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

Phase 1

Recruiting

• Conditions: Anlotinib; Anti-PD-1 Antibody; Advanced Pancreatic Cancer
• Interventions: Drug: Anlotinib plus AK105

• Registration Number: NCT04803851
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-05-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-06-18
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-02-28
• Study Completion: 2024-06-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Anlotinib plus AK105	Anlotinib plus AK105

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China