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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04803851
Other study ID # JS2791
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 12, 2021
Est. completion date June 29, 2024

Study information

Verified date February 2023
Source Peking Union Medical College Hospital
Contact XIANG WANG, Master
Phone 86-1069158773
Email wangxiang5123@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 29
Est. completion date June 29, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - locally advanced or metastatic pancreatic cancer (PC), - histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma, - failed to second-line chemotherapy for PC, - 18-75 years of age, - an Eastern Cooperative Oncology Group performance status score of 0 to 1, - adequate organ functions Exclusion Criteria: - had received PD 1 /CTLA 4 antibody treatment - had received anti-VEGFR inhibitors or antibodies

Study Design


Intervention

Drug:
Anlotinib plus AK105
Anlotinib: a multi-kinase inhibitor AK105: an anti-PD-1 antibody

Locations

Country Name City State
China Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Objective response rate (ORR) based on RECIST V. 1.1 Objective response rate (ORR) based on RECIST V. 1.1 by investigators 6 weeks
Secondary 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
Secondary 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
Secondary 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
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