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Hepatocellular Carcinoma (HCC)Phase 2NCT07012798

FOLFOX Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma

A Phase 2 study testing Durvalumab, Bevacizumab and HAIC of FOLFOX in people with Hepatocellular Carcinoma (HCC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Study Design: This is a pilot study with a single arm in a single centre assessing safety and efficacy of durvalumab in combination with bevacizumab and HAIC followed by SBRT. This study will be conducted in selected patients with intermediate or advanced stage HCC not amenable to curative therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Durvalumab, Bevacizumab and HAIC of FOLFOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
25 Sep 2025to 31 Dec 2026
Phase
Phase 2
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

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Age > 18 years.
  • Confirmed HCC based on histopathological findings from tumor tissues.
  • HCC newly diagnosed or recurrent with a history of surgery or ablation, not amenable to curative surgery or transplantation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to screening.
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  • Tumours were classified as unresectable after a multidisciplinary team review because either:
  • R0 resection was not feasible
  • Sum of tumor diameters ≥5cm
  • A maximum of three tumour lesions
  • For patients with tumors located in bilateral hepatic lobes, the study requires that the number of tumors in the contralateral hepatic lobe of the larger tumor be less than 3, and the maximum tumor diameter should not exceed 3 cm.
  • Child-Pugh liver function score A.
  • Patients with PVTT (portal vein tumor thrombosis) classified as VP1 (tumor thrombus confined to distal second-order portal vein branches without involvement of the primary portal vein bifurcation) or VP2 (tumor thrombus involving second-order portal vein branches) were eligible for enrollment.
  • Patients with oligometastasis, defined as having a single metastatic organ with three or fewer metastases, each less than 3cm in size were permitted.
  • No prior radiotherapy or radioembolization to the liver or upper abdomen was allowed. Prior local therapies, such as surgery, radiofrequency ablation, percutaneous ethanol injection or cryoablation, are allowed if the index lesion(s) remain outside of the treatment field or have progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan.
  • Participants with HBV infection, characterized by positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU/ml or above the limit of detection per local lab standard), must be treated with antiviral therapy, as per institutional practice. Following antiviral therapy initiation, participants must show evidence of HBV stabilization or signs of viral response (eg, reduction HBV DNA levels) prior to study invention. Participants will remain on antiviral therapy for study duration and for 6 months after the last dose of study medication. Participants who test positive for anti HBV with undetectable HBV DNA (<10 IU/ml or under the limit of detection per local lab standard) do not require anti-viral therapy prior to enrollment. These subjects will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥10 IU/ml or above the limit of detection per local lab standard). HBV DNA detectable subjects must initiate and remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.
  • Patients with active HCV infection as characterized by the presence of detectable HCV RNA upon enrollment must be managed per local institutional practice.
  • Life expectancy of >12 weeks.
  • Body weight >30 kg.
  • Adequate organ and marrow function, as defined below. Criteria "a," "b," "c," and "f" cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose.
  • Hemoglobin ≥9 g/dL
  • Absolute neutrophil count ≥1000/µL
  • Platelet count ≥75000/µL
  • Total bilirubin (TBL) ≤2.0× upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • AST and ALT ≤5×ULN
  • Albumin ≥2.8 g/dL
  • International normalized ratio (INR) ≤ 1.6. Note: INR prolongation due to anticoagulants for prophylaxis (e.g. atrial fibrillation) in patients without liver cirrhosis could be an exception
  • Calculated creatinine clearance ≥40 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance
  • 2+ proteinuria or lower urine dipstick reading. Participants having > 2+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1 g/24 hours will be ineligible
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Female participants:
  • Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control (a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study.
  • Non-sterilized male partners of a woman of childbearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) throughout this period.
  • Must show evidence of post-menopausal status or have a negative urinary or serum pregnancy test for female pre-menopausal patients.
  • Male Participants:
  • Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening throughout the total duration of the study and for drugs that are potentially genotoxic the drug washout period to prevent pregnancy in a partner.
  • Male participants must not donate or bank sperm during this same time period.

