Tracking multigene methylation changes to monitor treatment response in esophageal cancer
Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
This project will test whether changes in blood multigene methylation levels before and after initial treatment can show how well people with esophageal cancer are responding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (Wuwei, Gansu and 8 other locations) |
| Trial ID | NCT06979869 on ClinicalTrials.gov |
What this trial studies
This observational, multicenter study measures circulating multigene methylation levels before and after initial therapy in adults with non-metastatic esophageal cancer and compares those changes to objective response on contrast-enhanced CT/MRI and serum tumor markers. The primary analysis correlates pretreatment-to-posttreatment methylation shifts with objective response rate (ORR). Secondary analyses examine whether methylation fluctuation patterns relate to progression-free survival, compare diagnostic accuracy against conventional biomarkers, and explore using methylation thresholds to guide adaptive therapy changes. Participants are treatment-naive adults with histologically confirmed esophageal carcinoma enrolled at participating Chinese hospitals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 with histologically confirmed, non-metastatic esophageal carcinoma who have not received surgery, systemic chemotherapy, significant thoracic radiation, or PD-1/PD-L1 inhibitors and have complete medical records.
Not a fit: Patients with distant metastases, prior esophageal cancer treatments, life expectancy under six months, or who are legally incapacitated are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive blood test to detect treatment response earlier than imaging and help clinicians adjust therapy sooner.
How similar studies have performed: Multigene methylation blood assays have shown promising signals in several solid tumors, but their use specifically for esophageal cancer treatment surveillance is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age at initial diagnosis: 18-75 years (inclusive) Confirmed diagnosis: Histologically proven esophageal carcinoma with complete medical records, including (a) definitive pathological diagnosis report, (b) TNM staging per AJCC 8th edition criteria Cancer history: No prior malignancies at other anatomical sites (excluding cured non-melanoma skin cancers/carcinoma in situ) Metastasis status: Radiologically confirmed absence of distant metastases in liver, lungs, or other organs via contrast-enhanced CT/MRI and whole-body bone scan within 4 weeks before enrollment Treatment-naïve status: No previous exposure to (i) esophageal resection surgery, (ii) systemic chemotherapy, (iii) thoracic radiation therapy (\>10 Gy), or (iv) PD-1/PD-L1 immune checkpoint inhibitors Exclusion Criteria: Life expectancy \<6 months (as assessed by ECOG score ≥4 or Palliative Performance Scale ≤30%) Cognitive/psychiatric conditions: a. Legally incapacitated individuals without legal guardians, b. Active psychotic disorders (e.g., schizophrenia, bipolar disorder) or dementia (MMSE score \<24) Investigator-determined exclusions
Where this trial is running
Wuwei, Gansu and 8 other locations
- Gansu Wuwei Cancer Hospital — Wuwei, Gansu, China (Recruiting)
- Cancer Hospital Affiliated to Shantou University Medical College — Shantou, Guangdong, China (Not_yet_recruiting)
- Zhaoqing Gaoyao District People's Hospital — Zhaoqing, Guangdong, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
- Tangdu Hospital — Xi'an, Shaanxi, China (Not_yet_recruiting)
- Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
- The First Affiliated Hospital of Yan'an University — Yan’an, Shaanxi, China (Not_yet_recruiting)
- The First Affiliated Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Not_yet_recruiting)
- General Hospital of Western Theater Command, People's Liberation Army (PLA) — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Zhongyang Zhang
- Email: 18831363219@163.com
- Phone: +86 188 3136 3219
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.