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The role of hypofractionated radiotherapy combined with PD-1 inhibitors in the treatment of head and neck mucosal melanoma

The role of hypofractionated radiotherapy combined with PD-1 inhibitors in the treatment of head and neck mucosal melanoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019573
Enrollment
Unknown
Registered
2018-11-18
Start date
2018-11-13
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

mucosal melanoma of head and neck

Interventions

Case series:hypofractionated radiotherapy+PD-1 inhibitors

Sponsors

Beijing Tongren Hospital, Capital Medicine University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 100 patients with head and neck malignant melanoma confirmed by pathology were classified into stage III and stage IV according to the classification of malignant melanoma in head and neck mucosa of AJCC 8th edition. According to the pathology and genetics of head and neck tumors, the diagnostic criteria for melanoma are WHO; 2. aged 18-70 years old; 3. Stage IV includes IVA, IVB and IVC patients; 4. KPS score is above 80 points; 5. the main organs of hemogram, heart, lung, liver and kidney are basically normal. WBC (> 3.5 X 10^9/L), ANC (> 1.5 X 10^9/L), PLT (> 100 X 109/L), Hb (> 80 g/L), plasma total bilirubin (< 1.5 X), ALT, AST or AKP (< 2.5 X), urea nitrogen and muscle intoxication (< 1.25 X); 6. CT, MRI and whole body PET-CT, lymph node examination and endoscopy should be improved before admission; 7. signing informed consent, good compliance.

Exclusion criteria

Exclusion criteria: 1. there is an unexpected seizure, central nervous system disorder or loss of insight due to mental illness; 2. serious and non controllable infection; 3. main organs dysfunction (including heart, lung, liver, kidney, etc.); 4. there will be other malignancies within two years.

Design outcomes

Primary

MeasureTime frame
OS;Local recurrence rate ;Metastasisi rate;Local remission rate ;

Countries

China

Contacts

Public ContactXiaohong Chen

Beijing Tongren Hospital, Capital Medicine University

trchxh@163.com+86 13911071002

Outcome results

None listed

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