SBRT Plus QL1706 as Second-Line Therapy for Hepatocellular Carcinoma

NCT07668570 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026KY010
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hepatocellular carcinoma; second-line; SBRT

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 months

Secondary Outcomes (5)

• Local Control Rate of SBRT Target Lesions

  up to 24 months

• Progression-Free Survival

  up to 24 months

• Overall Survival

  up to 24 months

• Disease Control Rate

  up to 24 months

• Incidence of Adverse Events and Serious Adverse Events

  up to 24 months

Other Outcomes (4)

• change from baseline in serum hepatocellular carcinoma-associated biomarkers

  up to 24 months

• Change from baseline in serum gastrointestinal tumor-associated biomarkers

  up to 24 months

• Change from baseline in immune-related parameters

  up to 24 months

Study Arms (1)

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.

Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: QL1706

Interventions

QL1706 DRUG

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.

Also known as: Iparomlimab and Tuvonralimab Injection

SBRT Followed by QL1706

Stereotactic Body Radiation Therapy (SBRT) RADIATION

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.

Also known as: SBRT, Stereotactic Ablative Radiotherapy

SBRT Followed by QL1706

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1500/mm\^3.
• Platelet count at least 75 × 10\^9/L or greater than 75,000/mm\^3.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 25, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share