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Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer


2021-05-12


2024-02-28


2024-06-29


29

Study Overview

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

  • Anlotinib
  • Anti-PD-1 Antibody
  • Advanced Pancreatic Cancer
  • DRUG: Anlotinib plus AK105
  • JS2791

Study Record Dates

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  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Treatment group

Anlotinib plus AK105

DRUG: Anlotinib plus AK105

  • Anlotinib: a multi-kinase inhibitor AK105: an anti-PD-1 antibody
Primary Outcome MeasuresMeasure DescriptionTime Frame
Disease control rate (DCR) based on RECIST v. 1 1Disease control rate (DCR) based on RECIST v. 1 1 by investigators6 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Objective response rate (ORR) based on RECIST V. 1.1Objective response rate (ORR) based on RECIST V. 1.1 by investigators6 weeks
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progressionProgression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression by investigators assessment6 weeks
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any causeOverall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause by investigators assessment6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).6 weeks

Contacts and Locations

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

Participation Criteria

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:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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