STRIDE Regimen + LRT for Liver Cancer

Overseen By Manaf Alsudaney, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ju Dong Yang

Must not be taking: Immunotherapy, Immunosuppressants

Disqualifiers: Autoimmune diseases, Active tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 12

Duration: Up to 48 weeks

41 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating liver cancer, known as hepatocellular carcinoma (HCC). It combines two immunotherapy drugs, Durvalumab and Tremelimumab, with a liver-targeted procedure to determine if they can safely shrink or control the cancer. The ultimate goal is to lower the cancer stage, allowing more patients to qualify for a liver transplant. People with inoperable liver cancer, confirmed by a doctor, may be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in liver cancer treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of Durvalumab and Tremelimumab is generally well-tolerated by people with liver cancer. Studies have found that managing the side effects of this treatment is possible. In one study, only a small number of patients experienced severe side effects, while most side effects were mild to moderate, such as fatigue or nausea. Importantly, real-world results confirm the safety of this combination, with similar outcomes across different trials. These findings suggest that the treatment is safe enough for further testing, but discussing potential risks with a healthcare provider before joining a trial remains crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the STRIDE regimen for liver cancer because it combines two immunotherapy drugs, Durvalumab and Tremelimumab, which work together to enhance the immune system's ability to fight cancer. Unlike traditional treatments such as surgery or chemotherapy, this combination specifically targets the immune checkpoints that cancer cells use to avoid detection. The innovative aspect of STRIDE is its use alongside local regional therapies like TACE, TARE, or RFA, aiming to boost localized treatment effects while engaging the body's immune response. This dual approach could potentially improve outcomes for patients with advanced liver cancer, offering a new hope beyond the standard options.

What evidence suggests that this trial's treatments could be effective for liver cancer?

Research has shown that using durvalumab and tremelimumab together may help treat liver cancer, specifically hepatocellular carcinoma (HCC). In this trial, participants will receive the STRIDE Regimen, which combines Tremelimumab 300 mg and Durvalumab 1500 mg, along with a liver-directed tumor procedure (LRT) such as TACE, TARE, or RFA. The HIMALAYA study found that this combination can help patients with advanced HCC live longer, offering better survival rates compared to other treatments. This combination also shrinks tumors and slows cancer growth. Early results indicate that the treatment is generally safe, providing a hopeful option for people with advanced liver cancer. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Negative pregnancy test for subjects of childbearing potential and agreement to use contraception

I have been diagnosed with liver cancer and expect to live at least 12 more months.

Written informed consent obtained from subject and ability to comply with study requirements

Exclusion Criteria

My liver cancer is a rare or mixed type, not the common form.

Active or history of autoimmune diseases

Lack of interest or inadequate psychosocial support for organ transplantation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of immunotherapy (STRIDE regimen) and liver-directed tumor treatment (LRT) such as Yttrium-90, TACE, or RFA

Up to 48 weeks

12 visits (in-person, approximately every 4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biomarker assessments

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Durvalumab
• Liver-directed Tumor Procedure
• Tremelimumab

How Is the Trial Designed?

Group I: Age ≥ 18 Patients with HCC beyond UCSF criteria, ECOG performance status ≤ 2, and Child-Pugh A or B7 Experimental Treatment 1 Intervention

STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA)

Who Is Running the Clinical Trial?

Ju Dong Yang

Lead Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12401040/

Efficacy of Durvalumab‐Tremelimumab Treatment in ... - PMC

Systemic therapy with immune checkpoint inhibitors for advanced hepatocellular carcinoma (HCC) treatment has demonstrated high response rates.

2.

evidence.nejm.org

evidence.nejm.org/doi/full/10.1056/EVIDoa2100070

Tremelimumab plus Durvalumab in Unresectable ...

The primary outcome was overall survival, defined as time from date of randomization until death from any cause, for STRIDE versus sorafenib.

3.

ajmc.com

ajmc.com/view/real-world-results-of-durvalumab-tremelimumab-in-u-hcc-show-promise-despite-line-of-therapy

Real-World Results of Durvalumab/Tremelimumab in U- ...

The phase 3 trial found median overall survival (OS) was 16.4 months on the combination compared with 16.6 months on durvalumab monotherapy, and ...

4.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(24)00049-8/fulltext

Four-year overall survival update from the phase III ...

The survival rates at 18, 24, 36, and 48 months were 47.4%, 39.6%, 24.7%, and 19.3%, respectively, in the durvalumab arm. OS in the prespecified ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41992826/

Real-World Data From the LOR-HCC (Lombardy ...

In routine clinical practice, STRIDE shows reproducible effectiveness and a manageable safety profile, with an early and stabilising incidence of adverse ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12830029/

Early Safety Results from the Phase 3b SIERRA Study ... - PMC

Early Safety Results from the Phase 3b SIERRA Study of Durvalumab and Tremelimumab as First-Line Treatment for Participants with Unresectable ...

7.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2026.44.2_suppl.541

Safety outcomes with tremelimumab (T) rechallenge in the ...

Outcomes are assessed at 3 yrs (primary DCO: Aug 27, 2021) and 5 yrs (DCO: Mar 1, 2024) of follow-up. Results: At the 3-yr DCO, 30/393 (8%) pts ...

8.

jhep-reports.eu

jhep-reports.eu/article/S2589-5559(25)00368-4/fulltext

Results of the DT-real study

Reproducible safety and efficacy of durvalumab with or without tremelimumab for hepatocellular carcinoma in clinical practice: Results of the DT-real study.

9.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(25)03044-3/abstract

1494P Pooled efficacy and safety outcomes with ...

In the phase 3 HIMALAYA study (NCT03298451) in uHCC, STRIDE (Single Tremelimumab Regular Interval Durvalumab) significantly improved overall survival (OS) vs ...