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A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy

A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy - A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007559
Enrollment
80
Registered
2012-03-23
Start date
2009-09-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Oropharyngeal and Hypopharyngeal squamous cell carcinoma

Interventions

Sub-mucosal administrations of alpha-GalactosylCeramide pulsed DCs are performed on day 7 and 10 after the entry. Sub-mucosal administrations of non pulsed DCs are performed on day 7 and 10 after the

Sponsors

Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with stage IV oropharyngeal and hypopharyngeal squamous cell carcinoma, who have achieved Complete Response after the standard treatment; Patients within 8 weeks after receiving the determination of Complete Response; Performance status 0-2; Normal bone marrow, liver and renal functions.

Exclusion criteria

Exclusion criteria: Patients who have: uncontrolled diabetes mellitus, pulmonary fibrosis, and/or infection; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; serious cardiac disease; recieived concurrent corticosteroid therapy; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to participate in this study by principle investigator or co-investigator

Design outcomes

Primary

MeasureTime frame
Relapse-free survival

Secondary

MeasureTime frame
Two-year relapse rate Overall survival rate Specific immune responses of peripheral blood Frequency and seriousness of adverse events

Countries

Japan

Contacts

Public ContactDaiju Sakurai

Graduate School of Medicine, Chiba University epartment of Otorhinolaryngology, Head and Neck Surgery

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026