Evaluating ctDNA Changes After Chemotherapy and Radiotherapy for Esophageal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy of immunoconsolidation therapy following radiotherapy and chemotherapy in patients with esophageal squamous cell carcinoma. It focuses on the dynamic changes of circulating tumor DNA (ctDNA) as a biomarker to guide treatment decisions and predict tumor progression. The study will enroll patients who have not received prior treatments and have advanced-stage cancer that is not amenable to surgery. By monitoring ctDNA levels, the researchers hope to identify early signs of treatment response or disease recurrence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All subjects must sign an informed consent form before initiating any study-related procedures;
* All patients must be aged ≥18 years and ≤75 years;
* Histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma);
* Clinical stage II-IVa, assessed by a surgeon as inoperable, or patient refusal of surgery;
* No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer;
* ECOG performance status of 0-1;
* Laboratory test values within the following limits before the first dose of the investigational drug:
* Hematology: WBC ≥3.0×10⁹/L; ANC ≥1.5×10⁹/L; PLT ≥70×10⁹/L; HGB ≥9.0 g/dL;
* Liver function: AST ≤2.5×ULN; ALT ≤2.5×ULN;
* Renal function: Cr ≤1.5×ULN or CrCl ≥40 mL/min;
* Coagulation: INR ≤1.5, APTT ≤1.5×ULN;
* Other: Lipase ≤1.5×ULN, unless clinically/radiographically insignificant if lipase \>1.5×ULN.

Exclusion Criteria:

* Insufficient tissue/blood sample available before treatment as required for the study;
* Patient refusal to undergo dynamic ctDNA testing;
* The primary esophageal lesion is in close proximity to the tracheobronchial tree or major blood vessels, with an investigator-assessed high risk of perforation or major hemorrhage;
* History of malignancies other than esophageal carcinoma within the past 5 years (except for curatively treated localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or localized prostate cancer);
* History of gastrointestinal bleeding within the past 6 months, or coagulopathy at enrollment, or current thrombolytic or anticoagulant therapy indicating a high risk of bleeding;
* Severe cardiovascular or cerebrovascular diseases;
* History of interstitial lung disease or active pneumonia/tuberculosis;
* Severe allergic reactions to paclitaxel/cisplatin or any monoclonal antibody;
* Any other condition deemed inappropriate for participation in this study as judged by the investigator.

Where it's running

• Jinhua Municipal Central Hospital
  Jinhua, Zhejiang, China Recruiting
• The central Hospital of Lishui City
  Lishui, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Zhifeng Tian, MD
• Email: tzf419@hotmail.com
• Phone: +8613515789419

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.