HCC - Hepatocellular CarcinomaPhase 4NCT07668570
SBRT Plus QL1706 as Second-Line Therapy for Hepatocellular Carcinoma
A Phase 4 study testing Stereotactic Body Radiation Therapy (SBRT) and QL1706 in people with HCC - Hepatocellular Carcinoma, run by Hebei Medical University Fourth Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and QL1706
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 1500/mm^3.
- Platelet count at least 75 × 10^9/L or greater than 75,000/mm^3.
- Serum bilirubin no more than 1.5 times the institutional upper limit of normal.
- Aspartate aminotransferase and alanine aminotransferase no more than 2.5 times the institutional upper limit of normal.
- Creatinine clearance greater than 45 mL/min, measured directly, calculated by the Cockcroft-Gault formula, or measured by 24-hour urine collection.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test before the first dose of study treatment.
- Male or female patients of reproductive potential must agree to use adequate contraception from the first dose of study treatment until 180 days after the last dose of study treatment.
- Life expectancy of more than 6 months, as assessed by the investigator.
- Able to understand and comply with study requirements and voluntarily sign the informed consent form.
Who cannot join
- 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.
- Presence of extrahepatic metastasis or M1 disease.
- Current participation in another study with investigational treatment, or participation in an investigational drug or device study within 4 weeks before the first dose of study treatment.
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- Immunodeficiency disease, or use of systemic corticosteroids at a daily dose greater than 10 mg prednisone or equivalent on the day of the first dose of study treatment or within 14 days before the first dose of study treatment.
- Active tuberculosis, or inadequately treated latent tuberculosis infection with a high risk of recurrence in the investigator's judgment.
- Hypersensitivity to recombinant humanized anti-PD-1 or anti-PD-L1 monoclonal antibodies, recombinant humanized anti-CTLA-4 monoclonal antibodies, or any of their components.
- Receipt of anticancer therapy within 4 weeks before Day 1 of study treatment, or failure of toxicities from prior therapy to recover to Grade 1 or lower or to baseline level.
- Other progressive malignancy requiring active treatment.
- Autoimmune disease requiring systemic treatment within the past 2 years, including immunomodulators, corticosteroids, or immunosuppressants. Replacement therapy such as thyroxine, insulin, or physiologic hormone replacement for adrenal or pituitary insufficiency is not considered systemic treatment. Prior organ transplantation, including liver transplantation.
- History or evidence of active non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Psychiatric illness or history of substance abuse that may interfere with study compliance.
- Receipt of a live vaccine within 30 days before the planned initiation of study treatment.
- Planned pregnancy or breastfeeding.
- Any medical history, treatment, or laboratory abnormality that, in the investigator's judgment, may interfere with study results, affect full participation in the study, or not be in the patient's best interest.
About this study
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
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.
Read the detailed description
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.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), QL1706
- Keywords
- Hepatocellular carcinoma, second-line, SBRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called SBRT, Stereotactic Ablative Radiotherapy
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.
QL1706Drug
Also called Iparomlimab and Tuvonralimab Injection
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.
| Study group | Role | What they receive |
|---|---|---|
| SBRT Followed by QL1706 | Experimental | Participants will receive SBRT to intrahepatic tumor lesions at a total dose of 25-50 Gy in 5 fractions, with 5-10 Gy per fraction. Within 7-14 days after completion of SBRT, participants will receive QL1706 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. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Secondary outcomes (5)
Local Control Rate of SBRT Target Lesions
Measured: up to 24 months
Progression-Free Survival
Measured: up to 24 months
Overall Survival
Measured: up to 24 months
Disease Control Rate
Measured: up to 24 months
Incidence of Adverse Events and Serious Adverse Events
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668570
- Sponsor's protocol ID
- 2026KY010
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study is a single-center exploratory clinical study with a limited sample size, and individual participant-level data may contain sensitive clinical information. De-identified aggregate study results may be published or presented in scientific meetings where appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07668570
- Acronym / sponsor ID
- 2026KY010
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, second-line, SBRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT Followed by QL1706 | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Drug: QL1706Participants will receive SBRT to intrahepatic tumor lesions at a total dose of 25-50 Gy in 5 fractions, with 5-10 Gy per fraction. Within 7-14 days after completion of SBRT, participants will receive QL1706 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
- Presence of extrahepatic metastasis or M1 disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Also: SBRT, Stereotactic Ablative RadiotherapySBRT will be delivered to all tumor lesions at a total dose of 25-50 Gy in 5 fractions, with 5-10 Gy per fraction. | Radiation | SBRT Followed by QL1706 |
| QL1706Also: Iparomlimab and Tuvonralimab InjectionQL1706 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. | Drug | SBRT Followed by QL1706 |
Primary outcome
Objective Response Rate
Time frame: up to 24 months
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study is a single-center exploratory clinical study with a limited sample size, and individual participant-level data may contain sensitive clinical information. De-identified aggregate study results may be published or presented in scientific meetings where appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stereotactic Body Radiation Therapy (SBRT) and QL1706 in people with HCC - Hepatocellular Carcinoma, run by Hebei Medical University Fourth Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.