NCT05303038

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 9, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

March 21, 2022

Last Update Submit

June 6, 2022

Conditions

Metastatic Breast Cancer in the Liver

Keywords

Triple Negative Breast CancerCryoablationTirelizumabBevacizumab

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

Study Arms (1)

cryoablation combined with tirelizumab + Bevacizumab

EXPERIMENTAL
Combination Product: Cryoablation Combined with Tirelizumab and Bevacizumab

Interventions

Cryoablation Combined with Tirelizumab and BevacizumabCOMBINATION_PRODUCT

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.

cryoablation combined with tirelizumab + Bevacizumab

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fudan University Shangshai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Zhimin Shao, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, Professor

CONTACT

+86 021-6417559zhimingshao@yahoo.com

Lei Fan, Dr

CONTACT

+86 021-6417559teddyfl@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

May 1, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

June 9, 2022

Record last verified: 2022-04

Locations

CN(2)