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Phase 2 Study of Durvalumab + Tremelimumab with Lenvatinib vs Durvalumab + Tremelimumab Alone in Patients with Unresectable Hepatocellular Carcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients with Hepatocellular Carcinoma that cannot be removed by surgery are being studied. The trial compares two treatment approaches: one uses an intravenous combination of durvalumab and tremelimumab (known as the STRIDE regimen) together with an oral pill containing lenvatinib, while the other uses the STRIDE regimen alone.

The purpose of the study is to see which approach keeps the cancer from getting worse for a longer time, measured as progression‑free survival. Participants receive a series of IV infusions of the two drugs every few weeks, and those in the combination arm also take the lenvatinib capsule each day. Treatment continues for several months, with regular check‑ups that include scans and safety assessments to monitor how the disease is responding and to watch for any side effects.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    After consent, the patient is assigned a study identification number and receives the study schedule.

  2. Step 2

    Baseline assessments

    The patient undergoes medical history review, physical examination, blood tests, and imaging studies to document the condition before treatment begins.

  3. Step 3

    First intravenous infusion

    The patient receives an intravenous infusion of durvalumab at a dose of 1500 mg and an intravenous infusion of tremelimumab at a dose of 300 mg on the same day.

    The infusion is administered by qualified staff in a clinical setting.

  4. Step 4

    Start of oral medication (combination arm)

    If assigned to the combination group, the patient begins taking lenvatinib 12 mg by mouth each day.

    The capsule is swallowed whole with water.

  5. Step 5

    Subsequent treatment cycles

    The patient returns for regular visits according to the study schedule.

    At each visit, the patient receives the same intravenous doses of durvalumab 1500 mg and tremelimumab 300 mg.

    The patient continues the daily oral dose of lenvatinib 12 mg for the duration of the combination treatment.

  6. Step 6

    Ongoing monitoring

    At each visit, blood tests and imaging are performed to assess disease status and safety.

    Any side effects are recorded and managed according to protocol.

  7. Step 7

    Treatment discontinuation

    The patient stops the study medication if disease progression is observed, if unacceptable toxicity occurs, or if the study ends.

  8. Step 8

    Final assessment

    After discontinuation, the patient undergoes a final set of examinations to document the outcome of the study participation.

Who can join the trial?

12 criteria

  • You must be 18 years old or older.
  • You must weigh more than 30 kg (about 66 lb).
  • You need a life expectancy of at least 12 weeks (about three months).
  • You must have a confirmed diagnosis of hepatocellular carcinoma (HCC), a type of liver cancer, either from a tissue sample or by using the criteria of the American Association for the Study of Liver Diseases (AASLD), and you must have imaging that shows at least one LI‑RADS 5 lesion (a spot on the scan that looks definitely cancerous).
  • You must not have received any previous systemic therapy (medicine that travels through the whole body) for HCC.
  • You must not be a candidate for locoregional therapy (treatments that target the tumor directly, such as ablation or embolization). If you had such treatment before, it must have been finished at least 28 days before the first scan for this study.
  • Your cancer must be classified as Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C (more advanced disease).
  • Your liver function must be scored as Child‑Pugh class A or B7 based on low albumin levels (albumin 2.5‑2.7 g/dL), which measures how well the liver is working.
  • Your overall health must be rated as ECOG performance status 0 or 1, meaning you are fully active or able to do light work.
  • You need at least one tumor that can be measured accurately on a CT or MRI scan: it must be at least 10 mm in its longest side (or a lymph node at least 15 mm in short side) and must not have been treated with radiation before. The measurement must follow RECIST 1.1 guidelines (standard rules for tracking tumor size).
  • If you have an active hepatitis B virus (HBV) infection (positive HBsAg or anti‑HBcAb with detectable HBV DNA), you must either be on antiviral medication that started before the study and continue during the study and for six months after, or have undetectable HBV DNA without needing medication. Your HBV levels will be checked regularly, and medication will be started if the virus becomes detectable.
  • Both men and women are eligible to participate.

Who cannot join the trial?

