Dynamic ctDNA Monitoring in Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma

NCT06103890 | Unknown

• 1 other identifier: NATEC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Esophageal Squamous Cell Carcinoma

Keywords

neoadjuvant therapy; esophageal squamous cancer; ctDNA; immunochemotherapy; dynamic monitoring; biomarker

Outcome Measures

Primary Outcomes (1)

• pCR

  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.

  Up to 1 year

Secondary Outcomes (5)

• R0 resection rate

  Up to 1 year

• ctDNA clearance rate

  Up to 1 year

• MPR

  Up to 1 year

• RFS

  3 years

• OS

  3 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage II-III (potentially) operable esophageal squamous cell carcinoma

You may qualify if:

• Age between 18 and 70 years, regardless of gender.
• Patients with histologically confirmed clinical stage II-III thoracic esophageal squamous cell carcinoma.
• Neck enhanced CT scan showing no suspicious lymph node metastasis in the neck; no systemic metastasis detected by imaging examination.
• Expected to achieve R0 resection.
• ECOG performance status of 0-1.
• No prior anti-tumor treatment for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy.
• Measurable lesions (according to RECIST v1.1 criteria).
• Preoperative evaluation of organ function shows no contraindications for surgery.
• Laboratory tests confirm good bone marrow, liver, kidney function, and coagulation function.
• Able to provide informed consent and willing to cooperate with clinical follow-up.
• 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.

You may not qualify if:

• Unable to provide a sufficient amount of tissue samples/blood samples required for the study before treatment.
• Patient refuses to undergo MRD testing.
• 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).
• 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.
• Severe cardiovascular or cerebrovascular diseases.
• History of interstitial lung disease or active pneumonia requiring steroid treatment at enrollment.
• Active tuberculosis at enrollment or received anti-tuberculosis treatment within the past year.
• Bronchial asthma requiring intermittent use of bronchodilators or other medical interventions at enrollment.
• Presence of systemic infectious diseases requiring systemic treatment within the past 4 weeks at enrollment.
• Severe unhealed wounds, active ulcers, or untreated fractures at enrollment.
• Presence of other non-surgical conditions.
• Previous surgeries that prevent the use of gastric conduit for esophageal reconstruction.
• Severe allergic reactions to chemotherapy drugs (such as paclitaxel, albumin-bound paclitaxel, cisplatin, or carboplatin) or any monoclonal antibody.
• History of organ transplantation.
• Other conditions deemed unsuitable for participation in this study according to the investigator's judgment.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead
• Handan Central Hospital: collaborator
• Xingtai People's Hospital: collaborator

Study Sites (1)

Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Ziqiang Tian, MD

  Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University

  STUDY CHAIR

Central Study Contacts

Ziqiang Tian, MD

CONTACT

18531118000; tianzq1026@163.com

Huilai Lv, MD

CONTACT

13931135605; lvhl2288@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 27, 2023
• Study Start: May 22, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

CN (1)