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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04803851

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anlotinib Anti-PD-1 Antibody Advanced Pancreatic Cancer	Drug: Anlotinib plus AK105	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Anlotinib plus AK105	Drug: Anlotinib plus AK105 Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody

Arm

Intervention/Treatment

Experimental: Treatment group

Anlotinib plus AK105

Drug: Anlotinib plus AK105

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing	China	100032

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT04803851

Other Study ID Numbers:

JS2791

First Posted:

Mar 18, 2021

Last Update Posted:

Mar 18, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Mar 18, 2021