low-dose oral chemotherapy: recruit 100 oral cavity cancer patients with ENE or other postoperative risks.10 mL of research blood was drawn four times in total.Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.
Study summary
The aim 1 of this trial is the development of the Circulating tumor cells (CTCs) definition of oral cancer minimal residual disease (MRD), and aim 2 is a prospective trial of oral cancer treatment. If this trial is successful, it is expected that it may be able to provide a standard diagnostic tool (MRD in Oral Cavity Squamous Cell Carcinoma (OCSCC)) and treatment mode (extended adjuvant chemotherapy with low-dose oral chemotherapy). The survival rate of patients will be improved.
Eligibility
Sex
ALL
Min age
18 Months
Max age
90 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Circulating tumor cells (CTCs) testing — baseline participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.
Circulating tumor cells (CTCs) testing — 3 month participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.
Circulating tumor cells (CTCs) testing — 6 month participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.
Circulating tumor cells (CTCs) testing — 9 month participants will undergo CTCs testing after completing concurrent Chemoradiotherapy (CCRT). If CTC-positive (≥5.0 cells/mL), participants will receive low-dose oral chemotherapy for three months, followed by repeat CTC testing. Persistent positivity will warrant continued treatment up to one year after curative surgery, while negativity will lead to treatment discontinuation.
Trial sites (1)
Facility
City
Region
Status
Linkou Chang Gung Memorial Hospital
Taoyuan City
Taiwan
Recruiting
More Chang Gung Memorial Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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