11 criteria

  • Having had any other type of cancer in the past, except for skin cancer that is not melanoma, cervical cancer that was treated while still in‑situ, or any other cancer that was cured and has had no signs of disease for at least five years.
  • Receiving chemotherapy (drugs that kill cancer cells), any study medication, biologic therapy (treatments made from living cells), or hormonal therapy for cancer at the same time. Hormone therapy for non‑cancer reasons, such as hormone replacement, is allowed.
  • Having specific forms of liver cancer called fibrolamellar HCC, sarcomatoid HCC, infiltrative‑type HCC, or a mixed tumor containing both cholangiocarcinoma and HCC.
  • Having significant fluid buildup in the abdomen (known as ascites) that required a procedure like paracentesis (draining fluid) within the last six months. If the fluid was only treated with medicines (diuretics) and the dose has been stable for at least two months, this is acceptable.
  • Having uncontrolled high blood pressure, defined as a systolic pressure of 150 mm Hg or higher, a diastolic pressure of 90 mm Hg or higher, or other serious blood‑pressure problems despite standard treatment.
  • Having previously been treated with a PD‑1 or PD‑L1 inhibitor (such as durvalumab) or an anti‑CTLA‑4 drug (such as tremelimumab).
  • Having a primary immune deficiency, a history of organ transplant, or having experienced a severe (grade 3 or 4) immune‑related side effect from another immune therapy.
  • Testing positive for HIV (human immunodeficiency virus) or having an active tuberculosis (TB) infection, as determined by medical evaluation or testing.
  • Having a known allergy or hypersensitivity (strong reaction) to any of the study drugs or any of their inactive ingredients.
  • Using immunosuppressive medication (drugs that lower the activity of the immune system) within 28 days before the first dose, except for nasal or inhaled steroids, or low‑dose oral steroids that do not exceed 10 mg per day of prednisone (or an equivalent).
  • Having an active autoimmune or inflammatory disorder such as inflammatory bowel disease (Crohn’s disease or ulcerative colitis), diverticulitis, systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis (Wegener’s), Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc., unless the condition meets specific exceptions (e.g., vitiligo, alopecia, stable hypothyroidism, diet‑controlled celiac disease, or other skin conditions that do not need systemic therapy).
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Investigated drugs

  • tremelimumab

    is a type of immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this study it is given through an IV (intravenous) infusion. The medication works by blocking a protein called CTLA‑4, which normally slows down the immune response, thereby allowing immune cells to stay active against the tumor.

  • durvalumab

    is another immunotherapy drug that is also administered by IV infusion. It helps the immune system by blocking a protein called PD‑L1, which cancer cells use to hide from immune attacks. By preventing this “hide‑and‑seek” mechanism, durvalumab encourages the body’s immune cells to find and destroy cancer cells.

  • lenvatinib

    is an oral medication taken as a capsule. It belongs to a class of drugs called tyrosine‑kinase inhibitors and works by blocking several signals that help cancer cells grow and form new blood vessels. By cutting off these signals, lenvatinib can slow the growth of the tumor.

  • STRIDE (durvalumab + tremelimumab)

    is the combination of the two immunotherapy drugs durvalumab and tremelimumab given together. In this trial the combination is used to boost the immune system’s ability to fight liver cancer. One group of patients receives STRIDE alone, while another group receives STRIDE together with the oral drug lenvatinib, allowing researchers to see if adding lenvatinib improves outcomes.

What is already known about the treatment

  • Tremelimumab

    Administered by intravenous infusion, tremelimumab is an experimental monoclonal antibody currently being studied in clinical trials. It is being tested mainly for cancers such as liver cancer that cannot be removed by surgery. The drug works by blocking the CTLA‑4 protein on immune cells, which helps the body’s T‑cells stay active and attack tumor cells. It belongs to the class of immune checkpoint inhibitors that target CTLA‑4.

  • Durvalumab

    Given as an intravenous infusion, durvalumab is an FDA‑approved monoclonal antibody used for certain bladder and lung cancers and is now being evaluated for liver cancer. It helps the immune system by binding to the PD‑L1 protein, preventing it from turning off T‑cells that can kill cancer cells. This action makes durvalumab a PD‑L1 inhibitor within the broader group of immune checkpoint inhibitors.

  • Lenvatinib

    Lenvatinib is taken orally in hard capsules, with each capsule containing the active drug. It is an approved treatment for several cancers, including advanced liver cancer, thyroid cancer, and kidney cancer. The medication blocks multiple tyrosine‑kinase receptors such as VEGFR, FGFR, and PDGFR, which reduces blood vessel growth that feeds tumors. It is classified as a multi‑kinase inhibitor, a type of targeted therapy.

Investigated diseases

Hepatocellular carcinoma - Hepatocellular carcinoma is a cancer that starts in the main cells of the liver. It can grow slowly at first and then become larger, affecting liver function. Over time the tumor may spread to nearby blood vessels and other parts of the body. When the tumor cannot be removed by surgery, it is called unresectable. The disease usually continues to enlarge and can involve other organs as it progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521608-23-00Protocol codeHE.2Estimated enrolment140 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

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