Durvalumab-Based Therapies for Liver Cancer
(LIVER-R Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how well the drug durvalumab works for individuals with certain liver and bile duct cancers. Researchers seek to observe patient outcomes in real-life settings, focusing on survival after treatment. The trial will examine different groups: those with liver cancer that cannot be surgically removed and those with advanced bile duct cancer. Eligible participants have been diagnosed with these cancers and are receiving durvalumab, an immunotherapy drug, as part of their regular treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for durvalumab-based treatments?
Research has shown that durvalumab is usually well-tolerated for treating liver cancer that cannot be surgically removed. Compared to the usual treatment, sorafenib, durvalumab has a similar safety profile. However, some patients may experience liver-related side effects, especially when combined with tremelimumab.
For advanced biliary tract cancer, durvalumab is often used with chemotherapy drugs. Studies have found that this combination can significantly improve survival rates. Most patients in these studies experienced side effects, but they were generally manageable. Common side effects include tiredness, nausea, and changes in liver function.
Both treatments have undergone extensive study, and while side effects can occur, they are often mild to moderate. It is important to discuss the possible risks and benefits with a doctor before joining a trial.12345Why are researchers excited about this trial?
Researchers are excited about the LIVER-R observational study because it aims to gather valuable insights into the management of unresectable hepatocellular carcinoma (uHCC) and advanced biliary tract cancer (aBTC). Unlike traditional treatment trials that test new drugs, this study focuses on understanding how existing treatment strategies impact patient outcomes. By observing real-world cases, researchers hope to identify potential gaps in current care, improve treatment protocols, and ultimately enhance patient survival and quality of life. This approach could lead to more effective, personalized treatment plans for those battling these challenging liver and biliary tract cancers.
What evidence suggests that durvalumab-based regimens could be effective for hepatobiliary cancer?
Research shows that durvalumab holds promise for treating certain liver and bile duct cancers. In this trial, participants with liver cancer that cannot be removed by surgery (uHCC) will receive durvalumab. Studies have found that durvalumab, especially when combined with another drug called tremelimumab, extends patient survival compared to the usual treatment, sorafenib. Specifically, the HIMALAYA study demonstrated that this combination improved survival rates, offering hope to patients. Meanwhile, participants with advanced bile duct cancer (aBTC) in this trial will also receive durvalumab. The TOPAZ-1 trial found that durvalumab, when combined with the chemotherapy drugs gemcitabine and cisplatin, significantly improved survival compared to chemotherapy alone. Real-world studies also support these findings, showing consistent effectiveness. This evidence suggests that treatments based on durvalumab could be effective and beneficial for these cancers.24678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Collection of patient demographic and clinical characteristics up to 5 years prior to the index date
Treatment
Patients receive durvalumab-based regimens as part of routine clinical practice or early access program
Follow-up
Participants are monitored for real-world overall survival, progression-free survival, and other clinical endpoints
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
unresectable hepatocellular carcinoma (uHCC)
advanced biliary tract cancer (aBTC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
ICON plc
Industry Sponsor
Dr. Steve Cutler
ICON plc
Chief Executive Officer since 2017
PhD from the University of Sydney, MBA from the University of Birmingham
Dr. Greg Licholai
ICON plc
Chief Medical Officer since 2023
Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College
Citations
Durvalumab (DUR) effectiveness in advanced biliary tract ...
Based on TOPAZ-1 trial, Durvalumab (DUR) plus gemcitabine and cisplatin significantly improved overall survival (OS) in advanced biliary tract cancer (aBTC) ...
Real-world effectiveness and prognostic factors of ...
This real-world study demonstrated the comparable efficacy of durvalumab plus chemotherapy to the TOPAZ-1 trial for patients with advanced BTC and identified ...
3-year overall survival update from the phase III TOPAZ-1 ...
At the TOPAZ-1 (NCT03875235) primary analysis, durvalumab plus gemcitabine and cisplatin (GemCis) significantly improved overall survival (OS) in advanced ...
Real-world effectiveness and prognostic factors of durvalumab ...
Outcomes ... , et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: an early exploratory analysis of real-world data.
The real-world clinical effectiveness of durvalumab in ...
Conclusions: The efficacy and safety of the DGC regimen for patients with advanced BTC are confirmed through a comparative analysis and ...
Durvalumab in Advanced Biliary Tract Cancer: Real-World ...
Median PFS was 7.6 months (95% CI: 7.2-8.1), and median OS was 15.6 months (95% CI: 14.8-16.5). ORR was 35.6%, and DCR was 82.7%. Any grade AEs occurred in 1213 ...
Durvalumab plus Gemcitabine and Cisplatin in Advanced ...
Durvalumab plus chemotherapy significantly improved overall survival versus placebo plus chemotherapy and showed improvements versus placebo ...
133O Safety of 30 min infusion of durvalumab (D) in ...
The global, single-arm, Phase 3b TOURMALINE study (NCT05771480) assesses the safety and efficacy of D + G-based chemotherapy as first-line tx in aBTC.
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