Back to resultsAnlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
Primary Purpose
Anlotinib, Anti-PD-1 Antibody, Advanced Pancreatic Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anlotinib plus AK105
Sponsored by
About this trial
This is an interventional treatment trial for Anlotinib
Eligibility Criteria
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
Sites / Locations
- Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Anlotinib plus AK105
Outcomes
Primary Outcome Measures
Disease control rate (DCR) based on RECIST v. 1 1
Disease control rate (DCR) based on RECIST v. 1 1 by investigators
Secondary Outcome Measures
Objective response rate (ORR) based on RECIST V. 1.1
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
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
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
adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Full Information
NCT ID
NCT04803851
First Posted
February 23, 2021
Last Updated
June 18, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04803851
Brief Title
Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
Official Title
Anlotinib Plus Anti-PD-1 Antibody AK105 as Third or More-line Therapy for Advanced Pancreatic Cancer: a Prospective, Single-arm, Open-label, Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
June 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anlotinib, Anti-PD-1 Antibody, Advanced Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Anlotinib plus AK105
Intervention Type
Drug
Intervention Name(s)
Anlotinib plus AK105
Intervention Description
Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody
Primary Outcome Measure Information:
Title
Disease control rate (DCR) based on RECIST v. 1 1
Description
Disease control rate (DCR) based on RECIST v. 1 1 by investigators
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) based on RECIST V. 1.1
Description
Objective response rate (ORR) based on RECIST V. 1.1 by investigators
Time Frame
6 weeks
Title
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression
Description
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression by investigators assessment
Time Frame
6 weeks
Title
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause
Description
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause by investigators assessment
Time Frame
6 weeks
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XIANG WANG, Master
Phone
86-1069158773
Email
wangxiang5123@126.com
Facility Information:
Facility Name
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Wang, Doctor
Phone
011-86-10-69151279
Email
wangxiang5123@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
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