Clinical trial · Interventional
Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic TNBC Patients Failed by Multiline Therapy
A Phase II Clinical Study of Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic Triple Negative Breast Cancer Patients Failed by Multiline Therapy
NCT05303038CI-TRIAL-00058984Castle06(BC)unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer in the Liver | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation Combined with Tirelizumab and Bevacizumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cryoablation combined with tirelizumab + Bevacizumab
- interventionNames
- Combination Product: Cryoablation Combined with Tirelizumab and Bevacizumab
Primary outcomes (1)
- measure
- ORR
- timeFrame
- Up to 12 months
- description
- 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).
Secondary outcomes (5)
- measure
- Duration of Response (DOR)
- timeFrame
- Up to 12 months
- description
- The time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or Imageologically confirmed liver metastatic tnbc patients; * Histologically confirmed diagnosis of TNBC characterized by estrogen receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-); * ≥ 2 prior lines systemic therapy; * Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); * The patients show no signs of bile duct obstruction, and the bilirubin is below the upper limit of 1.5x normal value (ULN); * Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place); * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * The functions of the patient's organs and blood system meet the requirements; * Blood system function: absolute neutrophil count (ANC) ≥ 1.5 x 109 / L, platelet count ≥ 100 x 109 / L * Renal function: estimated glomerular filtration rate or creatinine clearance \> 50 ml / min / 1.73 M2 * Liver function: total bilirubin ≤ 1.5 x ULN, AST and alt ≤ 5 x ULN * Estimated survival time ≥12 weeks. Exclusion Criteria: * The patient is currently receiving or has received irradiation or local treatment for the target lesion in the past 3 weeks. * The patient had previously received cryoablation. * The patient received major surgery within 14 days before enrolling in the study. * Palliative radiotherapy must be completed at least 2 weeks before enrolling in the study, and there is no plan for additional radiotherapy for the same lesion; ·Patients whose AE caused by radiotherapy did not recover to ≤ CTCAE 1 degree * The patient had metastatic brain lesions, including asymptomatic and well controlled lesions. * Complicated with infection and requiring intravenous antibiotic treatment. * The patient has any clinically significant disease or history that the investigator believes may endanger the safety of the patient or the reliability of the study results. * The patient has a history of any other malignancy unless the remission period exceeds 1 year. (do not exclude skin cancer, cervical cancer in situ, superficial bladder cancer, and breast cancer in radical treatment). * Female patients are pregnant or breastfeeding. * The patient received any trial drug within 14 days before receiving the first study drug. * The patient had undiminished or unstable severe toxicity (≥ CTCAE 4.0 grade 2) after previous use of another trial drug and / or previous cancer treatment, except anemia, weakness and hair loss. * Patients are allergic to the test drug or any of its excipients. * Patients are known to be HIV positive, have HCB, or have HBV infection and HBV DNA exceeds 2000 IU / ml. * The patient has a known history of drug addiction in the past 1 year, because this situation may lead to a high risk of non-compliance of the trial drug. * The patient has known active or suspected autoimmune disease. Subjects who are in a stable state and do not need systemic immunosuppressive therapy are allowed to be enrolled. * Subjects requiring systemic treatment with corticosteroids (\> 10mg / day prednisone efficacy dose) or other immunosuppressants within 14 days before the administration of the study drug were allowed to inhale or locally use steroids and adrenal hormone replacement with a dose \> 10mg / day prednisone efficacy dose in the absence of active autoimmune diseases. * The patient had a baseline corrected QT interval QTc \> 450 ms, or the patient had known QT prolongation syndrome, torsade de pointe ventricular tachycardia, symptomatic ventricular tachycardia, unstable heart syndrome within 3 months before the screening visit, \> grade 2 New York Heart Association heart failure, \> grade 2 Canadian Cardiovascular Association angina pectoris.
References
Publications (0)
Data not yet available
No reference posted for this study.