Radiotherapy Combined With QL1706 and Bevacizumab for Unresectable Non-metastatic Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT07179900
- Lead Sponsor
- Hebei Medical University Fourth Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
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Age ≥ 18 years old, gender not limited;
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PS score 0-2;
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Pathologically or clinically diagnosed as primary HCC and has not received other anti-HCC treatment;
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No history of other malignant tumors or treatment;
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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;
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Liver function grade Child-Pugh A or B ≤ 7 points;
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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; ⑧ No severe cardiovascular or cerebrovascular diseases;
⑨ Important organ functions should meet the following requirements: absolute neutrophil count (ANC) ≥ 1.0×10^9/L; platelet count ≥ 50×10^9/L; hemoglobin ≥ 9g/dL; serum creatinine (SCR) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml/min (Cockcroft Gault formula); total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); AST or ALT level ≤ 2.5 times the upper limit of normal (ULN); urine protein < 2+, if urine protein ≥ 2+, then 24-hour urine protein quantification must be ≤ g. Normal coagulation function, no active bleeding or thrombotic diseases: 1). International normalized ratio INR ≤ 1.5×ULN; 2). Partial thromboplastin time APTT ≤ 1.5×ULN; 3). Prothrombin time PT ≤ 1.5×ULN;
⑩ 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;
⑪ 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;
⑫ The expected survival must be at least 12 weeks.
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Patients who do not meet the above main inclusion criteria;
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Patients who refuse to sign the informed consent form;
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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; ④ 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;
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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; ⑦ Patients whom the investigator deems unsuitable for participation in this study.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiotherapy+QL1706+Bevacizumab QL1706 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. Radiotherapy+QL1706+Bevacizumab Radiotherapy 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. Radiotherapy+QL1706+Bevacizumab 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. Sintilimab+Bevacizumab Sintilimab 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. Sintilimab+Bevacizumab 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 Measures
Name Time Method Objective response rate 1 year PR+CR
R0 resection rate 1 year The proportion of patients achieving R0 resection
- Secondary Outcome Measures
Name Time Method PFS 3 year The time from randomization to disease progression (PD) or death from any cause
OS 3 year The time from randomization to patient death due to various reasons.
The occurrence of treatment-related adverse events 3 Year Treatment-related adverse events were evaluated and statistically summarized according to CTCAE version 5.0.
pCR rate 1 year The proportion of patients achieving pCR in postoperative pathology
Time of disease progression 3 year The time from the start of treatment to disease progression (PD)