Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer
Sponsor study identifier
interventional
37
1 country
1
Study Start
August 1, 2020
Actual (reported)Primary Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Conversion rate; Secondary endpoints: Safety, disease control rate, disease-free survival, and overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab; Sample size: 34 patients; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 3 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 4.0; Follow up: 12 months after the last case was enrolled.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2020
Actual (reported)July 26, 2021
Actual (reported)August 2, 2021
Actual (reported)July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
objective response rate
objective response rate
3 weeks
Safety：the incidence of adverse events and serious adverse events
3 weeks
disease control rate
3 weeks
progress-free survival
3 weeks
overall survival
3 weeks
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab Gemcitabine: 1000mg/m\^2, iv, d1, d8, q3w Oxaliplatin: 100mg/m\^2, iv, d1, q3w Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 5mg/kg, d1, q3w
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordFudan University Shanghai Cancer Center
Shanghai, 200032, China
37 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2021
First Posted
August 2, 2021
Study Start
August 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 26, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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