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Hepatocellular CarcinomaNCT04517227

The Combination Therapy of TACE and Ablation With Durvalumab in Hepatocellular Carcinoma at Intermediate Stage (TAD)

A study testing Durvalumab, Transcatheter Hepatic Arterial Chemoembolization (TACE) and Ablation in people with Hepatocellular Carcinoma, run by Fudan University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a pilot study with a single arm in a single center assessing safety and efficacy of combination therapy of TACE and ablation and durvalumab. This study will be conducted in selected patients with intermediate 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
What is being tested?
Durvalumab, Transcatheter Hepatic Arterial Chemoembolization (TACE) and Ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Jul 2021to Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

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 (eg, Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Age > 18 years.
  • Have a HCC diagnosis confirmed by radiology, histology, or cytology. Note: Radiologic confirmation diagnosis is provided by the study site. Definition of radiological confirmation: Clinical findings consistent with the diagnosis of a liver mass measuring at least 1 cm with characteristic vascularization (intense enhancement seen in the hepatic arterial-dominant phase and contrast washout in the late portal venous phase) seen in either triphasic computed tomography (CT) scan or magnetic resonance imaging (MRI).
  • HCC newly diagnosed or recurrent with a history of surgery or ablation, with Barcelona Clinic Liver Cancer (BCLC) Stage B not amenable to curative surgery or transplantation or that the patient refuses surgery.
  • At least 1 measurable intrahepatic lesion (≥1.0 cm) according to RECISTv1.1 criteria, which is suitable for repeat assessments.
  • Tumor size and number requirement: 1 nodule (5cm ≤ size ≤ 7cm); 2-3 nodules, at least 1 nodule > 3cm, and any nodule ≤ 7cm; 4-5 nodules, any nodule size ≤ 7cm;
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  • Tumors amenable for initial TACE treatment (Permitted modalities are DEB-TACE or cTACE).
  • Tumors were assessed with planning ultrasound and suitable for ablation (by experienced doctor to assess and perform ablation procedure).
  • Child-Pugh score class A to B7.
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  • Adequate normal organ and marrow function as defined below, Criteria 'a','b','c' and 'f' allow no transfusions, infusions, or growth factor support administered within 14 days before laboratory test: a. Haemoglobin ≤9.0 g/dL; b. Absolute neutrophil count (ANC) ≥1.0 × 10^9 /L; c. Platelet count ≥50 × 10^9/L; d. Serum total bilirubin ≤2 × institutional upper limit of normal (ULN); e. AST (SGOT)/ALT (SGPT) ≤5× ULN; f. Albumin ≥28 g/L; g. International normalized ratio ≤1.6 and prothrombin time ≤16 s; h. Measured creatinine clearance (CL) >50 mL/min or Calculated creatinine CL>50 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), Females: Creatinine CL (mL/min)=Weight (kg) x (140-Age) ×0.85 / (72 x serum creatinine).
  • 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.

Who cannot join

  • History or concurrent use of anticancer therapy (local regional therapy and systemic therapy), including investigational products. 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. Patients with the recurrence from a radical surgery or ablation are allowed. Evidence for radical surgery or ablation should be provided with enhanced MRI/CT after at least 4 weeks after the treatment and AFP level should also be negative in at least 4 weeks after the radical treatment; Chinese traditional medicine with CFDA approval for anticancer use should be washout for 14 days before enrolment.
  • Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or infiltrative-type HCC
  • History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
  • Ascites requiring invasive intervention (eg, paracentesis) to maintain symptomatic control, within 4 weeks prior to enrolment
  • Visible portal vein tumor thrombosis detected on baseline/eligibility imaging
  • New York Heart Association Grade ≥2 congestive heart failure; or QTcF value ≥470 ms detected by 12-lead electrocardiogram.
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  • History of stroke or myocardial infarction or cerebral hemorrhage within 6 months prior to enrolment
  • Significant traumatic injury or major surgical procedure (as defined by the Investigator) within 4 weeks prior to enrolment.
  • Active GI bleeding, with history of GI bleeding within 6 months, or investigator defined with high risk of haemorrhage for esophageal varices.
  • Current use of systemic anticoagulation or anti-platelet drugs.
  • History of allogenic organ transplantation.
  • Patients weighing ≤30 kg
  • Active or prior documented autoimmune or inflammatory disorders. 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; Patients with celiac disease controlled by diet alone
  • History of active primary immunodeficiency
  • History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease ≥5 years before the first day of study treatment and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer without evidence of disease; Adequately treated carcinoma in situ without evidence of disease
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).
  • Uncontrolled Hepatitis B (HBV DNA >2000 IU/mL); Patients co-infected with HBV and HCV (characterized by detectable HCV RNA, together with positive HBsAg or detectable HBV DNA according to local laboratory standards). Anti-viral therapy is recommended following the local guidelines. Patients with a non-viral etiology are allowed.
  • Current or prior use of immunosuppressive medication within 14 days before enrolment. The following are exceptions to this criterion:a. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection);b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent;c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication, TACE procedure)
  • Uncontrolled intercurrent illness, including but not limited to, unstable angina pectoris, 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 leptomeningeal carcinomatosis.
  • 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.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Receipt of live attenuated vaccine within 30 days prior to the enrolment. Note: Patients, if enrolled, should not receive live vaccine until 30 days after the last dose of durvalumab.
  • 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.
  • Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)

