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.
Male or female patients aged 18 to 75 years, inclusive.
Eastern Cooperative Oncology Group performance status score of 0 or 1.
Pathologically confirmed hepatocellular carcinoma, based on at least one lesion or previous biopsy confirming hepatocellular carcinoma.
Child-Pugh class A, score 5 to 6, or Child-Pugh class B, score 7 only.
Histologically confirmed combined hepatocellular-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or other non-hepatocellular primary liver malignancy.
Prior yttrium-90 radioembolization.
Hepatitis B viral load greater than 2000 IU/mL despite effective antiviral therapy.
More than 3 discrete hepatic nodules.
Single group
Stereotactic Body Radiation Therapy (SBRT)
RadiationSBRT will be delivered to all tumor lesions at a total dose of 25-50 Gy in 5 fractions, with 5-10 Gy per fraction.
QL1706
DrugQL1706 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.
Objective Response Rate
Objective response rate is defined as the proportion of evaluable participants who achieve confirmed complete response or partial response as assessed by the investigator according to modified RECIST criteria.
Local Control Rate of SBRT Target Lesions
Progression-Free Survival
Overall Survival
Disease Control Rate
change from baseline in serum hepatocellular carcinoma-associated biomarkers
Change from baseline in serum gastrointestinal tumor-associated biomarkers
Change from baseline in immune-related parameters
Correlation between biomarker response and clinical efficacy outcomes
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