Status:
NOT_YET_RECRUITING
Radiotherapy Combined With QL1706 and Bevacizumab for Unresectable Non-metastatic Hepatocellular Carcinoma
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 g...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07179900
Start Date
December 1 2025
End Date
October 1 2028
Last Update
December 11 2025
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