Resectable Hepatocellular CarcinomaPhase 1NCT05701488
SIRT With Tremelimumab and Durvalumab for Resectable HCC
A Phase 1 study testing Durvalumab, Tremelimumab and SIRT in people with Resectable Hepatocellular Carcinoma and Hepatocellular Carcinoma, run by Jiping Wang, MD, PhD at 3 sites in United States.
Trial summary
The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Hepatocellular Carcinoma, Hepatocellular Carcinoma, Hepatocellular Cancer
- What is being tested?
- Durvalumab, Tremelimumab and SIRT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2023to 1 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects (presence of arterial hypervascularity with venous washout). For subjects without cirrhosis, histological confirmation is mandatory.
- Participants must have resectable disease. Those patients must have preserved liver function (Child A) and with either AJCC stage IA, IB, II, and IIIA or BCLC stage 0 or stage A disease. The determination of resectability will ultimately lie in the clinical judgment of the treating investigator and surgical oncologist involved in the care of the patient.
- Participants must be treatment naïve for HCC.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of tremelimumab, durvalumab, and SIRT in participants <18 years of age, children are excluded from this study.
- Measurable disease per RECIST 1.1 criteria.
- ECOG performance status ≤ 1 (see Appendix A).
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- Body weight >30 kg.
- Participants must have adequate organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,000 /mcL
- Platelets ≥ 80,000 /mcL
- Total Bilirubin ≤ 2.0 mg/dL
- AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN)
- Measured Creatinine Clearance > 40 mL/min by 24-hour urine collection, or
- Calculated Creatinine Clearance (CL) > 40 mL/min by the Cockcroft-Gault Formula (Cockcroft Gault 1976):
- Males: Creatinine CL (mL/min) = (weight (kg) × (140 - Age)) / (72 × serum creatinine (mg/dL))
- Females: Creatinine CL (mL/min) = (weight (kg) × (140 - Age) / (72 × serum creatinine (mg/dL))) × 0.85
- Women of childbearing potential (WOCBP, refer to Section 5.4) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) obtained during the trial screening period.
- Men and WOCBP must agree to follow the protocol instructions for acceptable method(s) of contraception for the duration of trial treatment and for a total of 5 months post-treatment completion. Refer to Section 5.4.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as assessed by the treating investigator are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have received any prior treatment for HCC.
- Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to first dose of study drug.
- History of allogenic organ transplantation.
- Participants who are receiving any other investigational agents.
- 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
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- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients with celiac disease controlled by diet alone
- Patients without active disease in the last 5 years may be included but only after consultation with the sponsor-investigator
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab or tremelimumab.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection (including tuberculosis), uncontrolled hypertension (defined as blood pressure of > 140/90 mmHg during the screening period despite medical management), 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.
- Patients who have a primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of a stroke within the year prior to the first dose of study drug.
- History of active primary immunodeficiency.
- Known active infection of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- --Patients positive for HIV are allowed on study, but HIV-positive patients must have:
- A stable regimen of highly active anti-retroviral therapy (HAART)
- No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
- A CD4 count above 250 cells/mcL and an undetectable HIV viral load or standard PCR-based tests
- Known active hepatitis B infection (known positive HBV surface antigen (HBsAg) result). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
- Known active hepatitis C infection. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study agent. 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 that do not 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 the first dose of study drug. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study drug and for at least 30 days after the last dose of study agent.
- History of serious systemic disease, including myocardial infarction or unstable angina within the 12 months prior to the first dose of study drug, history of hypertensive crisis or hypertensive encephalopathy, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease.
- Participants who have a known clinical history of coagulopathy, bleeding diathesis, or thrombosis within the 12 months prior to the first dose of study drug.
- Participants who have a serious, non-healing wound, ulcer, bone fracture or with history of pneumonitis or interstitial lung disease.
- Participants who are pregnant or breastfeeding. A negative serum or urine pregnancy test obtained during the screening period is required for trial enrollment.
- Participants requiring total parenteral nutrition with lipids.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Phase 1 Neoadjuvant Trial of Selective Internal Yttrium-90 Radioembolization (SIRT) With Tremelimumab and Durvalumab (MEDI4736) for Resectable Hepatocellular Carcinoma
The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery.
The names of the interventions involved in this study are:
- Durvalumab (a type of immunotherapy)
- Tremelimumab (a type of immunotherapy)
- Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)
Read the detailed description
This is a Phase 1, open-label, randomized research study to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery.
Participants will be randomized into one of two treatment groups: Durvalumab + Tremelimumab versus Durvalumab + Tremelimumab + SIRT. Randomization means that a participant is put into a group by chance. Radioembolization is a combination of radiation therapy and a procedure called embolization to treat cancer. SIRT blocks tumor blood supply by injecting radioactive particles into the hepatic artery and delivers internal radiotherapy on the tumor.
