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SBRT Combined With Iparomlimab and Tuvonralimab (QL1706) and Bevacizumab for Hepatocellular Carcinoma
Sponsor: Peking University Cancer Hospital & Institute
Summary
SBRT combined with dual PD-1/CTLA-4 blockade (iparomlimab and tuvonralimab, QL1706) and bevacizumab may provide complementary local and systemic antitumor activity in hepatocellular carcinoma (HCC). This prospective, single-arm, single-center study evaluates the efficacy and safety of stereotactic body radiotherapy (SBRT) to all intra- and extrahepatic lesions combined with QL1706 (7.5 mg/kg intravenously on day 1 every 3 weeks) and bevacizumab (15 mg/kg intravenously on day 1 every 3 weeks) in patients with inoperable locally advanced or oligometastatic HCC (BCLC stage B or C). All lesions receive SBRT at 8 Gy in 3-5 fractions completed within 30 days; systemic therapy starts within 1 week before or after the start of radiotherapy and continues as maintenance for up to 2 years, until progression, death, or unacceptable toxicity. The primary endpoint is objective response rate per RECIST 1.1. Secondary endpoints include complete response, disease control rate, time to response, duration of response, local control, progression-free survival, time to progression, and overall survival per RECIST 1.1 and mRECIST, safety per CTCAE v6.0, and quality of life per EORTC QLQ-C30 and QLQ-HCC18. A total of 33 patients will be enrolled at Beijing Cancer Hospital.
Official title: Effectiveness and Safety of Stereotactic Body Radiotherapy Combined With Iparomlimab and Tuvonralimab and Bevacizumab in Patients With Locally Advanced or Oligometastatic Hepatocellular Carcinoma: A Prospective, Single-Arm, Single-Center Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2026-10-15
Completion Date
2031-08
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Stereotactic Body Radiotherapy
SBRT to all intra- and extrahepatic lesions. Prescription dose 8 Gy x 3-5 fractions, with the fraction number determined by lesion location and proximity to organs at risk; one fraction per day or every other day on weekdays; interfraction interval 24-72 hours; the entire course completed within 30 days; image-guided radiotherapy at every fraction.
Bevacizumab
Bevacizumab injection. 15 mg/kg intravenous infusion on day 1 of each 21-day cycle, on the same schedule as QL1706, continued as maintenance until 2 years of cumulative treatment, disease progression, death, or unacceptable toxicity.
Iparomlimab and Tuvonralimab
QL1706 (commercial name Qibeian), a bifunctional anti-PD-1/CTLA-4 combination antibody. 7.5 mg/kg intravenous infusion on day 1 of each 21-day cycle, starting within 1 week before or after the start of SBRT and continued as maintenance until 2 years of cumulative treatment, disease progression, death, or unacceptable toxicity.
Locations (1)
Beijing Cancer Hospital
Beijing, China