biliary tract cancer biliary tract cancer
Conditions
Interventions
GCD therapy with GC reintroduction
GCD therapy (every 3 weeks)
GEM 1000 mg/m2, CDDP 25 mg/m2, durvalumab 1500 mg/body, Day 1
GEM 1000 mg/m2, CDDP 25 mg/m2, Day 8 and onwards, continued until intoleran
Sponsors
Sunakawa Yu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with unresectable or recurrent BTC. Patients with recurrent BTC who received adjuvant chemotherapy are eligible if the duration from the last day of adjuvant chemotherapy to the confirmation date of recurrence is at least 24 weeks (those having recurrence on the same day of the week 24 weeks after the last day of chemotherapy are considered eligible). The presence or absence and details of neoadjuvant chemotherapy do not matter. 2) Patients who became refractory to first line treatment with GCD, during durvalumab monotherapy maintenance at least 1 cycle, after completing at least 8 doses of CDDP. Refractory intolerance to first line treatment with GCD is defined by RECIST PD or clinical PD. 3) Diagnosis of BTC (adenocarcinoma) by histological or cytological examination of primary or metastatic lesions. 4) Diagnosis of unresectable disease by chest CT and abdominal/pelvic CT, or abdominal/pelvic MRI. 5) Aged at least 18 years on the enrollment date. 6) The body weight at enrollment exceeds 30 kg. 7) Performance status (PS) based on the Eastern Cooperative Oncology Group (ECOG) scale is 0 or 1. 8) Oral intake is possible. 9) The most recent laboratory values within 14 days prior to enrollment meet all the following criteria (laboratory tests on the same day of the week two weeks prior to the date of enrollment are acceptable): (1) A neutrophil count of >=1,500/mm3 (2) Hemoglobin of >=8.0 g/dL (3) A platelet count of 7.5*104/mm3 (4) Total bilirubin of 40 mL/min, or an estimated CCr of >40 mL/min by either Cockcroft-Gault formula or a 24-hour urine collection for measurement of CCr 10) Life expectancy is expected to be more than 3 months. 11) Written informed consent to participate in the study has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Patients having experienced allergy or hyperreactivity to any of GEM, CDDP and durvalumab, or Grade 4 non-hematological toxicity (excluding laboratory abnormalities posing no clinical problems) with causal relationship to any of GEM, CDDP and durvalumab during the first-line treatment. Patients with Grade 2 or 3 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician 2) Patients having active double cancers (double cancers that do not have a defined prognosis and do not require aggressive treatment, such as early-stage cancers, are allowed). 3) Patients having infection requiring systemic treatment (excluding viral hepatitis). 4) Patients having undergone major surgery* (based on the judgement by the Investigator or Sub-investigator) within 28 days before enrollment. *Local operation on isolated lesions for palliative purposes is acceptable. 5) Patients having metastasis to the central nervous system (brain, spinal cord, meninges) (Brain CT or MRI before enrollment is not indispensable). 6) Patients having treatment-resistant moderate or severer ascites and/or moderate or severer pleural effusion. 7) Patients having severe lung disease (including interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema). 8) 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. 9) Patients having complication by psychiatric illness or symptoms and judged as difficult to participate in the study. 10) Patients having serious complication(s) (poorly controlled diabetes mellitus, poorly controlled hypertension, heart failure of NYHA class III or IV, renal failure, hepatic failure, hemorrhagic peptic ulcer, ileus, etc.). 11) Patients currently receiving immunosuppressor(s) or having received immunosuppressor(s) within 14 days before the first dose of durvalumab. However, patients having received the following doses are eligible: (1) Intranasal, inhalation or topical steroid dose, or local steroid injection (e.g., intraarticular injection) (2) Systemic corticosteroid dose at a physiological dose level equivalent to <=10 mg prednisone/day. (3) Steroid dose as premedication for control of hyperreactivity (e.g., premedication for CT scan). 12) Patients having developed severe arterial thromboembolism (myocardial infarction, unstable angina, cerebral infarction) within 6 months before the start of protocol treatment. 13) Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: (1) Patients with vitiligo or alopecia (2) Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement (3) Any chronic skin condition that does not require systemic therapy (4) Patients without active disease in the last 5 years may be included but only after consultation with the study physician (5) Patients with celiac disease controlled by diet alone 14) Any concurrent chemotherapy, IP, or biologic, for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. 15) H
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), progression-free survival (PFS), response rate, disease control rate (DCR), duration of response (DOR), and incidence rate of adverse events (AEs) | — |
Contacts
Public ContactKumiko Umemoto
St. Marianna University Hospital
Outcome results
None listed