2021-05-12
2024-02-28
2024-06-29
29
NCT04803851
Peking Union Medical College Hospital
Peking Union Medical College Hospital
INTERVENTIONAL
Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2021-02-23 | N/A | 2023-06-18 |
2021-03-16 | N/A | 2023-06-22 |
2021-03-18 | N/A | 2023-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Treatment group Anlotinib plus AK105 | DRUG: Anlotinib plus AK105
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Disease control rate (DCR) based on RECIST v. 1 1 | Disease control rate (DCR) based on RECIST v. 1 1 by investigators | 6 weeks |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Objective response rate (ORR) based on RECIST V. 1.1 | Objective response rate (ORR) based on RECIST V. 1.1 by investigators | 6 weeks |
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression | Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression by investigators assessment | 6 weeks |
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause | Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause by investigators assessment | 6 weeks |
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). | 6 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: XIANG WANG, Master Phone Number: 86-1069158773 Email: wangxiang5123@126.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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