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Safety and efficacy of liposomal doxorubicin combined with nab-paclitaxel in the treatment of locally advanced or recurrent/metastatic adenoid cystic carcinoma of head and neck: a prospective, multicenter phase II trial

Safety and efficacy of liposomal doxorubicin combined with nab-paclitaxel in the treatment of locally advanced or recurrent/metastatic adenoid cystic carcinoma of head and neck: a prospective, multicenter phase II trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044076
Enrollment
Unknown
Registered
2021-03-09
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

adenoid cystic carcinoma of head and neck

Interventions

experimental group:liposomal doxorubicin plus nab-paclitaxel

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged >= 18 and = 1.5 x 10^9 /L, platelet count >= 100 x 10^9 /L, Hb >= 90 g / L, WBC >= 3.0 x 10^9 / L, and no bleeding tendency; 7.Liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) are = 50% by echocardiography; 10.Understand the circumstances of this study, patients and/or legal representatives voluntarily agree to participate in the trial and sign informed consent book.

Exclusion criteria

Exclusion criteria: 1.The investigator believes that it will affect the subject's uncontrolled serious medical disease treated with the study protocol, such as a combination of serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Uncontrolled infection, active peptic ulcer, etc.; 2.Dementia, mental state changes, or any mental illness that would prevent understanding or make informed consent or fill out a questionnaire; 3.Subjects with >= 2 peripheral neuropathy according to CTCAE V5.0; 4.History of allergies or hypersensitivity reactions to any of the therapeutic ingredients; 5.Have a history of other tumors, except for cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 6.Any abnormal bone marrow hyperplasia and other hematopoietic dysfunction; 7.Those who have received any other test drug treatment or participated in another interventional clinical trial within 30 days prior to screening; 8.Pregnant or lactating female patients; subjects of childbearing age who refuse to receive contraceptives; 9.The investigator believes that it is not suitable for the group.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
disease control rate;Progression-Free-Survival;overall survival;safety;

Countries

China

Contacts

Public ContactXinxin Zhang

Chinese PLA General Hospital

xinxinzhang66@hotmail.com+86 15910520109

Outcome results

None listed

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