RecruitingPhase 2NCT07179900

Radiotherapy Combined With QL1706 and Bevacizumab for Unresectable Non-metastatic Hepatocellular Carcinoma

Exploration of Radiotherapy Combined With QL1706 and Bevacizumab for the Conversion Treatment of Unresectable Non-metastatic Hepatocellular Carcinoma: A Prospective, Open-label, Randomized Controlled Clinical Study


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

60 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This project is a prospective, open-label, randomized controlled clinical study. It plans to enroll 60 patients with unresectable HCC and no distant metastasis, randomly assigned to the experimental group and the control group, with 30 cases in each group. The experimental group was treated with radiotherapy combined with immunotherapy and Bevacizumab, while the control group was treated with immunotherapy and Bevacizumab. The efficacy of the patients and the conversion rate to surgery were evaluated.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Age ≥ 18 years old, gender not limited; PS score 0-2; Pathologically or clinically diagnosed as primary HCC and has not received other anti-HCC treatment; No history of other malignant tumors or treatment; Patients with BCLC stage B or C before treatment and no distant metastasis, and surgical assessment indicates that first-line surgical resection is not feasible; Liver function grade Child-Pugh A or B ≤ 7 points; For patients with active HBV infection, antiviral treatment should be initiated at least 7 days before treatment and they should agree to continue antiviral treatment during the study period; No severe cardiovascular or cerebrovascular diseases; Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the treatment period and 6 months after treatment; if the serum or urine pregnancy test is negative within 14 days before inclusion in the study, and the patient must be non-lactating; men should agree to take contraceptive measures during the study period and 6 months after the study; Voluntarily sign the written informed consent form and commit to comply with the protocol during the study period, including accepting treatment and scheduled visits and examinations, including follow-up; The expected survival must be at least 12 weeks.

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Interventions

DRUGQL1706

Apololitovoreli monoclonal antibody (QL1706) 7.5mg/kg intravenous infusion, once every 3 weeks

RADIATIONRadiotherapy

41.4-50.4Gy/1.8Gy/23-28F

DRUGSintilimab

200mg q3w

DRUGBevacizumab

15mg/kg q3w


Locations(1)

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

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NCT07179900


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