Skip to content

Identification of biomarkers which reflects the treatments effects of Nivolmab through comprehensive analyses of serum exosmal mRNA derived from the HNSCC patients.

Identification of biomarkers which reflects the treatments effects of Nivolmab through comprehensive analyses of serum exosmal mRNA derived from the HNSCC patients. - Identification of biomarkers which reflects the treatments effects of Nivolmab through comprehensive analyses of serum exosmal mRNA derived from the HNSCC patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000037029
Enrollment
150
Registered
2019-06-17
Start date
2019-07-02
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

head and neck squamous cell cancer

Interventions

None listed

Sponsors

Clinical Research Support Center Kyushu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients who are eligible for nivolumab for head and neck cancer cases with recurrence or distant metastasis. Primary site: nasal sinus, oral cavity, nasopharynx, oropharynx (p16 positive), oropharynx (p16 negative), hypopharynx, larynx (upper glottic, lower glottic) 2.Patients who are diagnosed histologically as squamous cell carcinoma. 3.Patients aged 20 and over at the time of signing the Informed Consent Form. 4.Patients with target lesion by RECIST on imaging examination within 28 days before enrollment. As basics,it is a contrast CT examination. However, if contrast-enhanced CT examination is impossible or inappropriate due to contrast agent allergy, renal dysfunction, or problems in image evaluation, simple CT, contrast-enhanced MRI, or simple MRI can be substituted. 5.Patients who fully understand this research plan and have obtained written consent.

Exclusion criteria

Exclusion criteria: 1.Patients who have been given immune checkpoint inhibitors in the past. 2.Patients with ECOG Performance Status 3 or 4 3.Patients under tumor immunotherapy or with plan to be co-administered with other antineoplastic agents. 4.Patients with active double cancer excluding CIS and endoscopically treatable early esophagus cancer. 5.patients judged inappropriate by investigators.

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
1-year survival rate

Countries

Japan

Contacts

Public ContactSatoshi Toh

National Hospital Organization Kyushu Cancer Center Department of Head and Neck Surgery

toh.satoshi.th@mail.hosp.go.jp092-541-3231

Outcome results

None listed

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