CClinicalTrials.gg
RecruitingNCT05940441Updated Jul 11, 2023

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

An observational study in to Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal Carcinoma, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-11.

Sponsored by Eye & ENT Hospital of Fudan University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • to Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal Carcinoma

Browse trials for

03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 74 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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 )

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 ).

      1. No clinical evidence of persistent locoregional disease or distant metastases after definitive chemoradiotherapy.
      1. 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).
      1. Patients must be appraised of the investigational nature of the study and provide written informed consent.

Exclusion criteria

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.

    1. 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).
    1. With esophagus cancer. 5. Pregnancy or lactation. 6. Other conditions that are not eligible for enrollment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • DrugCapecitabine 500Mg Oral Tablet

    650 mg/m² body surface area twice daily for 1 year

06

What researchers measure

Primary outcomes

  1. disease-free survival

    the time from enrolled to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause

    Time frame: 2023.7-2025.7

07

Study locations

1 of 1 sites recruiting
  • Eye & ENT Hospital, Fudan University
    Shanghai, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — the overall surviving results will be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05940441
Lead sponsor
Eye & ENT Hospital of Fudan University
Responsible party
Sponsor
First posted
Jul 11, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Jul 11, 2023

Study contacts

Lei Tao
Contact
doctortaolei@163.com
+86-13916944810

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion