Hepatic Artery InfusionPhase 2NCT07284836
Phase II Trial of Albumin-Bound Paclitaxel Combined With Nedaplatin (TP) Via Hepatic Arterial Infusion for Advanced Breast Cancer Patients With Liver Metastases After Failure of Standard Therapy
A Phase 2 study testing Abraxane and Nedaplatin in people with Hepatic Artery Infusion and Liver Metastasis of Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Study Objective: To Evaluate the Efficacy of Albumin-Bound Paclitaxel Combined with Nedaplatin via Hepatic Arterial Infusion as Later-Line Therapy for Breast Cancer Patients with Liver Metastases After Failure of Standard Treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Hepatic Artery Infusion, Liver Metastasis of Breast Cancer
- What is being tested?
- Abraxane and Nedaplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients with liver metastases from breast cancer pathologically confirmed via surgery or biopsy.
- Advanced breast cancer patients with imaging-confirmed visceral tumor burden solely confined to liver metastases.
- Patients who have previously failed at least two lines of standard therapy (including endocrine therapy, chemotherapy, or targeted therapy), or those for whom researchers determine that local therapy would yield greater benefit.
- Age 18-70 years.
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2. • 0: Fully active, without any restrictions; • 1: Restricted in physically strenuous activity but ambulatory and able to carry out light work; • 2: Ambulatory and capable of all self-care but unable to carry out any work activities.
- Liver function score (e.g., Child-Pugh) Class A-B.
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- Class A (5-6 points): Good hepatic reserve, well tolerated to surgery, low incidence of postoperative complications and mortality;
- Class B (7-9 points): Moderately impaired hepatic reserve, poorly tolerated to surgery, increased postoperative complications and mortality;
- Class C (≥10 points): Severely impaired hepatic reserve, very poorly tolerated to surgery, high risk of postoperative complications and mortality; surgery is generally not recommended.
- ⑦ Adequate organ function.
- Hemoglobin ≥90 g/L, white blood cells ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L;
- Serum creatinine ≤1.0×upper normal limit (UNL), and creatinine clearance >60 mL/min;
- Alanine aminotransferase (ALT) ≤1.5×UNL, aspartate aminotransferase (AST) ≤1.5×UNL, alkaline phosphatase (ALP) ≤1.5×UNL;
- Total bilirubin (TBIL) ≤1.5×UNL;
- No severe abnormalities on electrocardiogram, left ventricular ejection fraction (LVEF) ≥50%;
- Absence of other severe medical conditions or comorbidities that would preclude tolerance to the clinical trial intervention.
- Signed informed consent, indicating understanding of the trial's purpose, risks, and potential benefits.
Who cannot join
- History of other malignancies.
- Breast and chest wall recurrence, brain metastases, multiple bone metastases with fracture risk, or visceral metastases outside the liver.
- Tumor volume ≥70% of liver volume.
- History of heart failure (NYHA class >I), myocardial infarction, unstable angina, stroke, or poorly controlled arrhythmia.
- Active infection, severe allergic reactions, or autoimmune diseases, including but not limited to:
- Active tuberculosis (TB), currently receiving or having received anti-TB treatment within the past year;
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- HIV infection (HIV1/2 antibody positive);
- Active hepatitis B or hepatitis C virus infection;
- History of systemic lupus erythematosus, rheumatoid arthritis, chronic lymphocytic thyroiditis, hyperthyroidism, polyarteritis nodosa, autoimmune hemolytic anemia, etc.
- Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period.
- Uncontrolled hypertension, diabetes, or other serious diseases.
- Severe uncontrolled dysfunction of the liver, kidneys, lungs, or other vital organs.
- Pregnant or lactating patients.
- History of mental illness.
- Known allergy to albumin-bound paclitaxel, nedaplatin, or related drugs.
- Current participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Xiaolin Li, +86-571-88122222, 847678911@qq.com
About this study
Study Objective: To Evaluate the Efficacy of Albumin-Bound Paclitaxel Combined with Nedaplatin via Hepatic Arterial Infusion as Later-Line Therapy for Breast Cancer Patients with Liver Metastases After Failure of Standard Treatment.
Outcome Measures：Primary Outcome: Liver Progression-Free Survival (LPFS) Secondary Outcomes:Liver Objective Response Rate (LORR)、Progression-Free Survival (PFS) and Overall Survival (OS)
Read more
Participants will:
- Albumin-bound paclitaxel + nedaplatin (TP) regimen is administered via hepatic arterial infusion chemotherapy on Day 1 of each cycle.
- Tumor response will be assessed every 6 weeks (±7 days) according to RECIST 1.1 criteria until disease progression is determined by the investigator.
