Advanced Pancreatic Cancer, Anlotinib, Anti-PD-1 Antibody
Conditions
Brief 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.
Interventions
DRUGAnlotinib plus AK105
Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) based on RECIST v. 1 1 | 6 weeks | Disease control rate (DCR) based on RECIST v. 1 1 by investigators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) based on RECIST V. 1.1 | 6 weeks | Objective response rate (ORR) based on RECIST V. 1.1 by investigators |
| Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression | 6 weeks | Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression by investigators assessment |
| Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause | 6 weeks | Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause by investigators assessment |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 weeks | adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). |
Countries
China
Contacts
Primary ContactXIANG WANG, Master
Outcome results
None listed