECRUITING
NCT07668570
PHASE4

SBRT Plus QL1706 as Second-Line Therapy for Hepatocellular Carcinoma

Sponsor: Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, single-center exploratory clinical study designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with QL1706 in patients with hepatocellular carcinoma who have received one prior line of systemic therapy and experienced radiographic disease progression or intolerance. Eligible patients will receive SBRT to all evaluable intrahepatic lesions at a total dose of 25-50 Gy delivered in 5 fractions. Within 7-14 days after completion of SBRT, patients will receive QL1706 at 7.5 mg/kg by intravenous infusion every 3 weeks. Treatment with QL1706 will continue until confirmed disease progression, intolerable toxicity, patient request to withdraw, withdrawal of informed consent, or other protocol-defined treatment discontinuation criteria, whichever occurs first. The primary endpoint is objective response rate assessed by the investigator according to modified RECIST criteria. Secondary endpoints include local control rate of SBRT target lesions, progression-free survival, overall survival, disease control rate, and the incidence of adverse events and serious adverse events. Exploratory endpoints include dynamic changes in serum tumor biomarkers and immune-related indicators, as well as their association with clinical outcomes. A total of 36 patients are planned for enrollment.

Official title: A Prospective, Single-Arm, Single-Center Exploratory Clinical Study of Stereotactic Body Radiation Therapy Combined With QL1706 in the Second-Line Treatment of Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-07

Completion Date

2030-07

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT will be delivered to all tumor lesions at a total dose of 25-50 Gy in 5 fractions, with 5-10 Gy per fraction.

DRUG

QL1706

QL1706 will be administered at 7.5 mg/kg by intravenous infusion every 3 weeks, starting within 7-14 days after completion of SBRT. Dose interruption or permanent discontinuation may be required based on individual safety and tolerability. Dose escalation or dose reduction is not recommended.