Unresectable biliary tract cancer
Conditions
Interventions
For patients with unresectable biliary tract cancer with biliary tract obstruction, eligibility will be determined during the screening period after obtaining written informed consent from the patient
Sponsors
Kitano Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who were 18 years of age or older at the time consent was obtained. (2) Patients with histologically confirmed unresectable biliary tract adenocarcinoma. (3) Patients who underwent biliary drainage for biliary obstruction caused by biliary tract adenocarcinoma, and whose post-drainage serum bilirubin is = 9.0 g/dL b. Absolute neutrophil count >= 1,500/microliter c. Platelet count >= 100,000/microliter d. ALT and AST 30 kg (13) Patients capable of adhering to the requirements and restrictions outlined in the informed consent document and this study protocol, and who have signed the informed consent document in their own handwriting.
Exclusion criteria
Exclusion criteria: (1) Patients with an implanted cardiac pacemaker. (2) Patients with a history of another primary malignant tumor. However, the following are excluded: a. Malignant tumors treated with curative intent, with no evidence of activity for at least 5 years prior to the start of this trial treatment and a low risk of recurrence. b. Skin cancer other than melanoma or malignant nevus that has been adequately treated and shows no evidence of disease. c. Adequately treated carcinoma in situ with no evidence of disease. (3) Patients with brain metastases or spinal cord compression (including asymptomatic disease and disease that has received appropriate treatment). For patients suspected of having brain metastases at screening, perform brain MRI (recommended) or CT (both preferably with intravenous contrast) prior to enrollment. (4) Patients with known allergy or hypersensitivity to gemcitabine, cisplatin, immune checkpoint inhibitors, or their additives. (5) Patients concurrently receiving any chemotherapy, investigational drug administration, biological therapy, or hormone therapy for cancer treatment. However, concurrent hormone therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is permissible. (6) Patients who received radiation therapy, including palliative radiation therapy, prior to enrollment. (Excluding radiation therapy administered as adjuvant therapy after surgery.) (7) Patients currently using immunosuppressants or who plan to use them within 14 days prior to the first study drug dose. However, the following are acceptable: a. Administration of intranasal steroids, inhaled steroids, or topical steroids, or local steroid injections (e.g., intra-articular injections). b. Administration of physiologically dosed systemic corticosteroids not exceeding prednisone 10 mg/day or equivalent steroids. c. Steroids administered as premedication for hypersensitivity reactions (e.g., premedication for CT scans). (8) Patients enrolled in another clinical trial concurrently with this study, except during observation (non-interventional) clinical trials or the follow-up period of an interventional trial. (9) Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are unwilling to use effective contraception from screening until 90 days after the final dose. (10) Patients with active HBV infection (hepatitis B). (11) Patients who demonstrate detectable HCV RNA at the testing facility of each study site and are determined to have active HCV infection. Note: Patients with positive HCV antibody test results but undetectable HCV RNA are eligible for inclusion. (12) Patients deemed by the principal investigator (or sub-investigator) to be unable to comply with the study procedures, restrictions, and requirements, and therefore unsuitable for participation. (13) Patients deemed by the principal investigator (or sub-investigator) to be ineligible for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Overall response rate (ORR) Duration of response (DOR) Time to recurrent biliary obstruction (TRBO) Incidence of severe adverse events (SAE) Incidence of RFA complications Incidence of GCI side effects (CTCAE version 5.0 Grade 3 or higher) | — |
Contacts
Public ContactYasunobu Yamashita
Wakayama Medical University Hospital
Outcome results
None listed