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

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ClinicalTrials.gov Identifier: NCT04308174
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : July 22, 2021
Sponsor:
Collaborator:
Samsung Medical Center
Information provided by (Responsible Party):
Changhoon Yoo, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE March 12, 2020
First Posted Date  ICMJE March 13, 2020
Last Update Posted Date July 22, 2021
Actual Study Start Date  ICMJE May 20, 2020
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
Ro resection rate [ Time Frame: 4 months ]
Surgical resection without any residual cancer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
  • Overall survival [ Time Frame: 1 year ]
    Time between the start of study treatment and any cause of death
  • Event-free survival [ Time Frame: 1 year ]
    Time between the start of study treatment and disease progression or any cause of death
  • Adverse events [ Time Frame: 13 months ]
    Number of patients experiencing adverse events graded by National Cancer Institute Common Terminology Criteria version 5
  • Response rate [ Time Frame: 4 months ]
    Graded by Response Evaluation Criteria in Solid Tumors version 1.1
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
  • Overall survival [ Time Frame: 1 year ]
    Time between the start of study treatment and any cause of death
  • Event-free survival [ Time Frame: 1 year ]
    Time between the start of study treatment and disease progression or any cause of death
  • Adverse events [ Time Frame: 13 months ]
    Graded by National Cancer Institute Common Terminology Criteria version 5
  • Response rate [ Time Frame: 4 months ]
    Graded by Response Evaluation Criteria in Solid Tumors version 1.1
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer
Official Title  ICMJE 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
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Biliary Tract Neoplasms
  • Gallbladder Cancer
  • Cholangiocarcinoma
Intervention  ICMJE
  • Drug: Durvalumab + Gem/Cis
    Neoadjuvant Durvalumab + Gemcitabine/Cisplatin
  • Drug: Gem/Cis
    Neoadjuvant Gemcitabine/Cisplatin
Study Arms  ICMJE
  • Experimental: Durvalumab + Gem/Cis

    <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)

    Intervention: Drug: Durvalumab + Gem/Cis
  • Active Comparator: Gem/Cis

    <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)

    Intervention: Drug: Gem/Cis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2020)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.
  • History of allogenic organ transplantation.
  • History of another primary malignancy except for

    1. 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
    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    3. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Changhoon Yoo, MD, PhD +821099006798 yooc@amc.seoul.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04308174
Other Study ID Numbers  ICMJE ESR-18-14059
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD sharing plan will be determined at the time of completion of the study.
Responsible Party Changhoon Yoo, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Samsung Medical Center
Investigators  ICMJE
Principal Investigator: Changhoon Yoo, MD, PhD Asan Medical Center
PRS Account Asan Medical Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP