Clinical trial · Observational
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma
NCT05940441CI-TRIAL-00067903recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore whether the adjuvant therapy of metronomic capecitabine could improve the disease-free survival of locoregionally advanced hypopharyngeal carcinoma (stage IV:T4N0-1M0,anyTN2-3M0).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| to Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine 500Mg Oral Tablet | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
- 2023.7-2025.7
- description
- the time from enrolled to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age between 18 and 65 years old. 2. Histologically confirmed hypopharyngeal carcinoma, staged as IV (T4N0-1M0,anyTN2-3M0) (as defined by the 8th AJCC edition), Complete the recommended standard treatment (curative chemoradiotherapy, or radical surgery + postoperative chemo/radiotherapy ). 3\. No clinical evidence of persistent locoregional disease or distant metastases after definitive chemoradiotherapy. 4\. Within 8 weeks after completion of the last radiation dose. 5. Performance status of ECOG grade 0 or 1. 6. Adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9 /L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \< 2.5×ULN) and renal function (creatinine clearance \> 50 ml/min). 7\. Patients must be appraised of the investigational nature of the study and provide written informed consent. Exclusion Criteria: * 1.Patients who were known to be intolerable or allergic to capecitabine. 2. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 3\. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control). 4\. With esophagus cancer. 5. Pregnancy or lactation. 6. Other conditions that are not eligible for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.