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Biliary Tract NeoplasmsPhase 2DEBATENCT04308174

Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer

A Phase 2 study testing Durvalumab + Gem/Cis and Gem/Cis in people with Biliary Tract Neoplasms and Gallbladder Cancer, run by Asan Medical Center at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Considering that the poor prognosis of resected biliary tract cancer and negative impact on the survival outcomes of R1/R2 resection, neoadjuvant chemotherapy may improve R0 resection rates and the survival outcomes of patients with resectable biliary tract cancer. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Durvalumab + Gem/Cis and Gem/Cis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSouth Korea
Study dates
20 May 2020to 30 Dec 2025
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 19 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.
  • Age > 19 years at time of study entry
  • Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma, or gallbladder carcinoma).
  • Localized, potentially resectable, non-metastatic disease (determined at the discretion of attending surgeons) based on the results of CT, MRI or PET-CT scans.
  • No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy.
  • Eastern Cooperative Oncology Group (ECOG performance status of 0 or 1
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  • Body weight >30kg
  • Adequate normal organ and marrow function
  • 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.
  • No other malignant disease apart from non-melanotic skin cancer, carcinoma in situ of the uterine cervix, localized prostate or papillary thyroid cancer, or any other cancer where treated with curative intent > 5 years previously without evidence of relapse

Who cannot join

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
  • Obstruction of gastrointestinal tract
  • Active gastrointestinal bleeding
  • Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
  • Combined hepatocellular carcinoma/cholangiocarcinoma is excluded.
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  • History of allogenic organ transplantation.
  • 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
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
  • 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.
  • Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: Randomized Phase 2 Study of Preoperative Gemcitabine Plus Cisplatin With or Without Durvalumab (MEDI4736) Followed by Postoperative Durvalumab (MEDI4736) in Patients With Localized Biliary Tract Cancer

Considering that the poor prognosis of resected biliary tract cancer and negative impact on the survival outcomes of R1/R2 resection, neoadjuvant chemotherapy may improve R0 resection rates and the survival outcomes of patients with resectable biliary tract cancer. The addition of durvalumab to gemcitabine/cisplatin as neoadjuvant chemotherapy may improve the R0 resection rates compared to gemcitabine/cisplatin in patients with localized biliary tract cancer. In this phase 2 trial, a total of 45 patients with localized biliary tract cancer will be 2:1 randomized to durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin.

Being tested
Durvalumab + Gem/Cis, Gem/Cis
Keywords
Biliary tract cancer, Immunotherapy, Neoadjuvant chemotherapy
Medical subject headings
Biliary Tract Neoplasms, Gallbladder Neoplasms, Cholangiocarcinoma

What participants receive

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

  • Durvalumab + Gem/CisDrug

    Neoadjuvant Durvalumab + Gemcitabine/Cisplatin

  • Gem/CisDrug

    Neoadjuvant Gemcitabine/Cisplatin

Study groups in NCT04308174
Study groupRoleWhat they receive
Durvalumab + Gem/CisExperimental<Investigational arm: preoperative phase (up to 4 cycles)> Durvalumab 1,500 mg IV on Day 1, every 3 weeks (preop period) 1,500 mg IV Day 1, every 4 weeks (postop period) Gemcitabine 1,000 mg IV on Day 1 and 8, every 3 weeks Cisplatin 25 mg IV on Day 1 and 8, every 3 weeks <Postoperative therapy for all patients (up to 6 cycles)> Durvalumab 1,500 mg IV Day 1, every 4 weeks (postop period)
Receives: Drug: Durvalumab + Gem/Cis
Gem/CisActive comparator<Control arm: preoperative phase (up to 4 cycles)> Gemcitabine 1,000 mg IV on Day 1 and 8, every 3 weeks Cisplatin 25 mg IV on Day 1 and 8, every 3 weeks <Postoperative therapy for all patients (up to 6 cycles)> Durvalumab 1,500 mg IV Day 1, every 4 weeks (postop period)
Receives: Drug: Gem/Cis

What is being measured

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

  1. Ro resection rate

    Surgical resection without any residual cancer

    Measured: 4 months

Secondary outcomes (4)

  1. Overall survival

    Time between the start of study treatment and any cause of death

    Measured: 1 year

  2. Event-free survival

    Time between the start of study treatment and disease progression or any cause of death

    Measured: 1 year

  3. Adverse events

    Number of patients experiencing adverse events graded by National Cancer Institute Common Terminology Criteria version 5

    Measured: 13 months

  4. Response rate

    Graded by Response Evaluation Criteria in Solid Tumors version 1.1

    Measured: 4 months

Timeline

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

  1. First posted13 Mar 2020
  2. Study start20 May 2020
  3. Primary completion30 Jun 2023
  4. Study completion30 Dec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04308174
Sponsor's protocol ID
ESR-18-14059
Acronym
DEBATE
Status last verified
Jan 2025
First submitted
12 Mar 2020
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD sharing plan will be determined at the time of completion of the study.

Publications

  • Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

    PubMed 20375404

  • Kang J, Jeong JH, Hwang HS, Lee SS, Park DH, Oh DW, Song TJ, Kim KH, Hwang S, Hwang DW, Kim SC, Park JH, Hong SM, Kim KP, Ryoo BY, Yoo C. Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response. Cancer Res Treat. 2020 Apr;52(2):594-603. doi: 10.4143/crt.2019.493. Epub 2019 Dec 18.

    PubMed 32019287

  • Valle JW, Borbath I, Khan SA, Huguet F, Gruenberger T, Arnold D; ESMO Guidelines Committee. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v28-v37. doi: 10.1093/annonc/mdw324. No abstract available.

    PubMed 27664259

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab + Gem/Cis and Gem/Cis in people with Biliary Tract Neoplasms and Gallbladder Cancer, run by Asan Medical Center at 1 site in South Korea.

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 10 inclusion and 15 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 28 Jan 2025. 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 South Korea. 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?

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?

Ro resection rate (time frame: 4 months). 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 NCT04308174, which also lists 3 linked publications.

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 28 Jan 2025.

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