PD-1 Inhibitors Combined With Local Therapy at Different Timings in Oligometastatic ESCC

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University

About this trial

Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below 20%. As an effective modality for local disease control, local radiotherapy has no established optimal sequencing schedule when combined with systemic therapy. The timing of radiotherapy intervention may directly affect treatment efficacy, treatment tolerance and quality of life of patients.

Several studies have explored the impact of radiotherapy timing in oligometastatic ESCC, yet substantial limitations persist in current evidence, resulting in a lack of unified guideline recommendations and wide heterogeneity in clinical practice. Most existing investigations are retrospective or small-sample prospective studies with high heterogeneity in study design, patient population selection and treatment regimens, yielding inconsistent conclusions that cannot support consistent clinical consensus.

To clarify the impact of radiotherapy timing on clinical efficacy in oligometastatic esophageal cancer, the investigator designed the present clinical trial. This study aims to compare the efficacy and safety of concurrent radiotherapy versus sequential radiotherapy on the basis of immunochemotherapy among patients with oligometastatic ESCC, so as to fill the evidence gap in existing research.

Eligibility criteria

Qualifiers

An eastern cooperative oncology group (ECOG) score of 0-1.

Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.

Genuine oligometastasis (without a history of polyme-tastatic disease).

A total of four or fewer distant metastases, a maximum of three metastases in a single organ, and a maximum diameter of each metastatic lesion not exceeding 5 cm.

Disqualifiers

Pregnant or lactating women.

Lung V20 remains over 25%.

Confirmed diagnosis or clinical suspicion of esophageal fistula.

Recurrence in the irradiated field.

Trial design

Treatments tested in this trial

  • Two arms adopt local intervention administered at distinct timings.

Treatment groups

354 Participants
are divided into 2 treatment groups

Sponsors and collaborators