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To evaluate the clinical study of 6-gene-panel for predicting the sensitivity of laryngo-hypopharyngeal carcinoma to induced chemotherapy

To evaluate the clinical study of 6-gene-panel for predicting the sensitivity of laryngo-hypopharyngeal carcinoma to induced chemotherapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059675
Enrollment
Unknown
Registered
2022-05-06
Start date
2022-12-01
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

laryngo-hypopharyngeal carcinoma

Interventions

Gold Standard:Clinical outcome
Index test:6-gene-panel

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with intermediate and advanced throat cancer (local tumor T2-4, any N) who reach PR after 2-3 cycles of induction chemotherapy [refer to the eighth edition of AJCC-TNM staging]; 2. Age 18-75 years; 3. Newly treated patients (primary, without history of surgery, radiotherapy and chemotherapy); 4. KPS score 80 points and above; 5. Blood picture, heart, lung, liver, kidney and other major organs are basically normal. WBC=3.5 × 109/LANC=1.5 × 109/L PLT=100 × 109/L, Hb = 80g/L, plasma total bilirubin = 1.5 × Upper limit of normal value, ALT, AST or AKP = 2.5 × Upper limit of normal value, urea nitrogen, creatinine = 1.25 × Upper limit of normal value; 6. Complete enhanced CT and endoscopic examination of neck and chest before enrollment; 7. Pathological examination before enrollment (degree of differentiation, immunological index - Ki-67, EGFR, HPV); 8. Sign the informed consent form with good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with distant metastasis; 2. Patients who can be removed by minimally invasive surgery such as laser under the support laryngoscope; 3. Have uncontrollable seizures, central nervous system disorder or loss of insight due to mental illness; 4. Serious uncontrollable infection; 5. Those with major organ dysfunction (including heart, lung, liver, kidney, etc.); 6. Those who cannot tolerate general anesthesia; 7. Other malignant tumors at the same time or within two years.

Design outcomes

Secondary

MeasureTime frame
overall survival;

Primary

MeasureTime frame
prediction;SEN, SPE, ACC, AUC of ROC;Adverse events;

Countries

China

Contacts

Public ContactJugao Fang

Beijing Tongren Hospital, Capital Medical University

fangjugao@163.com+86 18811612211

Outcome results

None listed

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