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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anlotinib, Anti-PD-1 Antibody, Advanced Pancreatic Cancer

Intervention / Treatment
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* Drug: Anlotinib plus AK105


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Anlotinib plus AK105 | Drug: Anlotinib plus AK105<br>* Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) based on RECIST V. 1.1 | Objective response rate (ORR) based on RECIST V. 1.1 by investigators | 6 weeks | 
| 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 | 
| 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 | 
| 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 |