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SBRT Plus QL1706 as Second-Line Therapy for Hepatocellular Carcinoma

NCT07668570 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-25

No results posted yet for this study

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.

Conditions

  • HCC - Hepatocellular Carcinoma

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.

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-07-31
Completion
2030-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668570 on ClinicalTrials.gov