Monitoring circulating tumor cells in postoperative ENE-positive oral cavity cancer after adjuvant concurrent chemoradiation.
Official title: A Randomized, Prospective Phase II Clinical Trial - Extended Chemotherapy or Not Based on Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Completing Adjuvant Concurrent Chemoradiotherapy
Run by Chang Gung Memorial Hospital · NCT07296250 · Data updated 2026-11-12
This trial will test whether regular blood monitoring of circulating tumor cells and adding extended low-dose oral chemotherapy can help people with ENE-positive oral cavity squamous cell carcinoma after surgery and adjuvant concurrent chemoradiation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Months to 90 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taoyuan City) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2028 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT07296250 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18–90 with histologically confirmed head and neck squamous cell carcinoma of the oral cavity who have completed surgery, have high-risk features such as ENE, and have finished adjuvant concurrent chemoradiation and are willing to return for regular follow-up.
✕Probably not a fit
Patients who do not have ENE or other postoperative high-risk features, who are medically or psychiatrically unsuitable, or who are unwilling to comply with follow-up visits and blood draws are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The protocol has two aims: first to define a circulating tumor cell (CTC)-based minimal residual disease (MRD) marker for oral cavity squamous cell carcinoma, and second to run a prospective treatment arm using extended low-dose oral chemotherapy. The study plans to enroll about 100 postoperative patients with extracapsular nodal extension (ENE) or other high-risk features and follow them for one year, drawing 10 mL of research blood at baseline and every three months for CTC analysis. CTCs will be isolated using a negative-selection system and counted by EpCAM and Hoechst staining under microscopy to identify single CTCs and circulating tumor microemboli. The investigators will correlate longitudinal CTC counts with clinical recurrence and survival to determine whether CTC-MRD can guide extended adjuvant therapy.
Why it matters
Potential benefit: If successful, this approach could provide a standard blood-based MRD test and an extended low-dose oral chemotherapy option that may improve survival for ENE-positive oral cavity cancer patients.
How similar studies have gone: Prior studies have shown that CTC presence can predict poorer prognosis in head and neck cancers, but longitudinal CTC-guided MRD and extended adjuvant low-dose chemotherapy in ENE-positive oral cavity cancer remains largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants with Cancer: 1. Aged between 18 and 90 years. 2. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC). 3. Completed surgical treatment and identified as having high-risk factors, followed by concurrent chemoradiotherapy. 4. Willing to continue follow-up visits at the hospital after completion of treatment. Exclusion Criteria: 1. Presence of psychiatric disorders. 2. Deemed unsuitable for participation by the attending physician. 3. Unwilling to participate in the study.
Where it's running
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Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan Recruiting
Study contacts
- Principal investigator: ChunTa Liao, PhD — Division of Otolaryngology, Chang Gung Memorial Hospital
- Study coordinator: ChunTa Liao, PhD
- Email: liaoct@cgmh.org.tw
- Phone: 0975360141
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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.