A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

JRCT ID: jRCT2031230509

Registered date:13/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary Tract Cancer
• Date of first enrollment: 13/12/2023
• Target sample size: 750
• Countries of recruitment: Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Denmark,Japan,Finland,Japan,Germany,Japan,India,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,UK,Japan,USA,Japan,China,Japan,Hong Kong,Japan
• Study type: Interventional

Intervention(s)

Drug: Rilvegostomig IV (intravenous)
Drug: Placebo IV (intravenous)
Drug: Gemcitabine/Cisplatin IV (Intravenous)
Drug: S-1 [Tegafur/Oteracil/gimeracil] (Oral)

Outcome(s)

Primary Outcome

Recurrence free survival (RFS) for Arm A vs. Arm B [ Time Frame: Approximately 5 years ]
Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)

- Provision of a tumor sample collected at surgical resection.

- Randomization within 12 weeks after resection with adequate healing and removal of drains.

- Confirmed to be disease-free by imaging within 28 days prior to randomization.

- Eastern Cooperative Oncology Group performance status of 0 or 1

Exclude criteria

- Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.

- Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.

- Any anti-cancer therapy for BTC prior to surgery

- Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease

- Current or prior use of immunosuppressive medication within 14 days before the first dose

- Thromboembolic event within 3 months

- Active HBV or HCV infection unless treated.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06109779