OncoMatch/Clinical Trials/NCT05044117
Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)
Is NCT05044117 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Capecitabine for head and neck squamous cell carcinoma.
Treatment: Capecitabine — The purpose of this study is to investigate whether the addition of metronomic capecitabine to the standard treatment can improve prognosis in locoregionally advanced head and neck squamous cell carcinoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Excluded: CDKN2A p16 positive
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: surgery plus radiotherapy or concurrent chemoradiotherapy — adjuvant
Radical surgery plus radiotherapy or concurrent chemoradiotherapy
Must have received: neoadjuvant therapy plus radical radiotherapy or concurrent chemoradiotherapy — neoadjuvant/adjuvant
Neoadjuvant therapy plus radical radiotherapy or concurrent chemoradiotherapy
Must have received: concurrent chemoradiotherapy — definitive
Concurrent chemoradiotherapy
Cannot have received: surgery, chemotherapy, radiotherapy or other anti-tumor treatments to primary tumor or nodes before the standard therapy
Exception: diagnostic procedures
Prior surgery, chemotherapy, radiotherapy or other anti-tumor treatments (except diagnostic) to primary tumor or nodes before the standard therapy
Cannot have received: surgery treatment, biotherapy or immunotherapy during radiotherapy
Patients who received surgery treatment, biotherapy or immunotherapy during radiotherapy
Cannot have received: chemotherapy, biotherapy or immunotherapy after radiotherapy
Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy after radiotherapy
Lab requirements
Blood counts
neutrophil count > 1.5×10^9/l, hemoglobin > 90g/l and platelet count > 100×10^9/l
Kidney function
creatinine clearance ≥ 50 ml/min
Liver function
alanine aminotransferase, aspartate aminotransferase ≤ 1.5×uln, bilirubin ≤ 1.5×uln, alkaline phosphatase ≤ 2.5×uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05044117 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior surgery, chemotherapy, radiotherapy or other anti-tumor treatments to primary tumor or nodes before the standard therapy, surgery treatment, biotherapy or immunotherapy during radiotherapy, chemotherapy, biotherapy or immunotherapy after radiotherapy disqualifies patients from enrollment.
Are patients with CDKN2A alterations eligible?
No. CDKN2A p16 positive is an exclusion criterion.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages