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

STATUS

Recruiting
End date

Dec 30, 2023
participants needed

45
sponsor

Asan Medical Center

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Updated on 2 August 2021

See if I qualify

malignant disease

cancer

carcinoma

metastasis

pet scan

gemcitabine

carcinoma in situ

durvalumab

adenocarcinoma

cholangiocarcinoma

cisplatin/gemcitabine

gallbladder carcinoma

biliary tract cancer

gemcitabine/cisplatin

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.

Details

Condition	Gall Bladder Disorders, Malignant Adenoma, Biliary Tract Cancer, Biliary neoplasm, Malignant neoplasm of gallbladder, Gall Bladder Cancer, gallbladder cancer, Gallbladder Disease, Adenocarcinoma, Neoplasm of unspecified nature of digestive system, Cholangiocarcinoma, Gallbladder Carcinoma, Urothelial Tract Cancer, Digestive System Neoplasms
Treatment	Durvalumab + Gem/Cis, Gem/Cis
Clinical Study Identifier	NCT04308174
Sponsor	Asan Medical Center
Last Modified on	2 August 2021

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Eligibility		Yes	No	Not Sure
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
	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

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Study Definition

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