Who cannot join

  • Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or infiltrative-type HCC.
  • Patients with PVTT classified as VP3 (involving first-order portal branches) or VP4 (involving the main portal trunk or contralateral/bilateral branches) were excluded from the study.
  • Prior radiotherapy to the liver or upper abdomen.
  • Participation in another clinical study with an investigational product.
  • 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.
  • Receipt of the systematic anticancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, monoclonal antibodies) prior to the first dose of study drug.
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  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of 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 investigator.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the investigator.
  • 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.
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogenic organ transplantation.
  • 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 investigator
  • Patients with celiac disease controlled by diet alone
  • 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.
  • History of another primary malignancy except for
  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP 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
  • History of leptomeningeal carcinomatosis
  • History of active primary immunodeficiency
  • Confirmed HBV infection must not be co-infected with HCV (as indicated by the absence of anti-HCV antibodies) or hepatitis D virus (HDV: as indicated by the absence of anti-HDV antibodies).
  • Confirmed HCV infection must not be co-infected with HBV as defined by negative HBsAg. Patients with confirmed HCV infection who are negative for HBsAg, but positive for anti-HBV with detectable HBV DNA, are eligible but must be started on active antiviral therapy (for HBV) prior to enrollment to ensure adequate viral suppression (HBV DNA ≤2000 IU/mL).
  • Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. 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 the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90days 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 90 days after the last dose of durvalumab monotherapy.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Prior treatment in a previous durvalumab clinical study regardless of treatment arm assignment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huikai Li contact

18622228633

tjchlhk@126.com

China1 site, 1 recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300308

    Li Huikai, MD, 18622228639, tjchlhk@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-arm, Single-center Phase II Clinical Study of Hepatic Artery Infusion Chemotherapy (FOLFOX) Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma

Study Design:

This is a pilot study with a single arm in a single centre assessing safety and efficacy of durvalumab in combination with bevacizumab and HAIC followed by SBRT. This study will be conducted in selected patients with intermediate or advanced stage HCC not amenable to curative therapy. Approximately 30 patients will be enrolled and receive treatments.

Read more

Primary Objectives:

To evaluate the possibility of HAIC plus durvalumab and bevacizumab followed by SBRT as conversion therapy for HCC.

Secondary Objective(s):

To evaluate the efficacy of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC.

To evaluate the safety of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC.

Exploratory Objective(s):

Evaluate the consistency of imaging CR and pathological CR in resected patients, and explore biomarkers associated with prognosis .

Being tested
Durvalumab, Bevacizumab, HAIC of FOLFOX
Keywords
Durvalumab, HAIC, SBRT, Conversion Therapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    1120mg, iv, q3w

  • BevacizumabDrug

    15mg/kg, iv, q3w

  • HAIC of FOLFOXDrug

    HAIC (FOLFOX): oxaliplatin 100mg/m2, 4h, day 1 + leucovorin 300mg/m2, 2h, day

    1 + fluorouracil 500mg/m2, 20min, day 1 + fluorouracil 1500mg/m2, 20h, q3w

Study groups in NCT07012798
Study groupRoleWhat they receive
TREATMENTExperimentaltherapy of durvalumab in combination with bevacizumab, combined with HAIC followed by SBRT
Receives: Drug: Durvalumab; Drug: Bevacizumab; Drug: HAIC of FOLFOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Conversion rate

    Measured: 3 MONTH

Secondary outcomes (7)

  1. Overall response rate (ORR) measured by RECIST v1.1, mRECIST.

    Measured: 6 MONTH

  2. Pathological complete response (pCR) for patients received resection.

    Measured: 6 MONTH

  3. Major pathologic response (MPR) for patients received resection.

    Measured: 6 MONTH

  4. AE

    Measured: 6 MONTH

  5. EFS

    1

    Measured: 1

  6. RFS

    Relapse free survival (RFS) for patients who received resection.

    Measured: 1year

  7. OS

    1-y, 2-y, 3-y Overall survival (OS) rate

    Measured: 3years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start25 Sep 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07012798
Sponsor's protocol ID
DB-HERO
Status last verified
Sep 2025
First submitted
27 May 2025
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, Bevacizumab and HAIC of FOLFOX in people with Hepatocellular Carcinoma (HCC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

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 37 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Huikai Li (18622228633, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conversion rate (time frame: 3 MONTH). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07012798.

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 May 2026.

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