STRIDE + Lenvatinib for Liver Cancer
(SLIDE-HCC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new liver cancer treatment by adding the drug lenvatinib to a combination of durvalumab and tremelimumab to determine if it is more effective than the combination alone. The trial aims to discover if this three-drug mix can improve health outcomes for individuals with liver cancer that cannot be treated surgically. It seeks participants with liver cancer who have not received systemic therapy and are ineligible for surgery. This study may suit those whose liver cancer affects daily life and who cannot receive other local treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot take any other cancer treatments while participating. If you have hepatitis B or C, you must follow specific antiviral treatment guidelines during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that the combination of durvalumab and tremelimumab, known as STRIDE, holds promise in extending the lives of liver cancer patients. This suggests it is generally well-tolerated. Specifically, the five-year survival rate was 19.6% for patients using STRIDE, compared to 9.4% for those using sorafenib.
Another drug under investigation, lenvatinib, has also been used successfully to treat liver cancer. Past research indicated that patients taking lenvatinib lived for an average of 13.6 months, slightly longer than those taking sorafenib. These findings suggest lenvatinib is relatively safe in this context.
Overall, past research has shown that the treatments being studied have a good safety record, indicating they might be safe for participants in this trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about STRIDE with Lenvatinib for liver cancer because it combines two powerful immunotherapies, durvalumab and tremelimumab, with lenvatinib, a targeted therapy. While most treatments for liver cancer, like sorafenib or lenvatinib alone, focus on inhibiting cancer cell growth, STRIDE + Lenvatinib uniquely harnesses the immune system to attack cancer cells more effectively. This combination aims to enhance the body’s immune response and improve treatment outcomes by not only stopping tumor growth but also helping the immune system recognize and destroy cancer cells.
What evidence suggests that this trial's treatments could be effective for liver cancer?
Studies have shown that the combination of tremelimumab and durvalumab, known as STRIDE, can extend the lives of liver cancer patients. In one study, 19.6% of patients using STRIDE were alive after five years, compared to 9.4% of those using sorafenib, a common treatment. Tremelimumab and durvalumab together have demonstrated better survival rates than other treatments. In this trial, one group of participants will receive STRIDE alone, while another group will receive STRIDE combined with lenvatinib. Researchers aim to determine whether adding lenvatinib to STRIDE can further improve results. Early evidence suggests that combining these drugs might help control the disease and potentially shrink tumors.12467
Who Is on the Research Team?
Vincent Tam
Principal Investigator
Arthur J.E. Child Comprehensive Cancer Centre, Calgary AB, Canada
Jennifer Knox
Principal Investigator
University Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
Marilina Piccirillo
Principal Investigator
NCI-Naples, Italy
Are You a Good Fit for This Trial?
This trial is for adults with unresectable hepatocellular carcinoma (liver cancer) who haven't had systemic therapy before. They should have a liver function score of A or B7, at least one measurable tumor, and an expected survival of 12+ weeks. Participants must weigh over 30 kg and not be candidates for local treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either STRIDE (durvalumab + tremelimumab) or STRIDE with Lenvatinib for the treatment of unresectable hepatocellular carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
- Lenvatinib
- Tremelimumab
Trial Overview
The study tests the combination of STRIDE (durvalumab + tremelimumab) with Lenvatinib versus STRIDE alone in treating liver cancer. It aims to see if adding Lenvatinib improves outcomes compared to just using the two-drug combo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
AstraZeneca
Industry 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
National Cancer Institute, Naples
Collaborator
Citations
Tremelimumab plus Durvalumab in Unresectable ...
STRIDE significantly improved overall survival versus sorafenib. Durvalumab monotherapy was noninferior to sorafenib for patients with unresectable ...
STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs ...
The purpose of this study is to compare the effects on participants' and liver cancer by adding a drug that is used on its own to treat this disease to a ...
Durvalumab with tremelimumab for untreated advanced or ...
Evidence from a clinical trial suggests that durvalumab with tremelimumab increases how long people live compared with sorafenib. Indirect ...
Five-year overall survival update from the HIMALAYA study ...
The OS rate at 5 years was 19.6% with STRIDE vs. 9.4% with sorafenib. •. OS with STRIDE was improved with disease control and any degree of tumour shrinkage.
Four-year overall survival update from the phase III ...
One in four (25.2%) participants was alive at 4 years following treatment with STRIDE versus 15.1% with sorafenib, representing an unprecedented ...
Outcomes of Patients with Advanced Hepatocellular ...
The median overall survival was 13.6 months on lenvatinib compared to 12.3 months on sorafenib with superiority of secondary endpoints, ...
Outcomes in the Asian subgroup of the phase III ...
In an Asian subgroup of HIMALAYA, STRIDE improved overall survival and objective response rates vs. sorafenib. •. Outcomes were improved with ...
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