Biliary Tract Cancer
Conditions
Keywords
Adenocarcinoma of the biliary tract, Biliary tract Cancer, Gall bladder cancer, Intrahepatic Cholangiocarcinoma, Distal Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Klatskin Tumors, Bile duct cancer, Immunotherapy, Cholangiocarcinoma, Rilvegostomig, S-1, Gemcitabine/cisplatin, Capecitabine
Brief summary
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
Detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.
Interventions
DRUGRilvegostomig
Rilvegostomig IV (intravenous) Q3W
DRUGPlacebo
Placebo IV (intravenous) Q3W
DRUGCapecitabine
Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice
Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle
DRUGS-1 [Tegafur/Oteracil/gimeracil]
S-1 \[Tegafur/Oteracil/gimeracil\] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind masking
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence free survival (RFS) for Arm A vs. Arm B | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) for Arm A vs. Arm B | up to 7 years | Overall survival is defined as the time from randomization until the date of death due to any cause. |
Countries
Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Norway, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed