A Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04207463|
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors||Drug: AK105 Drug: Anlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open, Single-arm, Multi-cohort, Multicenter Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors|
|Actual Study Start Date :||June 3, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||May 30, 2021|
Experimental: Anlotinib and AK105 injection
AK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
AK105 is a humanized monoclonal antibody that specifically binds to PD-1. AK105 has a typical antibody structure and is composed of two lgG1 subtype heavy chains and two kappa subtypes light chains covalently linked by disulfide bonds.
a multi-target receptor tyrosine kinase inhibitor
- Overall response rate (ORR) [ Time Frame: up to 96 weeks ]Percentage of subjects achieving complete response (CR) and partial response (PR).
- Disease control rate（DCR） [ Time Frame: up to 96 weeks ]Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
- Duration of Response (DOR) [ Time Frame: up to 96 weeks ]DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
- Progression-free survival (PFS) [ Time Frame: up to 96 weeks ]PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
- Overall survival (OS) [ Time Frame: up to 120 weeks ]OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04207463
|Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Aiping Zhou, Doctor 021-38804518 firstname.lastname@example.org|
|Principal Investigator: Aiping Zhou, Doctor|
|Beijing Hospital||Not yet recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Yunbo Zhao, Doctor 010-85136715|
|Principal Investigator: Yunbo Zhao, Doctor|
|Peking Union Medical College Hospital||Not yet recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Jianfeng Zhou, Doctor 010-69158750|
|Principal Investigator: Jianfeng Zhou, Doctor|
|Jiangsu Cancer Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210009|
|Contact: Jifeng Feng, Doctor 025-83283415|
|Principal Investigator: Jifeng Feng, Doctor|
|Harbin Medical University Cancer Hospital||Not yet recruiting|
|Harbin, Jilin, China, 150081|
|Contact: Yanqiao Zhang, Doctor 0451-86298278|
|Principal Investigator: Yanqiao Zhang, Doctor|
|Jinan Central Hospital||Recruiting|
|Jinan, Shandong, China, 250013|
|Contact: Yuping Sun, Doctor 0531-68623306|
|Principal Investigator: Yuping Sun, Doctor|
|Shanxi Provincial Cancer Hospital||Not yet recruiting|
|Xi'an, Shanxi, China, 710061|
|Contact: Zijun Liao, Doctor 029-85276142|
|Principal Investigator: Zijun Liao, Doctor|