Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
- Conditions
- Biliary Tract Neoplasms
- Registration Number
- NCT03875235
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion<br><br> 1. Histologically confirmed, unresectable advanced or metastatic biliary tract,<br> including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder<br> carcinoma.<br><br> 2. Patients with previously untreated disease if unresectable or metastatic at initial<br> diagnosis will be eligible.<br><br> 3. Patient with recurrent disease >6 months after curative surgery or >6 months after<br> the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.<br><br> 4. WHO/ECOG PS of 0 or 1<br><br>Exclusion<br><br> 1. History of another primary malignancy<br><br> 2. Brain metastases or spinal cord compression<br><br> 3. Uncontrolled intercurrent illness<br><br> 4. Major surgical procedure within 28 days prior to the first dose of IP.<br><br> 5. Prior locoregional therapy such as radioembolization
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS);Overall Survival (OS) Rate at 18 Months;Overall Survival (OS) Rate at 24 Months
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS);Progression-free Survival (PFS) Rate at 9 Months;Progression-free Survival (PFS) Rate at 12 Months;Objective Response Rate (ORR);Duration of Response (DoR);Duration of Response (DoR): Percentage Remaining in Response at 9 Months;Duration of Response (DoR): Percentage Remaining in Response at 12 Months;Disease Control Rate (DCR) - Overall;Disease Control Rate (DCR) - 24 Weeks;Disease Control Rate (DCR) - 32 Weeks;Disease Control Rate (DCR) - 48 Weeks