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Checkpoint Inhibitor

Stride (Single T Regular Interval D) Arm for Liver Cirrhosis

Phase 2
Waitlist Available
Led By Sukeshi Arora, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Patients diagnosed with HCC based on pathologic diagnosis from biopsy or radiographic diagnosis on CT liver or MRI liver (i.e., Barcelona Clinic Liver Cancer (BCLC) stage B and not candidate for locoregional therapies or BCLC stage C)10
2. Patients with Child-Pugh-B7 or -B8 liver cirrhosis11
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 year
Awards & highlights

Summary

This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial/ethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge.

Who is the study for?
This trial is for adults with advanced liver cancer or hepatocellular carcinoma who are fit for first-line treatment. It's especially aimed at those often underrepresented in trials, like racial/ethnic minorities and individuals from low socioeconomic backgrounds. Participants must have a specific level of liver impairment known as Child-Pugh-B cirrhosis.
What is being tested?
The study tests the combination of two drugs, Tremelimumab and Durvalumab (T300+D), on patients with advanced liver cancer to see if it's safe and can be tolerated. This phase II trial does not compare against other treatments but aims to gather safety data specifically in a diverse patient population.
What are the potential side effects?
Potential side effects of Tremelimumab and Durvalumab may include immune-related reactions such as inflammation in various organs, skin rash, hormone gland problems, fatigue, nausea, and possibly an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade 3 or Higher Treatment Related Treatment Emergent-Adverse Events (TRTE-AEs)
Secondary study objectives
Albumin-Bilirubin (ALBI) grade
Objective Response Rate (ORR)
Overall Survival (OS)
+1 more
Other study objectives
EORTC QLQ-HCC18 (18-item hepatocellular cancer health-related quality of life questionnaire)
European Organisation For Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stride (Single T Regular Interval D) ArmExperimental Treatment2 Interventions
Tremelimumab dosed once at the beginning of the first cycle, 300mg IV infusion and Durvalumab 1500mg IV dosed with the first dose of Tremelimumab and then once per cycle (every 4 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3130
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
463 Previous Clinical Trials
91,967 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,331 Previous Clinical Trials
288,640,053 Total Patients Enrolled
2 Trials studying Liver Cirrhosis
261 Patients Enrolled for Liver Cirrhosis
Sukeshi Arora, MDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
~21 spots leftby Oct 2027
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