Castle06(BC)
A Phase II Clinical Study of Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic Triple Negative Breast Cancer Patients Failed by Multiline Therapy
Sponsor study identifier
interventional
15
1 country
2
Study Start
May 1, 2022
Actual (reported)Primary Completion
April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a Phase II, open-label study evaluating the efficacy and safety of Cryoablation combined with Tirelizumab and Bevacizumab in liver metastatic triple-negative breast cancer patients failed by multiline therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 21, 2022
Actual (reported)March 31, 2022
Actual (reported)May 1, 2022
Actual (reported)April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
ORR
The number of people with tumor responses according to RECIST (V1.1): the proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR).
Up to 12 months
Duration of Response (DOR)
Up to 12 months
Disease Control Rate (DCR)
Up to 12 months
Progression-free Survival (PFS)
Up to 12 months
One-year overall survival (OS) rate
Up to 12 months
Frequencies of Biomarkers
Up to 12 months
Cryoablation of 1-2 typical metastatic lesions will be performed on D1 under general anesthesia and ultrasound guidance for two cycles. 200mg Tirelizumab ( IV Q3W) + Bevacizumab 7.5mg/kg ( IV Q3W) will be administered at D14 after cryoablation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Cryoablation Combined with Tirelizumab and Bevacizumab
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordFudan University Shangshai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Fudan University Shanghai Cancer Center
Shanghai, China
Zhimin Shao, Professor
Fudan University
First Submitted
March 21, 2022
First Posted
March 31, 2022
Study Start
May 1, 2022
Actual (reported)Primary Completion
April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 9, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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