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Brief Title: A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma
Official Title: A Multicenter, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Gastric Carcinoma
Study ID: NCT04718402
Brief Summary: This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma.
Detailed Description: This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma. At least 30 subjects will be recruited in this study. The subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2 by an intravenous infusion (IV), every 21 days (q3w, 1 cycle). All patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator or patient decision (a maximum of 8 cycles).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Luhe Hospital Capital Medical University, Beijing, Beijing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Lanzhou University Second Hospital, Lanzhou, Gansu, China
Hebei General Hospital, Shijiazhuang, Hebei, China
The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital, Shijiazhuang, Hebei, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Cancer Hospital of The University of Chinese Academy of Science, Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China
Name: Jieer Ying, Doctor
Affiliation: Cancer Hospital of The University of Chinese Academy of Science
Role: PRINCIPAL_INVESTIGATOR