Can two immunotherapy drugs make liver tumors more vulnerable to surgery?
NCT ID NCT07027436
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether adding two immunotherapy drugs, durvalumab and tremelimumab, to focused radiation before surgery changes the immune cell makeup inside liver tumors. The trial enrolls 30 people with a single liver tumor that can be removed surgically. Everyone receives radiation, and half also receive the immunotherapy drugs. By comparing tumor tissue before and after treatment, the team looks for shifts in immune cells that might make the cancer more responsive to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab and tremelimumab, two immunotherapy drugs, added to stereotactic body radiation therapy before surgery
- What this could lead to
- If the combination changes the tumor's immune environment in the hoped-for way, it could point toward better pre-surgery treatment for liver cancer and help researchers design larger trials.
- What could go wrong
- This is a small early-phase window trial with only 30 participants, so any immune changes seen may not translate into better outcomes or apply to all liver cancer patients. Immunotherapy can also cause serious immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Radiologically or biopsy proven solitary HCC without biliary invasion or metastases, Liver Imaging Reporting and Data Systems (LI- RADS) 4 or 5 only. Participants with satellite tumour nodules are eligible. Satellitosis or a satellite nodule is defined as a tumour (LI-RADS 4 or 5 only) less than or equal to 2 cm and located less than or equal to 2 cm from the main tumour. Tumour less than 12 cm in maximum size on CT or MRI. Planned surgical resection of HCC with a life expectancy of at least 12 weeks Age \>18 years at time of study entry. Child-Pugh Class A within 14 days prior to study enrollment Eastern Cooperative Oncology Group (ECOG) of 0 or 1 (see Appendix 3) Body weight \>30 kg at time of study enrollment Adequate normal organ and marrow function as defined below: Haemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC ≥1.0 × 109 /L) Platelet count ≥75 × 109/L Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine clearance CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Males: Creatinine CL (mL/min) = Weight (kg) x (140 - Age)72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL) Patient is capable and willing to provide signed informed consent. Exclusion Criteria: * Previous therapy for HCC, including systemic therapy, surgery, radiation therapy, ablation or embolization. Participation in another clinical study with an investigational product during the last 4 weeks or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. Previous radiation therapy or surgery within 4 weeks of the randomization. Previous allogenic organ transplantation Previous anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy Previous receipt of durvalumab and / or tremelimumab or allergy to it Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy except for alopecia, vitiligo, and the laboratory values defined in the inclusion criteria Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion: Patients with vitiligo or alopecia Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the study physician Patients with celiac disease controlled by diet alone History of active primary immunodeficiency Conditions that would preclude administration of durvalumab and / or tremelimumab Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Patients with a past or resolved HBV infection (defined as the presence of antiHBc and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. b.1. Patients co-infected with HBV and HCV or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and/or anti HBcAb with detectable HBV DNA); and b.2. HCV positive (presence of anti-HCV antibodies); or b.3. HDV positive (presence of anti-HDV antibodies) b.4. Patients with HBV infection, characterized by positive HBsAg and/or anti-HBcAb with undetectable HBV DNA (\< 10 IU/ml or under the limit of detection per local lab standard) do not require antiviral therapy prior to enrollment. These patients will be tested once for HBV DNA levels; if HBV DNA is detected (≥ 10 IU/ml or above the limit of detection per local lab standard), antiviral therapy must be initiated, continued for the study duration and for 6 months after the last dose of IP. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) which is not well controlled or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice). c.1. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load for 3 months, CD4+ count of \>200 no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 3 months on the same anti-HIV medications. History of another primary malignancy, except for Malignancy treated with curative intent and with no known active disease ≥2 years before randomization and of low potential risk for recurrence Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease Current or prior use of immunosuppressive medication within 14 days before enrollment. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) Receipt of live attenuated vaccine within 30 days prior to enrollment. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab and tremelimumab combination therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Juravinski Hospital
RECRUITINGHamilton, Ontario, L8V 1C3, Canada
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London Health Sciences Centre
ACTIVE_NOT_RECRUITINGLondon, Ontario, N6A 5W9, Canada
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