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

NCT ID: NCT07179900

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-10-31

Brief 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy+QL1706+Bevacizumab

After enrollment, patients first received radiotherapy (41.4 - 50.4 Gy/23 - 28 F). At 25.2 Gy/14 F of radiotherapy, the first systemic treatment was administered: QL1706 7.5 mg/kg + bevacizumab 15 mg/kg, once every 3 weeks. The second cycle of systemic treatment was initiated 7 - 14 days after the completion of radiotherapy. Within 2 weeks after the completion of 4 cycles of systemic treatment (including 1 cycle during radiotherapy and 3 cycles after radiotherapy), preoperative efficacy was evaluated based on the two primary endpoints of this study.

Group Type: EXPERIMENTAL

QL1706

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

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

Bevacizumab

Intervention Type: DRUG

15mg/kg q3w

Sintilimab+Bevacizumab

After enrollment, patients were received 4 cycles of sintilimab 200mg and bevacizumab 15mg/kg, once every 3 weeks. The first efficacy assessment was conducted within 2 weeks after the end of the systemic treatment, based on the two primary endpoints of this study.

Group Type: OTHER

Sintilimab

Intervention Type: DRUG

200mg q3w

Bevacizumab

Intervention Type: DRUG

15mg/kg q3w

Interventions

QL1706

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

Intervention Type: DRUG

Radiotherapy

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

Intervention Type: RADIATION

Sintilimab

200mg q3w

Intervention Type: DRUG

Bevacizumab

15mg/kg q3w

Intervention Type: DRUG

Other Intervention Names

Iparomlimab and Tuvonralimab Injection

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Fengpeng Wu

Role: CONTACT

wfpzhj@126.com

86-031186296771

Linlin Xiao

Role: CONTACT

drxiaolinlin@163.com

86-031186296771

Other Identifiers

2025KY047

Identifier Type: -

Identifier Source: org_study_id