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

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT07179900
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QL1706 — DRUG
    Apololitovoreli monoclonal antibody (QL1706) 7.5mg/kg intravenous infusion, once every 3 weeks
  • Radiotherapy — RADIATION
    41.4-50.4Gy/1.8Gy/23-28F
  • Sintilimab — DRUG
    200mg q3w
  • Bevacizumab — DRUG
    15mg/kg q3w

Study Details

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.

Key Dates

First listed
Sep 18, 2025
Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Other: 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.

Primary Outcome Measure

Objective response rate [ Time Frame: 1 year ]

Central Contacts

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