EICHORCondition: Hepatocellular Carcinoma Non-Resectable · Sponsor: Nanfang Hospital, Southern Medical University
The objective of this clinical trial study is to determine whether intravenous chemotherapy with the Ralox regimen in combination with Anlotinib and Penpulimab has certain efficacy and high safety for patients with unresectable hepatocellular carcinoma. Overall design: This clinical study is a single - center, single - arm, prospective clinical study. In this single - arm study, randomization grouping is not involved. Sample size estimation: According to previous research reports, the objective response rate (ORR0) of targeted immunotherapy for literature unresectable HCC is 30%. If α = 0.05 and 1 - β = 0.80 are set, and assuming that the ORR1 of systemic chemotherapy combined with targeted immunotherapy for unresectable HCC is 59.2%, at least 21 patients need to be enrolled as calculated by the PASS15.0 software. Considering a 10% dropout rate, 24 patients need to be enrolled. It is planned to enroll a total of 30 patients. Subjects will receive systemic intravenous chemotherapy combined with immune checkpoint inhibitors and targeted drug therapy: The intravenous chemotherapy regimen is as follows: Oxaliplatin 100 mg/m², intravenous infusion for 3 hours on Day 1, once every 3 weeks; Raltitrexed 3 mg/m², intravenous infusion for 15 minutes on Day 1. Penpulimab 200 mg, once every 3 weeks. Anlotinib 12 mg, taken orally once a day, with 2 weeks of administration followed by 1 week of discontinuation. Each cycle is 21 days. The combined medication will be continued for 3 cy…
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| Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong, China | — |
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Source record: clinicaltrials.gov/study/NCT07746960