Clinical trial · Observational
Dynamic ctDNA Monitoring in Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
A Study on Dynamic Monitoring of ctDNA in Neoadjuvant Therapy With Cetuximab Combined With Albumin-bound Paclitaxel and Nedaplatin for Esophageal Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, multicenter, open-label, observational cohort study. The primary endpoint is pathological complete response (pCR), and the secondary endpoints include R0 resection rate, ctDNA clearance rate, major pathological response (MPR), recurrence-free survival (RFS), and overall survival (OS). Chinese patients with esophageal squamous cell carcinoma who are eligible for surgical resection will receive neoadjuvant therapy with cetuximab combined with albumin-bound paclitaxel and nedaplatin. Personalized ctDNA monitoring will be conducted at multiple time points, including before neoadjuvant therapy, during therapy, preoperatively, postoperatively, and during adjuvant therapy, to explore the clinical value of minimal residual disease (MRD) as a biomarker for assessing treatment efficacy, predicting recurrence risk, and evaluating prognosis in esophageal squamous cell carcinoma. This study aims to enroll 100 Chinese patients with stage II-III (potentially) resectable esophageal squamous cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- pCR
- timeFrame
- Up to 1 year
- description
- pCR stands for pathological complete response. It refers to the absence of any detectable cancer cells in the tissue sample taken during surgery after neoadjuvant treatment.
Secondary outcomes (5)
- measure
- R0 resection rate
- timeFrame
- Up to 1 year
- description
- The R0 resection rate refers to the rate of complete tumor removal without any residual tumor cells in the surgical specimen after neoadjuvant treatment.
- measure
- ctDNA clearance rate
- timeFrame
- Up to 1 year
- description
- The ctDNA clearance rate refers to the extent of elimination of circulating tumor DNA (ctDNA) during neoadjuvant treatment. It is evaluated by comparing the levels of ctDNA before and after neoadjuvant therapy to assess the impact of treatment on the tumor.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available