Axitinib for Liver Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Liver CancerAxitinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial shows that for some types of cancer, a new immunotherapy drug can help to fight the disease even after the tumor has grown.

Eligible Conditions
  • Liver Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 48 months.

Month 24
Combined Modality Therapy
Month 48
6-month progression-free survival
Disease Control Rate
Duration of response
Overall Survival
Safety profile as measured by the number of participants with AEs (serious / non-serious) as graded by NCI CTCAE v5.0
Safety profile as measured by the number of participants with lab abnormalities as graded by NCI CTCAE v5.0

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Axitinib
30%Mucositis
10%nausea
10%Fatigue
10%Rash
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02129647) in the Axitinib ARM group. Side effects include: Mucositis with 30%, nausea with 10%, Fatigue with 10%, Rash with 10%.

Trial Design

1 Treatment Group

Axitinib / Avelumab /Bavituximab
1 of 1

Experimental Treatment

29 Total Participants · 1 Treatment Group

Primary Treatment: Axitinib · No Placebo Group · Phase 2

Axitinib / Avelumab /BavituximabExperimental Group · 3 Interventions: Avelumab, Axitinib, Bavituximab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2017
Completed Phase 3
~3040
Axitinib
2013
Completed Phase 2
~4590
Bavituximab
2011
Completed Phase 2
~190

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 48 months.

Who is running the clinical trial?

PfizerIndustry Sponsor
4,304 Previous Clinical Trials
7,094,750 Total Patients Enrolled
3 Trials studying Liver Cancer
340 Patients Enrolled for Liver Cancer
University of Texas Southwestern Medical CenterLead Sponsor
951 Previous Clinical Trials
607,795 Total Patients Enrolled
2 Trials studying Liver Cancer
48 Patients Enrolled for Liver Cancer
David Hsieh, MDPrincipal InvestigatorAssistant Professor
1 Previous Clinical Trials
28 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies.
Measurable disease, as defined as lesions that can accurately be measured in at least one dimension according to RECIST version 1.1 at least 1 cm with contrast enhanced dynamic imaging (magnetic resonance imaging or computed tomography).