The U.S. Food and Drug Administration (FDA) has not approved Durvalumab as treatment for HCC but it has been approved for other uses.
The U.S. FDA has not approved tremelimumab as a treatment option for HCC.
The research study procedures include screening for eligibility, study treatment including evaluations, radiology scans of the liver, blood tests, electrocardiograms, and follow up visits.
Participation in this study is expected to last about 18 months with long-term follow up for a maximum of 3 years.
It is expected that about 20 people will take part in this research study.
AstraZeneca, a pharmaceutical company, is supplying the study drugs, tremelimumab and durvalumab. Sirtex Medical Inc., a medical device company, is supplying the Yttrium-90 resin Microsphere beads.
- Being tested
- Durvalumab, Tremelimumab, SIRT
- Keywords
- Resectable Hepatocellular Carcinoma, Hepatocellular Carcinoma, Hepatocellular Cancer, Liver Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called Imjudo, MEDI4736
Intravenous infusion
TremelimumabDrug
Also called Imfinzi
Intravenous infusion
SIRTDevice
Also called Selective Internal Yttrium-90 Radioembolization
SIR (Selective Internal Radiation) Sphere resin microspheres, radioactive particles delivered via injection into an artery.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab + Tremelimumab (Arm A) | Experimental | -Participants will be randomized into the treatment group in a 1:1 ratio and will receive interventions as outlined:
Neoadjuvant Treatment:
* Cycle 1:
* Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab and Tremelimumab
* Day 28 of 28 Day cycle: Pre-determined dose of Durvalumab
* Participants will undergo surgery on day 49 of Cycle 1. Surgery will be performed per institutional standard of care.
Adjuvant Treatment:
--Cycles 1 (28 days postoperatively) - 13:
---Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab Receives: Drug: Durvalumab; Drug: Tremelimumab |
| Durvalumab + Tremelimumab + SIRT (Arm B) | Experimental | -Participants will be randomized into the treatment group in a 1:1 ratio and will receive interventions as outlined:
Neoadjuvant Treatment:
* Cycle 1:
* Day 3 of 28 Day Cycle: Pre-determined dose of Durvalumab and Tremelimumab
* Day 31 of 28 Day Cycle: Pre-determined dose of Durvalumab
* Day 1 of 28 Day Cycle: Yttrium-90
* Participants will undergo surgery on Day 52 of Cycle 1. Surgery will be performed per institutional standard of care.
Adjuvant Treatment:
--Cycles 1 (28 days postoperatively) - 13:
---Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab Receives: Drug: Durvalumab; Drug: Tremelimumab; Device: SIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Defined as All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 AE of any type during the time of observation.
Measured: up to 18 months
Secondary outcomes (8)
Best Radiologic Response
Defined as best radiologic response on treatment and evaluated per RECIST 1.1 criteria.
Measured: up to 15 months
Best Pathological Response
Defined as the best pathological response based on evaluation of the surgical sample defined per protocol for gross and microscopic evaluation.
Measured: up to 65 days
Median Overall Survival (OS)
Calculated via the Kaplan-Meier method and defined as the time from study entry to death or censored at date last known alive.
Measured: up to 3 years
Median Progression-Free Survival (PFS)
Calculated via the Kaplan-Meier method and defined as the duration between randomization and documented disease progression or death, or is censored at time of last disease assessment.
Measured: up to 3 years
CD8+/CD4+T Cells Level
Comparison between pre-treatment and post-treatment via paired t-test and Wilcoxon signed rank test and Fisher's exact test.
Measured: up to 3 years
Dendritic Cells Level
Comparison between pre-treatment and post-treatment via paired t-test and Wilcoxon signed rank test and Fisher's exact test.
Measured: up to 3 years
Cytokines Level
Comparison between pre-treatment and post-treatment via paired t-test and Wilcoxon signed rank test and Fisher's exact test. IL-1b, IL-2, IL-6, TNFa, IFNg, CCL2, IL-8, IL-18, CXCL9, CXCL10 will be measured by cytokine bead array and reported as picrograms per mL (pg/mL).
Measured: up to 3 years
Number of Participants with Surgical Complications
Surgical complications will be defined by postoperative occurrences and defined according National Surgical Quality Improvement Program (NSQIP) criteria.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start21 Apr 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiping Wang, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Sirtex Medical
- Responsible party
- Sponsor-investigator, Jiping Wang, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Jiping Wang, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701488
- Sponsor's protocol ID
- 22-401
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Neoadjuvant Trial of Selective Internal Yttrium-90 Radioembolization (SIRT) With Tremelimumab and Durvalumab (MEDI4736) for Resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05701488
- Acronym / sponsor ID
- 22-401
- Keywords
- Resectable Hepatocellular Carcinoma, Hepatocellular Carcinoma, Hepatocellular Cancer, Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiping Wang, MD, PhDUniversity, hospital or other
- Collaborators
- AstraZeneca, Sirtex Medical
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery.
