NCT04803851

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2024

Completed
Last Updated

June 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

February 23, 2021

Last Update Submit

June 18, 2023

Conditions

AnlotinibAnti-PD-1 AntibodyAdvanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Objective response rate (ORR) based on RECIST V. 1.1

    6 weeks

  • Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression

    6 weeks

  • Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause

    6 weeks

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    6 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

Anlotinib plus AK105

Drug: Anlotinib plus AK105

Interventions

Anlotinib plus AK105DRUG

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

Treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • locally advanced or metastatic pancreatic cancer (PC),
  • histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma,
  • failed to second-line chemotherapy for PC,
  • years of age,
  • an Eastern Cooperative Oncology Group performance status score of 0 to 1,
  • adequate organ functions

You may not qualify if:

  • had received PD 1 /CTLA 4 antibody treatment
  • had received anti-VEGFR inhibitors or antibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Interventions

anlotinib

Central Study Contacts

XIANG WANG, Master

CONTACT

86-1069158773wangxiang5123@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 18, 2021

Study Start

May 12, 2021

Primary Completion

February 28, 2024

Study Completion

June 29, 2024

Last Updated

June 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)