Health TrialsbyHealthPanel

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

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHebei Medical University Fourth Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Radiotherapy+QL1706+BevacizumabExperimental treatment 3 interventions
Group B: Sintilimab+BevacizumabOther 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate

PR+CR

Time frame
1 year
2

R0 resection rate

The proportion of patients achieving R0 resection

Time frame
1 year

Secondary outcomes

1

pCR rate

The proportion of patients achieving pCR in postoperative pathology

Time frame
1 year
2

Time of disease progression

The time from the start of treatment to disease progression (PD)

Time frame
3 year
3

PFS

The time from randomization to disease progression (PD) or death from any cause

Time frame
3 year
4

OS

The time from randomization to patient death due to various reasons.

Time frame
3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hebei Medical University Fourth Hospital

Lead sponsor

Source ClinicalTrials.gov
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