A multicenter prospective observational study on the clinical outcomes of patients with biliary tract cancer treated by systemic chemotherapy in combination with immune checkpoint inhibitors

A multicenter prospective observational study on the clinical outcomes of patients with biliary tract cancer treated by systemic chemotherapy in combination with immune checkpoint inhibitors - An observational study on systemic chemotherapy with ICI for biliary cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056779

Enrollment

250

Registered

2025-02-10

Start date

2025-02-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed with unresectable biliary tract cancer, including intrahepatic cholangiocarcinoma, hilar bile duct cancer, and distal bile duct cancer, gallbladder cancer or ampullary cancer. 2) Pathologically confirmed as adenocarcinoma or adenosquamous carcinoma. In cases of postoperative recurrence, if the surgical specimen already provided a pathological diagnosis, the pathological diagnosis for the recurrent lesion is not required. 3) Received no prior chemotherapy for biliary tract cancer. The patients who were treated with S-1 as postoperative adjuvant chemotherapy remain eligible. 4) Received no prior history of radiotherapy for biliary tract cancer. The patients who have received palliative radiation for bone metastases for pain control remain eligible. 5) Over 20 years old 6) Provided written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1) With a malignancy of other organ that could influence prognosis. 2) Received any chemotherapy for other malignancy at the time of enrollment. 3) Received prior treatment with ICIs including of antiPD1, antiPDL1, antiPDL2 or antiCTLA4 antibodies, therapy of Tcell regulatory antibodies or vaccine therapy. 4) Judged to be unsuitable for the participant this study by investigator or sub-investigator.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Gem + CDDP in combination with durvalumab or pembrolizumab and investigate the factors associated with treatment outcomes To investigate the frequency and the characteristics of immune related adverse events	—

Secondary

Measure	Time frame
1) To investigate the frequency of genetic test in biliary tract cancer and its impact on treatment efficacy 2) To evaluate the treatment efficacy and safety by regimen in second-line and later-line therapies 3) To investigate the frequency and the characteristics of the adverse events other than irAEs 4) To investigate the factors associated with the occurrence of irAEs 5) To investigate the correlation between the occurrence of irAEs and survival.	—

Measure

Time frame

1) To investigate the frequency of genetic test in biliary tract cancer and its impact on treatment efficacy 2) To evaluate the treatment efficacy and safety by regimen in second-line and later-line therapies 3) To investigate the frequency and the characteristics of the adverse events other than irAEs 4) To investigate the factors associated with the occurrence of irAEs 5) To investigate the correlation between the occurrence of irAEs and survival.

—

Countries

Japan

Contacts

Public ContactTeppei Yoshioka

Osaka University Graduate School of medicine Gastroenterology and Hepatology

teyoshioka@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results