advanced biliary tract cancer
Conditions
Interventions
GCS group
The GCS regimen comprised gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2) infusion on day 1 and 80 mg/m2 of S- 1 on days 1- 7 every 2 weeks.
B group
GCD group
Durvalumab combined with gemcitabine and cisplatin was administered intravenously on a 21-day cycle for up to eight cycles. Durvalumab (1500 mg) was administered on day 1 of each cycle, in combination
Sponsors
Yamaguchi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically diagnosed adenocarcinoma or adenosquamous carcinoma. 2) Diagnosis of unresectable or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, hilar bile duct cancer, distal cholangiocarcinoma, gallbladder cancer, or papillary carcinoma) by imaging diagnosis 3) No prior systemic chemotherapy or radiation therapy for biliary tract cancer. However, in the case of postoperative adjuvant chemotherapy for biliary tract cancer, patients are eligible if at least 6 months have passed since the date of the last dose (recurrence on the same date 6 months after the last dose is acceptable). In the case of recurrent biliary tract cancer, any neoadjuvant chemotherapy given prior to resection is not questioned. 4) Total bilirubin < 2.9 mg/dL 5) Patients must be at least 20 years of age at the time of enrollment. 6) Patients must have a performance status (PS) of 0 or 1 according to the ECOG criteria at the time of enrollment (PS must be documented in the medical record). 7) Patients must be able to take oral intake. 8) The latest laboratory values within 14 days prior to enrollment (the same day of the week prior to enrollment is acceptable) meet all of the following criteria: Neutrophil count > 1,500/mm3 Hemoglobin > 8.5 g/dL Platelet count >100,000/mm3 AST <150 IU/L ALT<150 IU/L Creatinine <1.2 mg/dL 9) Written consent to participate in the study has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Patients who have undergone curative resection with positive pathology margin. 2) Have active overlapping cancers (overlapping cancers that do not define the prognosis and do not require aggressive treatment, such as early-stage cancer, are acceptable). 3) Infectious diseases (excluding viral hepatitis) requiring systemic treatment. Especially, patients with biliary stasis should be enrolled after appropriate drainage and proper control of cholangitis. 4) Patients with a fever of 38 degrees Celsius. or higher at the time of enrollment. 5) Women who are pregnant, possibly pregnant, or lactating. Males who wish to have a partner who is pregnant. 6) Patients with psychiatric disorders or psychiatric symptoms that interfere with their daily life or make it difficult for them to give their consent, difficulty in participating in the research. 7) Receiving continuous systemic administration of steroids (prednisone equivalent > 10 mg/day) or other immunosuppressive drugs for the treatment of autoimmune or other diseases. 8) Complicated by serious complications (heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction). 9) Complicated with poorly controlled diabetes mellitus (if controlled prior to enrollment, the patient may be enrolled). 10) Complicated with unstable angina pectoris or a history of myocardial infarction within 6 months prior to enrollment. 11) Complicated interstitial pneumonia, pulmonary fibrosis, or severe emphysema, as diagnosed by CT scan of the chest. 12) Requires continued use of flucytosine, phenytoin, or warfarin potassium. 13) Patient has metastatic disease to the central nervous system (pretreatment head CT/MRI scan not required). 14) Patients with a history of hypersensitivity to any component of the study drug or any other condition that is contraindicated. 15) Patients with water diarrhea 16) Other conditions that the physician deems inappropriate for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Countries
Japan
Contacts
Public ContactTakeshi Terashima
Kanazawa University Hospital Department of Gastroenterology
Outcome results
None listed