Multimodal Al for Precision Diagnosis of Esophageal Cancer

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: The study population will consist of adult patients (≥18 years) with pathologically confirmed esophageal squamous cell carcinoma (ESCC) who underwent diagnostic endoscopy and contrast-enhanced CT examination at participating centers. Patients with early-stage disease who received endoscopic resection or esophagectomy and had pathological assessment of tumor invasion depth will be included for development and validation of a multimodal deep learning model for diagnosis and prediction of invasion depth. Patients with locally advanced disease who received neoadjuvant therapy followed by surgical resection, with available pathological response and follow-up data, will be included for development and validation of a multimodal model for predicting treatment response and prognosis. Clinical information, CT images, endoscopic images, pathological findings, and survival outcomes will be collected for analysis.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Esophageal Cancer

Being tested

NAT, ESD, surgery

Medical subject headings

Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• NATOther

  Neoadjuvant therapy has become a standard treatment strategy for patients with locally advanced esophageal squamous cell carcinoma (ESCC). Administered before surgical resection, neoadjuvant treatment aims to reduce tumor burden, downstage disease, increase the likelihood of complete (R0) resection, and improve long-term survival outcomes. Current neoadjuvant approaches include chemotherapy, chemoradiotherapy, and more recently, immune checkpoint inhibitor-based combination therapies. Among these, neoadjuvant immunochemotherapy has demonstrated promising pathological response rates and survival benefits, emerging as an important treatment option for ESCC. However, treatment response varies considerably among patients, highlighting the need for reliable predictive models to guide individualized therapeutic decision-making.

• ESDOther

  Endoscopic submucosal dissection (ESD) is a minimally invasive endoscopic technique used for en bloc resection of superficial gastrointestinal neoplasms. The procedure is performed under conscious sedation or general anesthesia using a therapeutic endoscope. After lesion characterization and marking of the resection margins, a submucosal injection solution (e.g., saline mixed with epinephrine, dye, or viscous agents such as hyaluronic acid) is administered to lift the lesion from the muscularis propria. A circumferential mucosal incision is then made using an endoscopic knife, followed by meticulous submucosal dissection to separate the lesion from the underlying muscle layer. Hemostasis is achieved throughout the procedure using coagulation forceps or hemostatic devices as needed. The lesion is removed en bloc whenever possible, and the resected specimen is retrieved for histopathological evaluation. Post-resection inspection of the artificial ulcer is performed to assess for bleeding

• surgeryOther

  Additional surgery refers to esophagectomy with regional lymph node dissection performed after non-curative endoscopic resection. The procedure is recommended for patients with pathological risk factors for lymph node metastasis, including deep submucosal invasion, lymphovascular invasion, positive vertical resection margins, or other non-curative resection criteria. Surgical treatment is performed according to institutional standards and current clinical guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Actual receipt of additional surgery

   Actual receipt of additional surgery was defined as patients who underwent subsequent radical surgical treatment after ESD based on multidisciplinary team (MDT) recommendations, clinician judgment, and patient preference.

   Measured: 1 week

2. Presence of pathological indications for additional surgery

   According to current guidelines, non-curative resection requiring consideration of additional radical treatment was defined by the presence of submucosal invasion (SM2 invasion), or lymphovascular invasion (LVI-positive), or a positive vertical resection margin (VM-positive).

   Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted5 Jun 2026
2. Study start1 Mar 2023
3. Primary completion1 Jan 2026
4. Study completion7 Jun 2026

Why it stopped: local ethics review

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Esophageal CancerStudies of the same condition, open and under way.
• More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.