Clinical trial Recruiting at 1 site Observational Ages 18 to 65

Exploring Metronomic Capecitabine for Advanced Hypopharyngeal Cancer

Official title: A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma

Run by Eye & ENT Hospital of Fudan University · NCT05940441 · Data updated 2026-11-12

This study is testing if a new way of giving capecitabine can help people with advanced hypopharyngeal cancer stay cancer-free after their initial treatments.

Quick facts

Study typeObservational
Ages18 Years to 65 Years
SexAll
Enrollment74 (estimated)
SponsorEye & ENT Hospital of Fudan University
Academic / other
Drugs / interventionsradiation
Locations1 site (Shanghai)
StatusRecruiting
StartedJuly 1, 2023
Main results expectedJuly 1, 2025
Study endsJuly 1, 2027
Registry record updatedJuly 11, 2023
Trial IDNCT05940441 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 65 with histologically confirmed stage IV hypopharyngeal carcinoma who have completed standard treatment and show no evidence of disease.

Probably not a fit

Patients with persistent locoregional disease or distant metastases, or those outside the specified age range, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the effectiveness of metronomic capecitabine as an adjuvant therapy in improving disease-free survival for patients with locoregionally advanced hypopharyngeal carcinoma. Participants will have completed standard treatments such as chemoradiotherapy or surgery and will be evaluated for their eligibility based on specific clinical criteria. The treatment involves administering capecitabine in a metronomic dosing schedule to assess its impact on patient outcomes.

Why it matters

Potential benefit: If successful, this approach could enhance disease-free survival rates for patients with advanced hypopharyngeal carcinoma.

How similar studies have gone: While the specific approach of metronomic capecitabine in this context is exploratory, similar studies have shown promise in using metronomic therapies for various cancers.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Eye & ENT Hospital, Fudan University
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.