Monitoring ctDNA in patients receiving neoadjuvant therapy for esophageal cancer

A Study on Dynamic Monitoring of ctDNA in Neoadjuvant Therapy With Cetuximab Combined With Albumin-bound Paclitaxel and Nedaplatin for Esophageal Squamous Cell Carcinoma

This study is testing if tracking a specific DNA marker in the blood can help doctors see how well neoadjuvant therapy works for patients with esophageal cancer and predict their chances of recurrence.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, cetuximab
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06103890 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to enroll 100 Chinese patients with stage II-III esophageal squamous cell carcinoma who are eligible for surgical resection. Participants will receive neoadjuvant therapy with cetuximab, albumin-bound paclitaxel, and nedaplatin, while personalized ctDNA monitoring will be conducted at multiple time points to assess treatment efficacy and predict recurrence risk. The study will collect tumor tissue samples for whole-exome sequencing and blood samples for ctDNA analysis before, during, and after therapy to evaluate minimal residual disease as a biomarker for prognosis. The primary endpoint is pathological complete response, with secondary endpoints including recurrence-free survival and overall survival.

Who should consider this trial

Good fit: Ideal candidates are Chinese patients aged 18-70 with histologically confirmed stage II-III thoracic esophageal squamous cell carcinoma.

Not a fit: Patients with prior anti-tumor treatments or those with systemic metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment monitoring and outcomes for patients with esophageal squamous cell carcinoma.

How similar studies have performed: Other studies have shown promise in using ctDNA monitoring for cancer treatment, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 70 years, regardless of gender.
2. Patients with histologically confirmed clinical stage II-III thoracic esophageal squamous cell carcinoma.
3. Neck enhanced CT scan showing no suspicious lymph node metastasis in the neck; no systemic metastasis detected by imaging examination.
4. Expected to achieve R0 resection.
5. ECOG performance status of 0-1.
6. No prior anti-tumor treatment for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy.
7. Measurable lesions (according to RECIST v1.1 criteria).
8. Preoperative evaluation of organ function shows no contraindications for surgery.
9. Laboratory tests confirm good bone marrow, liver, kidney function, and coagulation function.
10. Able to provide informed consent and willing to cooperate with clinical follow-up.
11. Willing to provide peripheral blood samples for testing, as well as the patient's medical history, current treatment information, imaging studies, and tumor marker data, and willing to use the testing data for further scientific research, clinical diagnosis and treatment, and commercial product development.

Exclusion Criteria:

1. Unable to provide a sufficient amount of tissue samples/blood samples required for the study before treatment.
2. Patient refuses to undergo MRD testing.
3. History of malignancies other than esophageal cancer within the past 5 years (excluding cured localized tumors, such as cervical carcinoma in situ, basal cell carcinoma, and prostate carcinoma in situ; patients with prostate cancer who have received hormone therapy and achieved disease-free survival for more than 5 years are not excluded).
4. History of gastrointestinal bleeding within the past 6 months, or presence of coagulation abnormalities at enrollment, or currently receiving thrombolytic or anticoagulant therapy, indicating a high risk of bleeding.
5. Severe cardiovascular or cerebrovascular diseases.
6. History of interstitial lung disease or active pneumonia requiring steroid treatment at enrollment.
7. Active tuberculosis at enrollment or received anti-tuberculosis treatment within the past year.
8. Bronchial asthma requiring intermittent use of bronchodilators or other medical interventions at enrollment.
9. Presence of systemic infectious diseases requiring systemic treatment within the past 4 weeks at enrollment.
10. Severe unhealed wounds, active ulcers, or untreated fractures at enrollment.
11. Presence of other non-surgical conditions.
12. Previous surgeries that prevent the use of gastric conduit for esophageal reconstruction.
13. Severe allergic reactions to chemotherapy drugs (such as paclitaxel, albumin-bound paclitaxel, cisplatin, or carboplatin) or any monoclonal antibody.
14. History of organ transplantation.
15. Other conditions deemed unsuitable for participation in this study according to the investigator's judgment.

Where this trial is running

Shijiazhuang, Hebei

• Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Study coordinator: Ziqiang Tian, MD

Conditions Esophageal Squamous Cell Carcinoma; neoadjuvant therapy; esophageal squamous cancer; ctDNA; immunochemotherapy; dynamic monitoring; biomarker