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Brief Title: A Trial of SHR-1701 in Combination With Famitinib in Patients With Advanced Solid Tumors
Official Title: SHR-1701 Plus Famitinib Malate in Advanced Solid Tumors: An Open-label, Multi-center, Phase I/II Trial
Study ID: NCT04679038
Brief Summary: This is an open-label, multi-center study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with metastatic or locally advanced solid tumor. There are two parts of the study: combinational therapy part and monotherapy part. Phase I of combinational therapy part is to determine the recommended dose for Phase II (RP2D) for famitinib in the combined regimen, then efficacy and safety of SHR-1701 plus famitinib (RP2D) will be further evaluated in the following Phase II in cohorts 1/2/3, with simon's two-stage design. Meanwhile, efficacy and safety of famitinib will also be assessed in cohorts 4/5 in the monotherapy part.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anhui Provincial Hospital, Hefei, Anhui, China
The 2nd Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Beijing Cancer Hospital, Beijing, Beijing, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Hunan Cancer Hospital, Changsha, Hunan, China
General Hospital of Eastern Theater Command, Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical University, Gannan, Jiangxi, China
Jinan Central Hospital, Jinan, Shandong, China
Qingdao Central Hospital, Qingdao, Shandong, China
Huashan Hospital,Fudan University, Shanghai, Shanghai, China
Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China
The 2nd Hospital of Tianjin Medical University, Tianjin, Tianjin, China
The 1st Affiliated Hospital of Zhejiang Medical University, Hangzhou, Zhejiang, China