Intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder cancer (GBC).
Conditions
Interventions
trail group:None
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age greater than 18 years at the time of first treatment with dulvalumab. 2. Histologically confirmed unresectable advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder cancer. 3. First-line treatment with combination of gemcitabine-based chemotherapy with or without TKIs; 4. The time of starting treatment (first treatment with durvalumab) is between April 2022 and May 2024. 5. Adequate organ bone marrow function tolerant of chemotherapy at baseline: 1) Hemoglobin >=8 g/dL 2) Absolute neutrophil count >=1.0 × 10^9/L 3) Platelet count >=50 × 10^9/L 4) ALT and AST <=5 × ULN, ALT and AST <=20 × ULN are allowed in patients with liver metastases.
Exclusion criteria
Exclusion criteria: 1. Received prior anti-cancer therapy (chemotherapy, targeted therapy, biologic therapy, or immune checkpoint inhibitors ICIs) for advanced BTC before durvalumab will be excluded. Except that chemotherapy or TKIs in first-line therapy prior to durvalumab within 1 month, which is regarded as concomitant treatment. 2. Enrolled in any interventional study for BTC first-line treatment, including TOPAZ-1, TopDouble, and so on. 3. History of previous or current, brain metastases or spinal cord compression (including asymptomatic and adequately treated disease). 4. Prior or existing malignancies.TOPAZ-1:NCT03875235. This is a Phase III TOPAZ-1 (D933AC00001) study tested durvalumab or placebo, in combination with SoC chemotherapy (GemCis) as a first line treatment for participants with advanced or metastatic BTC. TopDouble: NCT05924880 .This is a Phase IIIb, open-label, single arm, multicentre study assessing the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimen as first line therapy for uBTC (including IHCC, EHCC, GBC) in participants with WHO/ECOG PS of 0 to 2 at enrolment who are not eligible for locoregional therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real-world total survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactJun Zhou
Beijing Cancer Hospital
Outcome results
None listed