Evaluating ctDNA Changes After Chemotherapy and Radiotherapy for Esophageal Cancer

A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring

This study is testing if a new treatment after chemotherapy and radiotherapy can help people with advanced esophageal cancer by looking at changes in their tumor DNA to see how well the treatment is working.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Central Hospital of Lishui City (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Jinhua, Zhejiang and 1 other locations)
• Trial ID: NCT06792786 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed esophageal squamous cell carcinoma who have not undergone prior treatment.

Not a fit: Patients with early-stage esophageal cancer or those who have previously received treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment strategy for patients with advanced esophageal cancer, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results using ctDNA as a biomarker in cancer treatment, suggesting that this approach may be effective.

Eligibility criteria

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 this trial is running

Jinhua, Zhejiang and 1 other locations

• 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

Conditions: Esophageal Cancer, ctDNA, esophageal cancer, chemoradiotherapy, induction immunochemotherapy, prognosis