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

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.

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Key information

Conditions

Esophageal Cancer CtDNA Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinhua Municipal Central Hospital, Jinhua, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Induction Immunochemotherapy

Diagnostic Test

Induction Immunochemotherapy:Toripalimab 240 mg (immunotherapy) combined with paclitaxel (135 mg/m²) and cisplatin (75 mg/m²) chemotherapy, administered every 3 weeks for 2 cycles. Other Names: - Radiotherapy: 95% PTV 50-50.4 Gy/25-28 fractions, 1.8-2 Gy/fraction; 5 days per week. - Chemotherapy: Weekly paclitaxel (50 mg/m²) combined with cisplatin (25 mg/m²) for 5 cycles. ctDNA Analysis:Initial tissue and blood ctDNA testing prior to treatment (T0) is based on next-generation sequencing (NGS) technology, utilizing tumor-informed assays. Blood ctDNA samples will be collected before chemoradiotherapy, after 20 fractions of radiotherapy, and every 3 months following completion of chemoradiotherapy.

Primary outcomes

Progression-free survival (PFS)

Time frame: one year

We aim to evaluate the progression-free survival (PFS) of patients with unresectable esophageal squamous cell carcinoma who accept concurrent chemoradiotherapy and received sequential treatment with Triptolide injection after radiotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Shubo Ding, MD

CONTACT

[email protected]

+8613750983285

Zhifeng Tian, MD

CONTACT

[email protected]

+8613515789419

Sponsors and collaborators

Lead sponsor

The Central Hospital of Lishui City

Other

Collaborators

Affiliated Hospital of Jiaxing University
Jinhua Central Hospital
People's Hospital of Quzhou

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Jan 27, 2025
Registry last updated: Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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