NCT06792786Recruiting
A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
Esophageal squamous cell carcinoma (ESCC) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages. Concurrent chemoradiotherapy (CCRT) is the standard treatment for unresectable locally advanced ESCC. The 5-year survival rate for advanced esophageal cancer remains below 20%. Immunotherapy has demonstrated definitive efficacy and a favorable toxicity profile in advanced ESCC, and preliminary results of its combination with radiotherapy have been reported. Induction immunochemotherapy followed by concurrent chemoradiotherapy represents a feasible combined treatment strategy. However, optimal biomarkers to identify patients who would benefit from this approach are still lacking. Circulating tumor DNA (ctDNA) status can accurately guide treatment implementation and predict tumor progression. Studies have shown that ctDNA changes precede imaging evidence of recurrence or metastasis, and ctDNA detection can sensitively predict tumor progression and prognosis. Therefore, it is necessary to dynamically monitor ctDNA changes throughout the course of induction immunochemotherapy followed by radical concurrent chemoradiotherapy in esophageal cancer and explore its correlation with prognosis.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Jan 2025
- Start date
- 10 Dec 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- The Central Hospital of Lishui City
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06792786
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 10 Dec 2024 to the primary completion date, 31 May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Insufficient tissue/blood sample available before treatment as required for the study;
- Patient refusal to undergo dynamic ctDNA testing;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jinhua Municipal Central Hospital Coordinator of this site? Confirm its status | Jinhua | China | Recruiting |
| The central Hospital of Lishui City Coordinator of this site? Confirm its status | Lishui | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.