The names of the interventions involved in this study are:
- Durvalumab (a type of immunotherapy)
- Tremelimumab (a type of immunotherapy)
- Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)
Detailed description
This is a Phase 1, open-label, randomized research study to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery.
Participants will be randomized into one of two treatment groups: Durvalumab + Tremelimumab versus Durvalumab + Tremelimumab + SIRT. Randomization means that a participant is put into a group by chance. Radioembolization is a combination of radiation therapy and a procedure called embolization to treat cancer. SIRT blocks tumor blood supply by injecting radioactive particles into the hepatic artery and delivers internal radiotherapy on the tumor.
The U.S. Food and Drug Administration (FDA) has not approved Durvalumab as treatment for HCC but it has been approved for other uses.
The U.S. FDA has not approved tremelimumab as a treatment option for HCC.
The research study procedures include screening for eligibility, study treatment including evaluations, radiology scans of the liver, blood tests, electrocardiograms, and follow up visits.
Participation in this study is expected to last about 18 months with long-term follow up for a maximum of 3 years.
It is expected that about 20 people will take part in this research study.
AstraZeneca, a pharmaceutical company, is supplying the study drugs, tremelimumab and durvalumab. Sirtex Medical Inc., a medical device company, is supplying the Yttrium-90 resin Microsphere beads.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durvalumab + Tremelimumab (Arm A) | Experimental | Drug: Durvalumab, Drug: Tremelimumab-Participants will be randomized into the treatment group in a 1:1 ratio and will receive interventions as outlined: Neoadjuvant Treatment: * Cycle 1: * Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab and Tremelimumab * Day 28 of 28 Day cycle: Pre-determined dose of Durvalumab * Participants will undergo surgery on day 49 of Cycle 1. Surgery will be performed per institutional standard of care. Adjuvant Treatment: --Cycles 1 (28 days postoperatively) - 13: ---Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab |
| Durvalumab + Tremelimumab + SIRT (Arm B) | Experimental | Drug: Durvalumab, Drug: Tremelimumab, Device: SIRT-Participants will be randomized into the treatment group in a 1:1 ratio and will receive interventions as outlined: Neoadjuvant Treatment: * Cycle 1: * Day 3 of 28 Day Cycle: Pre-determined dose of Durvalumab and Tremelimumab * Day 31 of 28 Day Cycle: Pre-determined dose of Durvalumab * Day 1 of 28 Day Cycle: Yttrium-90 * Participants will undergo surgery on Day 52 of Cycle 1. Surgery will be performed per institutional standard of care. Adjuvant Treatment: --Cycles 1 (28 days postoperatively) - 13: ---Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects (presence of arterial hypervascularity with venous washout). For subjects without cirrhosis, histological confirmation is mandatory.
- Participants must have resectable disease. Those patients must have preserved liver function (Child A) and with either AJCC stage IA, IB, II, and IIIA or BCLC stage 0 or stage A disease. The determination of resectability will ultimately lie in the clinical judgment of the treating investigator and surgical oncologist involved in the care of the patient.
- Participants must be treatment naïve for HCC.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of tremelimumab, durvalumab, and SIRT in participants <18 years of age, children are excluded from this study.
- Measurable disease per RECIST 1.1 criteria.
Key exclusion criteria (31 listed)
- Participants who have received any prior treatment for HCC.
- Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to first dose of study drug.
- History of allogenic organ transplantation.
- Participants who are receiving any other investigational agents.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: Imjudo, MEDI4736Intravenous infusion | Drug | Durvalumab + Tremelimumab (Arm A), Durvalumab + Tremelimumab + SIRT (Arm B) |
| TremelimumabAlso: ImfinziIntravenous infusion | Drug | Durvalumab + Tremelimumab (Arm A), Durvalumab + Tremelimumab + SIRT (Arm B) |
| SIRTAlso: Selective Internal Yttrium-90 RadioembolizationSIR (Selective Internal Radiation) Sphere resin microspheres, radioactive particles delivered via injection into an artery. | Device | Durvalumab + Tremelimumab + SIRT (Arm B) |
Primary outcome
Number of Participants with Adverse Events
Time frame: up to 18 months
Defined as All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 AE of any type during the time of observation.
8 secondary outcomes
Best Radiologic Response
Time frame: up to 15 months
Best Pathological Response
Time frame: up to 65 days
Median Overall Survival (OS)
Time frame: up to 3 years
Median Progression-Free Survival (PFS)
Time frame: up to 3 years
CD8+/CD4+T Cells Level
Time frame: up to 3 years
Dendritic Cells Level
Time frame: up to 3 years
Cytokines Level
Time frame: up to 3 years
Number of Participants with Surgical Complications
Time frame: up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiping Wang, MD, PhD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Durvalumab, Tremelimumab and SIRT in people with Resectable Hepatocellular Carcinoma and Hepatocellular Carcinoma, run by Jiping Wang, MD, PhD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.