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NCT Number: NCT07179900

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

Patients who do not meet the above main inclusion criteria; Patients who refuse to sign the informed consent form; Patients with pathological types of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma; or those with postoperative pathology suggesting metastatic cancer or primary cancer of other tissue types; Patients with portal hypertension diagnosed by preoperative enhanced abdominal CT and endoscopy, with a history of esophageal variceal bleeding, severe hypersplenism syndrome or refractory ascites; Patients diagnosed with severe active scleroderma, lupus, other rheumatic diseases or autoimmune diseases within the past 3 months before study recruitment; patients with a history of clinically severe autoimmune diseases or those requiring systemic steroids or immunosuppressants will not be allowed to participate in this study; Patients with a history of cognitive dysfunction or mental illness that affects treatment compliance; Patients whom the investigator deems unsuitable for participation in this study.

Treatment and study plan

QL1706

Drug

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

Other names: Iparomlimab and Tuvonralimab Injection

Radiotherapy

Radiation

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

Sintilimab

Drug

200mg q3w

Bevacizumab

Drug

15mg/kg q3w

Primary outcomes

  1. Objective response rate

    Time frame: 1 year

    PR+CR

  2. R0 resection rate

    Time frame: 1 year

    The proportion of patients achieving R0 resection

Secondary outcomes

  1. pCR rate

    Time frame: 1 year

    The proportion of patients achieving pCR in postoperative pathology

  2. Time of disease progression

    Time frame: 3 year

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

  3. PFS

    Time frame: 3 year

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

  4. OS

    Time frame: 3 year

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

  5. The occurrence of treatment-related adverse events

    Time frame: 3 Year

    Treatment-related adverse events were evaluated and statistically summarized according to CTCAE version 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Fengpeng Wu

CONTACT

[email protected]

86-031186296771

Linlin Xiao

CONTACT

[email protected]

86-031186296771

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 18, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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