About this study

Official title: A Single-Arm Open-Label Pilot Study of Combination Therapy of TACE and Ablation With Durvalumab in A Selected Hepatocellular Carcinoma Population at Intermediate Stage

This is a pilot study with a single arm in a single center assessing safety and efficacy of combination therapy of TACE and ablation and durvalumab. This study will be conducted in selected patients with intermediate stage HCC not amenable to curative therapy.

Read the detailed description

Approximately 30 patients will be enrolled and receive the following treatments:

TACE (day 1, up to twice. TACE interval will be 4～6 weeks) → Ablation (4 weeks after the last TACE, up to twice. Ablation interval will be 4～6 weeks) → Durvalumab (at least 1 week after the last ablation, 1500 mg Q4W, until mRECIST criteria defined radiological progression or other discontinuation criteria were met, but no more than 1 year).

Being tested
Durvalumab, Transcatheter Hepatic Arterial Chemoembolization (TACE), Ablation
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

    Also called IMFINZI

    Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1 and is being developed by AstraZeneca/MedImmune for use in the treatment of cancer.

  • Transcatheter Hepatic Arterial Chemoembolization (TACE)Procedure or surgery

    TACE techniques have been described in the NCCN and ESMO-ESDO guidelines, including cTACE and DEB-TACE.

  • AblationProcedure or surgery

    In this study, thermal ablation could be conducted with radiofrequency (RFA) or microwave (MWA).

Study groups in NCT04517227
Study groupRoleWhat they receive
single armExperimentalAll patients enrolled with receive the sequential therapy of TACE, ablation and durvalumab.
Receives: Drug: Durvalumab; Procedure: Transcatheter Hepatic Arterial Chemoembolization (TACE); Procedure: Ablation

What is being measured

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

  1. Adverse events

    safety

    Measured: From date of the first treatment until 90 days after the last treatment, assessed up to 21 months

  2. Serious adverse events

    safety

    Measured: From date of the first treatment until 90 days after the last treatment, assessed up to 21 months

  3. AEs of Special Interest

    safety

    Measured: From date of the first treatment until 90 days after the last treatment, assessed up to 21 months

  4. Discontinue rate caused by any AEs

    safety

    Measured: From date of the first treatment until date of the last treatment, assessed up to 18 months

Secondary outcomes (5)

  1. Progression-free survival (mRECIST) by IRRC

    efficacy

    Measured: From date of the first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  2. Time to progress (mRECIST) by IRRC

    efficacy

    Measured: From date of the first treatment until the date of first documented progression, assessed up to 36 months

  3. PFS rate at 12 months (mRECIST) by IRRC

    efficacy

    Measured: From date of the first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  4. PFS rate at 24 months (mRECIST) by IRRC

    efficacy

    Measured: From date of the first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  5. Overall survival

    efficacy

    Measured: From date of the first treatment to the date of death, assessed up to 36 months

Timeline

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

  1. First posted18 Aug 2020
  2. Study startJul 2021 (estimated)
  3. Primary completionJun 2025 (estimated)
  4. Study completionOct 2025 (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 N/A
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
NCT04517227
Sponsor's protocol ID
ESR-19-20285
Status last verified
Apr 2021
First submitted
14 Aug 2020
Last updated
3 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Durvalumab, Transcatheter Hepatic Arterial Chemoembolization (TACE) and Ablation in people with Hepatocellular Carcinoma, run by Fudan University.

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 12 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

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?

Adverse events (time frame: From date of the first treatment until 90 days after the last treatment, assessed up to 21 months). The study lists 4 primary outcomes in all. 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 NCT04517227.

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 3 May 2021.

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