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.
This is a prospective, single-arm, single-center exploratory clinical study designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by QL1706 in patients with hepatocellular carcinoma who require second-line treatment after one prior line of systemic therapy. Patients with hepatocellular carcinoma who have received one prior line of systemic therapy and have experienced radiographic disease progression or intolerance may be enrolled if they meet all eligibility criteria. Eligible participants must have at least one measurable lesion according to modified RECIST, and all intrahepatic tumor lesions must be considered suitable for SBRT by the investigator. Patients with extrahepatic metastasis are not eligible. All enrolled participants will receive SBRT to intrahepatic tumor lesions. SBRT will be delivered at a total dose of 25-50 Gy in 5 fractions, with 5-10 Gy per fraction. Radiation treatment planning will ensure that at least 700 cc of normal liver volume is preserved, with a mean radiation dose to this volume of no more than 15 Gy. Within 7-14 days after completion of SBRT, participants will receive QL1706 at 7.5 mg/kg by intravenous infusion once every 3 weeks. QL1706 treatment will continue until confirmed disease progression, intolerable toxicity, patient request to withdraw, withdrawal of informed consent, initiation of new anticancer therapy, or other protocol-defined discontinuation criteria, whichever occurs first. Dose interruption or permanent discontinuation may be required based on individual safety and tolerability. Dose escalation or dose reduction is not recommended. Tumor assessments will be performed at baseline, after completion of SBRT and before the first cycle of QL1706, and every 2 treatment cycles thereafter during study treatment. After treatment discontinuation, follow-up assessments, including survival follow-up, will be performed every 3 months where applicable. The primary outcome measure is objective response rate assessed by the investigator according to modified RECIST. Secondary outcome measures 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 outcome measures include dynamic changes in serum tumor biomarkers and immune-related indicators, and their association with clinical outcomes. Approximately 36 participants are planned to be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
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.
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.
Time frame: up to 24 months
Local Control Rate of SBRT Target Lesions
Time frame: up to 24 months
Progression-Free Survival
Time frame: up to 24 months
Overall Survival
Time frame: up to 24 months
Disease Control Rate
Time frame: up to 24 months
Incidence of Adverse Events and Serious Adverse Events
Time frame: up to 24 months
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