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 type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 74 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | July 1, 2025 |
| Study ends | July 1, 2027 |
| Registry record updated | July 11, 2023 |
| Trial ID | NCT05940441 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
- Study coordinator: Lei Tao
- Email: doctortaolei@163.com
- Phone: +86-13916944810
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Neoadjuvant finotonlimab plus TP chemotherapy for SMARCB1-deficient sinonasal cancer
This study tests whether giving finotonlimab with the TP chemotherapy regimen before surgery can shrink locally advanced SMARCB1-deficient sinonasal tumors in adults.
-
Intelligent case management for microtia care from diagnosis through rehabilitation
This trial tests a mobile, intelligent case-management platform to provide continuous, personalized nursing and health guidance for people with congenital microtia undergoing ear reconstruction.
-
Becotatug Vedotin plus PD-1 inhibitor for locally recurrent nasopharyngeal carcinoma
This study tests whether adding becotatug vedotin to a PD-1 inhibitor helps people with locally recurrent nasopharyngeal cancer.
-
Customized bifocal plus defocus lenses to slow myopic shift after congenital cataract surgery
This study tests whether individually tailored bifocal plus defocus glasses can slow myopic progression in children aged 4–12 who had bilateral congenital cataract surgery.
-
Effect of Dry Eye Treatment on Corneal Astigmatism Measurements
This study tests whether short-term treatment for dry eye changes how consistently three devices measure corneal astigmatism in people preparing for cataract surgery.
-
Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma
This study tests how well patients with T4 sinonasal adenoid cystic carcinoma tolerate the standard treatment of surgery followed by postoperative radiotherapy and what their 3-year progression-free survival looks like.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.