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

Advanced Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803851
• Other study ID #: JS2791
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 12, 2021
• Est. completion date: June 29, 2024

Study information

• Verified date: February 2023
• Source: Peking Union Medical College Hospital
• Contact: XIANG WANG, Master
• Phone: 86-1069158773
• Email: wangxiang5123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: June 29, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Anlotinib
• Anti-PD-1 Antibody
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective response rate (ORR) based on RECIST V. 1.1	Objective response rate (ORR) based on RECIST V. 1.1 by investigators	6 weeks
Secondary	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	6 weeks
Secondary	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	6 weeks
Secondary	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).	6 weeks