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Clinical study of Melphalan Hydrochloride for Injection combined with hepatic artery chemoembolization in the treatment of liver metastasis of breast cancer

A Prospective, Randomized, Open-Label, Parallel-Controlled Study of Melphalan Hydrochloride for Injection Combined with Transhepatic Arterial Chemoembolization in Hepatic Metastases from Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104476
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-06-25
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Liver Metastasis

Interventions

Control group:Transhepatic arterial chemoembolization. Dobilococin hydrochloride injection 20mg/m^2, configured with 5% glucose injection.
Research group:Injectable melphalan hydrochloride combined with transhepatic arterial chemoembolization. Dobilococin hydrochloride injection 20mg/m^2, configured with 5% glucose injection. Melphalan h

Sponsors

Nanchang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Female patients aged 18-70 years; 2.Patients with a previous pathological diagnosis of breast cancer are diagnosed with luminal breast cancer and have liver metastases. 3.Pathologically confirmed HER2-negative breast cancer; 4.Child-Pugh class A of liver function or better class B (= 70 points and a performance status score of 3 months; 8.Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Triple-negative breast cancer; 2.The existence of severe liver and kidney dysfunction; 3.There are obvious contraindications to interventional therapy: obvious arteriovenous fistula; uncorrectable coagulation dysfunction and obvious blood abnormalities, with obvious bleeding tendency; persistent large amount of ascites; 4.Combined active infection, especially inflammation of bile duct system; 5.Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test or female patients of childbearing potential who are unwilling to use effective contraception throughout the trial period; 6.In the judgment of the investigator, a serious concomitant disease that jeopardizes the patient's safety, or interferes with the patient's ability to complete the study (including, but not limited to, severe hypertension that cannot be controlled by medication, severe diabetes, etc. 7.Any other condition that, in the judgment of the investigator, makes the patient unsuitable for participation in this study; 8.Patients with allergies or relevant contraindications to the components of the experimental drug or any excipients.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Overall Survival;Progression-free survival;Disease control rate;

Countries

China

Contacts

Public ContactLiu Shengshan, Wang Hong

Nanchang People's Hospital

569267018@qq.com+86 13077933598

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026