Circulating Tumor Cell Counts in Postoperative ENE-Positive Oral Cavity Cancer Patients After Adjuvant CCRT

NCT07296250 | Recruiting

• 1 other identifier: 202402125B0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer; Oral Cancer

Keywords

oral cancer; ENE; Circulating tumor cells; Adjuvant concurrent Chemoradiation, adjuvant CCRT; Circulating tumor microemboli (CTM)

Outcome Measures

Primary Outcomes (4)

• Circulating tumor cells (CTCs) testing

  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.

  baseline

• Circulating tumor cells (CTCs) testing

  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.

  3 month

• Circulating tumor cells (CTCs) testing

  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.

  6 month

• Circulating tumor cells (CTCs) testing

  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.

  9 month

Study Arms (2)

control

NO INTERVENTION

participants without low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.

experimental

EXPERIMENTAL

participants with low-dose oral chemotherapy. Each patient must continue to be tracked for ENE or other postoperative risks for one year, and with blood testing every tree month.

Procedure: low-dose oral chemotherapy

Interventions

low-dose oral chemotherapy PROCEDURE

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.

experimental

Eligibility Criteria

• Age: 18 Months - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with Cancer:
• Aged between 18 and 90 years.
• Histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC).
• Completed surgical treatment and identified as having high-risk factors, followed by concurrent chemoradiotherapy.
• Willing to continue follow-up visits at the hospital after completion of treatment.

You may not qualify if:

• Presence of psychiatric disorders.
• Deemed unsuitable for participation by the attending physician.
• Unwilling to participate in the study.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, 333423, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms; Neoplastic Cells, Circulating

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• ChunTa Liao, PhD

  Division of Otolaryngology, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChunTa Liao, PhD

CONTACT

0975360141; liaoct@cgmh.org.tw

Chia-Hsun Hsieh, PhD

CONTACT

0975366137; wisdom5000@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Attending Physicians

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

TW (1)