SBRT Plus QL1706 as Second-Line Therapy for Hepatocellular Carcinoma (NCT07668570) | Clinical Trial Compass
Not Yet RecruitingPhase 4
SBRT Plus QL1706 as Second-Line Therapy for Hepatocellular Carcinoma
36 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Barcelona Clinic Liver Cancer stage C or earlier.
* Not suitable for curative treatment such as surgical resection or liver transplantation, or refusal of curative treatment such as surgical resection or liver transplantation after first-line therapy.
* At least one measurable lesion confirmed by the investigator according to modified RECIST.
* All intrahepatic tumor lesions must be considered suitable for stereotactic body radiation therapy by the investigator.
* At least 700 cc of normal liver volume must be preserved, with a mean radiation dose to this volume of no more than 15 Gy.
* Received one prior line of systemic therapy and experienced radiographic disease progression or intolerance.
* Prior local treatment, such as transarterial chemoembolization, hepatic arterial infusion chemotherapy, or radiofrequency ablation, is allowed if the interval between the prior local treatment and initiation of study treatment is at least 28 days.
* Adequate organ and bone marrow function, defined as all of the following:
* Hemoglobin at least 9.0 g/dL.
* Absolute neutrophil count at least 1.5 × 10\^9/L or greater than 15…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.