Metastatic Breast Cancer in the LiverPhase 2Castle06(BC)NCT05303038
Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic TNBC Patients Failed by Multiline Therapy
A Phase 2 study testing Cryoablation Combined with Tirelizumab and Bevacizumab in people with Metastatic Breast Cancer in the Liver, run by Fudan University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer in the Liver
- What is being tested?
- Cryoablation Combined with Tirelizumab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2022to 1 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shangshai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, Professor, 86-021-64175590 ext. 88807, zhimingshao@yahoo.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Zhimin Shao, 86-021-64175590 ext. 88807, zhimingshao@yahoo.com
About this study
Official title: A Phase II Clinical Study of Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic Triple Negative Breast Cancer Patients Failed by Multiline Therapy
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.
Read the detailed description
This is a prospective, single-arm, single-center phase II clinical trial in liver metastatic triple-negative breast cancer patients failed by multiline therapy.
All subjects will receive cryoablation combined with tirelizumab + bevacizumab:
- Cryoablation of liver metastases: Cryoablation of 1-2 typical metastatic lesions will be performed on D1 under general anesthesia and ultrasound guidance for two cycles. If the patient has no measurable lesions outside the liver, the measurable lesions should be retained after partial ablation of the liver lesions.
- PD-1 antibody + anti vascular therapy: patients will receive 200mg Tirelizumab ( IV Q3W) + Bevacizumab 7.5mg/kg ( IV Q3W) at D14 after cryoablation until there is disease progression, intolerable toxic reaction, subject withdraws informed consent or the study ends (whichever comes first).
- Puncture biopsy of liver metastases will completed 1-3 days before cryoablation, 1-3 days before the first treatment with tirelizumab + bevacizumab, 2 cycles after treatment with tirelizumab + bevacizumab and after disease progression, and blood samples (about 10ml) were collected for mutation load detection and immune function evaluation.
- Conditions
- Metastatic Breast Cancer in the Liver
- Being tested
- Cryoablation Combined with Tirelizumab and Bevacizumab
- Keywords
- Triple Negative Breast Cancer, Cryoablation, Tirelizumab, Bevacizumab
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| cryoablation combined with tirelizumab + Bevacizumab | Experimental | Not described Receives: Combination Product: Cryoablation Combined with Tirelizumab and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months
Secondary outcomes (5)
Duration of Response (DOR)
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.
Measured: Up to 12 months
Disease Control Rate (DCR)
The proportion of participants who achieves a best overall response of CR, PR or stable disease(SD).
Measured: Up to 12 months
Progression-free Survival (PFS)
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Measured: Up to 12 months
One-year overall survival (OS) rate
OS defined as the time from the date of randomization to the date of death due to any reason. One-year survival rate (percentage of subjects alive at 1 year) was estimated from OS data.
Measured: Up to 12 months
Frequencies of Biomarkers
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 May 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer in the LiverStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303038
- Sponsor's protocol ID
- Castle06(BC)
- Acronym
- Castle06(BC)
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Cryoablation Combined With Tirelizumab and Bevacizumab in Liver Metastatic Triple Negative Breast Cancer Patients Failed by Multiline Therapy
- ClinicalTrials.gov ID
- NCT05303038
- Acronym / sponsor ID
- Castle06(BC) / Castle06(BC)
- Conditions
- Metastatic Breast Cancer in the Liver
- Keywords
- Triple Negative Breast Cancer, Cryoablation, Tirelizumab, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm, single-center phase II clinical trial in liver metastatic triple-negative breast cancer patients failed by multiline therapy.
All subjects will receive cryoablation combined with tirelizumab + bevacizumab:
- Cryoablation of liver metastases: Cryoablation of 1-2 typical metastatic lesions will be performed on D1 under general anesthesia and ultrasound guidance for two cycles. If the patient has no measurable lesions outside the liver, the measurable lesions should be retained after partial ablation of the liver lesions.
- PD-1 antibody + anti vascular therapy: patients will receive 200mg Tirelizumab ( IV Q3W) + Bevacizumab 7.5mg/kg ( IV Q3W) at D14 after cryoablation until there is disease progression, intolerable toxic reaction, subject withdraws informed consent or the study ends (whichever comes first).
- Puncture biopsy of liver metastases will completed 1-3 days before cryoablation, 1-3 days before the first treatment with tirelizumab + bevacizumab, 2 cycles after treatment with tirelizumab + bevacizumab and after disease progression, and blood samples (about 10ml) were collected for mutation load detection and immune function evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cryoablation combined with tirelizumab + Bevacizumab | Experimental | Combination Product: Cryoablation Combined with Tirelizumab and Bevacizumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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);
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation Combined with Tirelizumab and BevacizumabCryoablation 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. | Combination product | cryoablation combined with tirelizumab + Bevacizumab |
Primary outcome
ORR
Time frame: Up to 12 months
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).
5 secondary outcomes
Duration of Response (DOR)
Time frame: Up to 12 months
Disease Control Rate (DCR)
Time frame: Up to 12 months
Progression-free Survival (PFS)
Time frame: Up to 12 months
One-year overall survival (OS) rate
Time frame: Up to 12 months
Frequencies of Biomarkers
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Breast Cancer in the Liver
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
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 Disease
Metastatic Breast Cancer in the Liver
RecruitingPhase 1/2
SL-28 for Advanced Solid Tumours
Head & Neck Cancer, Pancreas Carcinoma
RecruitingPhase 1/2
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
Locally Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhimin Shao, Professor principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cryoablation Combined with Tirelizumab and Bevacizumab in people with Metastatic Breast Cancer in the Liver, run by Fudan University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, Professor (+86 021-6417559 ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.