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Brief Title: Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC
Official Title: Efficacy and Safety of Lenvatinib as a Conversion Therapy in Patients With Potentially Resectable Hepatocellular Carcinoma: A Single-Arm and Open-Label Prospective Study
Study ID: NCT04241523
Brief Summary: Lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (HCC). The aim of the single-arm, open-label, phase II clinical trial is to assess efficacy and safety of lenvatinib as a preoperative conversion therapy in patients with potentially resectable HCC. Investigator hypothesized that lenvatinib may be an effective conversion treatment for HCC, and preoperative treatment with lenvatinib can improve resectability in patients with potential resectable HCC and improve the long term survival.
Detailed Description: For patients with potentially resectable HCC (intermediate or advanced stage), upfront therapy with surgical resection is of high recurrence rate after surgery. The aim of the single-arm, open-label, prospective phase II clinical trial is to evaluate whether preoperative lenvatinib treatment could improve resectability and therefore improve the long term survival. Participants who are recruited in this study in this study will be treated with lenvatinib and will be evaluated for the feasibility for surgical resection by a multidisciplinary team every 8 weeks. If the participants underwent curative resection, they will receive lenvatinib treatment for 48 weeks after surgery.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anhui Provincial Hospital, Hefei, Anhui, China
Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
West China Hospital, Chengdu, Sichuan, China
180 Fenglin Road, Shanghai, , China
Name: Jian Zhou
Affiliation: Shanghai Zhongshan Hospital
Role: PRINCIPAL_INVESTIGATOR