Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic TNBC Patients Failed by Multiline Therapy
- Sponsor
- Fudan University
- Study ID
- NCT05303038
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Metastatic Breast Cancer in the Liver
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cryoablation Combined with Tirelizumab and Bevacizumab — COMBINATION_PRODUCTCryoablation 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.
Study Details
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.
Key Dates
- First listed
- Mar 31, 2022
- Start date
- May 1, 2022
- Status verified
- Apr 2022
- Primary completion
- Apr 1, 2024
- Completion
- Apr 1, 2024
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: cryoablation combined with tirelizumab + Bevacizumab
Primary Outcome Measure
ORR [ Time Frame: Up to 12 months ]
Central Contacts
- Zhimin Shao, Professor+86 021-6417559
- Lei Fan, Dr+86 021-6417559
Related Studies
- Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant DiseasePHASE2 · Recruiting · Delcath Systems Inc. · Tampa, Florida