Spots Global Cancer Trial Database for A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients
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Trial Identification
Brief Title: A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients
Study ID: NCT06092606
Study Description
Brief Summary: Purpose：1. Preliminary evaluation of the preventive effect of DH001 on doxorubicin-induced cardiotoxicity in cancer patients 2.To explore appropriate dosages to provide basis for dosages in subsequent confirmatory studies 3.To evaluate the effect of DH001 on the efficacy of doxorubicin treatment in cancer patients 4.To evaluate the safety of DH001 in cancer patients treated with doxorubicin
Detailed Description: After the subjects sign the informed consent form, meet the inclusion criteria and do not meet the exclusion criteria, they will receive a random number according to the order of enrollment, and will be randomly assigned to the DH001 low-dose group (200 mg), DH001 high-dose group (400 mg) and control group in a 1:1:1 manner according to the randomization plan；Stratification factor: Patient's tumor type \[lymphoma and non-lymphoma (breast cancer, soft tissue sarcoma, etc.)\].
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Harbin Institute of Hematology and Cancer, Harbin, Heilongjiang, China
Contact Details
Name: Jun Zhu
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Hongmei Jing
Affiliation: Peking University Third Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Hui Zhou
Affiliation: Hunan Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Yufu Li
Affiliation: Henan Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Hesheng He
Affiliation: The First Affilaited Hospital of Wannan Medical College
Role: PRINCIPAL_INVESTIGATOR
Name: Zeping Zhou
Affiliation: The Second Affiliated Hospital of Kunming Medical University
Role: PRINCIPAL_INVESTIGATOR
Name: Wenbin Qian
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaojia Wang
Affiliation: Zhejiang Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jiwei Liu
Affiliation: The First Affiliated Hospital of Dalian Medical University
Role: PRINCIPAL_INVESTIGATOR
Name: Zhenchang Sun
Affiliation: The First Affiliated Hospital of Zhengzhou University
Role: PRINCIPAL_INVESTIGATOR
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