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Recruiting Phase 2 NCT05954897

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

Trial Parameters

Condition Hepatocellular Carcinoma
Sponsor Guangdong Provincial People's Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 29
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-09-01
Completion 2026-01-01
Interventions
Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC

Brief Summary

To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.

Eligibility Criteria

Inclusion Criteria: 1. 18 years or older. 2. HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria. 3. Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system. 4. A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm. 5. No prior treatment for HCC. 6. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). 7. Performance status (PS) ECOG score ≤1. 8. Child-Pugh score ≤7. 9. Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up 10. Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 \^ 9/L; PLT ≥ 75 x 10 \^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AS

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