Spots Global Cancer Trial Database for A Study of Anlotinib Combined With AK105 Injection in Subjects With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Advanced Solid Tumor
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Trial Identification
Brief Title: A Study of Anlotinib Combined With AK105 Injection in Subjects With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Advanced Solid Tumor
Official Title: A Randomized, Open-label , Multi-cohort, Multicenter, Phase II Study of Anlotinib Combined With AK105 Injection in Subjects With MSI-H or dMMR Advanced Solid Tumor
Study ID: NCT04291248
Conditions
Study Description
Brief Summary: This study is designed to evaluate the efficacy and safety of Anlotinib combined with AK105 injection or AK105 monotherapy in subjects with MSI-H or dMMR advanced solid tumors. In this study, 138 subjects will be enrolled, and those who met the admission criteria will divide into cohort 1 (anlotinib combined with AK105) and cohort 2 (AK105 ). The first phase of this study is a randomized, open-label, parallel-controlled, multicenter design, in which 30 subjects are randomly enrolled in two cohorts. The second phase is to continue enrollment of cohort 1 or cohort 2 when which cohort has the better clinical benefit than the other one.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Hospital, Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, Beijing, China
Peking University International Hospital, Beijing, Beijing, China
The Third Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
The Second Affiliated Hospital of The PLA Air Force Medical University, Xi'an, Shanxi, China
Shanxi Cancer Hospital, Xi'an, Shanxi, China
Tianjin Cancer Hospital, Tianjin, Tianjin, China
Contact Details
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