Phase II Study to Evaluate the Safety and Efficacy of Gemcitabine + Cisplatin + Durvalumab (MEDI4736) Treatment with Endoscopic Radiofrequency Ablation in Unresectable Biliary Tract Cancer with Biliary Obstruction - GCDR

Kitano Masayuki0 sites38 target enrollmentOctober 27, 2023

Overview

No summary available.

Registry

who.int

Start Date

October 27, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kitano Masayuki

•(1\) Patients who are at least 18 years of age at the time consent is obtained.
•(2\) Patients with histologically confirmed unresectable advanced or metastatic adenocarcinoma of the biliary system, including extrahepatic bile duct cancer and gallbladder cancer. However, papillary carcinoma is excluded.
•(3\) Patients who have undergone biliary drainage for obstructive jaundice due to biliary adenocarcinoma and whose serum bilirubin after drainage is less than 2\.0 times the upper limit of reference (ULN).
•Note that patients with a confirmed diagnosis of Gilbert's syndrome are eligible regardless of the serum bilirubin level, if the biliary obstruction that is clinically problematic has been cleared by biliary drainage.
•(4\) Patients with an expected prognosis of at least 3 months.
•(5\) Patients who can undergo transpapillary RFA.
•(6\)Patients with unresectable or metastatic disease at the time of initial diagnosis are eligible if they have untreated disease.
•(7\)If surgery is performed for curative purposes, patients who relapse more than 6 months later and, if applicable, more than 6 months after completion of postoperative adjuvant therapy (chemotherapy and/or radiation therapy) are eligible.
•(8\)Patients with a World Health Organization (WHO)/ECOG PS of 0 or 1\.
•(9\)Patients with one or more lesions identified as target lesions based on the new guidelines for determining response to treatment of solid tumors (RECIST), Version 1\.1\.

•(1\) Patients with ampullary tumors.
•(2\) Patients with Bismuth TYPE IV tumors or tumors located only in the intrahepatic bile duct.
•(3\) Patients with implanted cardiac pacemakers.
•(4\) Patients who have undergone Billroth II or Roux\-en\-Y reconstruction.
•(5\) Patients with a history of allogeneic organ transplantation.
•(6\) Patients with current or former autoimmune or inflammatory diseases (inflammatory bowel disease \[e.g., colitis or Crohn's disease]), diverticulitis except diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome or Wegener's syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) ) in confirmed patients.
•However, the following patients may be included.
•Patients with vitiligo or alopecia.
•Patients with hypothyroidism (e.g., after Hashimoto's disease) who are stable during hormone replacement therapy.
•Patients with chronic skin diseases that do not require systemic treatment.