- Being tested
- Abraxane, Nedaplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
Abraxane，200 mg，Via hepatic arterial catheter infusion，Every three weeks
NedaplatinDrug
Nedaplatin，100 mg，Via hepatic arterial catheter infusion，Every three weeks
| Study group | Role | What they receive |
|---|---|---|
| Abraxane+Nedaplatin | Experimental | 1. Abraxane：Dosage: 200 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes
2. Nedaplatin：Dosage: 100 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes，Treatment Cycle: Each cycle spans 3 weeks, for a total of 6-8 cycles. The exact number of cycles may be adjusted based on the patient's tolerance and disease response. Receives: Drug: Abraxane; Drug: Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver progression-free survival, L-PFS
The period from the first liver artery chemotherapy infusion to the time of the first recorded liver tumor progression or the patient's death
Measured: Up to approximately 33 months
Secondary outcomes (3)
Liver objective response rate, L-ORR
The proportion of patients in the treatment group who achieved complete response (CR) or partial response (PR) for liver masses.
Measured: Up to approximately 33 months
progression-free survival, PFS
From the time of the first hepatic artery chemotherapy infusion to the time of the first recorded local tumor progression or the patient's death
Measured: Up to approximately 33 months
overall survival, OS
overall survival, OS
Measured: The time from date of enrollment to the date of death due to any cause up to approximately 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Feb 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Artery InfusionStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Model description
- Intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Hai, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284836
- Sponsor's protocol ID
- IIT-2024-467
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Albumin-Bound Paclitaxel Combined With Nedaplatin (TP) Via Hepatic Arterial Infusion for Advanced Breast Cancer Patients With Liver Metastases After Failure of Standard Therapy
- ClinicalTrials.gov ID
- NCT07284836
- Acronym / sponsor ID
- IIT-2024-467
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 16 Dec 2025 (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.
Study Objective: To Evaluate the Efficacy of Albumin-Bound Paclitaxel Combined with Nedaplatin via Hepatic Arterial Infusion as Later-Line Therapy for Breast Cancer Patients with Liver Metastases After Failure of Standard Treatment.
Outcome Measures：Primary Outcome: Liver Progression-Free Survival (LPFS) Secondary Outcomes:Liver Objective Response Rate (LORR)、Progression-Free Survival (PFS) and Overall Survival (OS)
Participants will:
- Albumin-bound paclitaxel + nedaplatin (TP) regimen is administered via hepatic arterial infusion chemotherapy on Day 1 of each cycle.
- Tumor response will be assessed every 6 weeks (±7 days) according to RECIST 1.1 criteria until disease progression is determined by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention
| Arm | Type | Receives |
|---|---|---|
| Abraxane+Nedaplatin | Experimental | Drug: Abraxane, Drug: Nedaplatin1. Abraxane：Dosage: 200 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes 2. Nedaplatin：Dosage: 100 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes，Treatment Cycle: Each cycle spans 3 weeks, for a total of 6-8 cycles. The exact number of cycles may be adjusted based on the patient's tolerance and disease response. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with liver metastases from breast cancer pathologically confirmed via surgery or biopsy.
- ⑦ Adequate organ function.
Key exclusion criteria (16 listed)
- History of other malignancies.
- Breast and chest wall recurrence, brain metastases, multiple bone metastases with fracture risk, or visceral metastases outside the liver.
- Tumor volume ≥70% of liver volume.
- History of heart failure (NYHA class >I), myocardial infarction, unstable angina, stroke, or poorly controlled arrhythmia.
- Active infection, severe allergic reactions, or autoimmune diseases, including but not limited to:
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 |
|---|---|---|
| AbraxaneAbraxane，200 mg，Via hepatic arterial catheter infusion，Every three weeks | Drug | Abraxane+Nedaplatin |
| NedaplatinNedaplatin，100 mg，Via hepatic arterial catheter infusion，Every three weeks | Drug | Abraxane+Nedaplatin |
Primary outcome
Liver progression-free survival, L-PFS
Time frame: Up to approximately 33 months
The period from the first liver artery chemotherapy infusion to the time of the first recorded liver tumor progression or the patient's death
3 secondary outcomes
Liver objective response rate, L-ORR
Time frame: Up to approximately 33 months
progression-free survival, PFS
Time frame: Up to approximately 33 months
overall survival, OS
Time frame: The time from date of enrollment to the date of death due to any cause up to approximately 33 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abraxane and Nedaplatin in people with Hepatic Artery Infusion and Liver Metastasis of Breast Cancer, run by Zhejiang Cancer Hospital at 1 site 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 17 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xaolin Li (8615024437258 ext. 86057188122222, 847678911@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver progression-free survival, L-PFS (time frame: Up to approximately 33 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 16 Dec 2025.