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NOT YET RECRUITING
NCT07882056
PHASE2

SBRT Combined With Iparomlimab and Tuvonralimab (QL1706) and Bevacizumab for Hepatocellular Carcinoma

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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

Interventions

RADIATION

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.

DRUG

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.

DRUG

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