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
This trial does not accept healthy volunteersQualifiers
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 population
Oligometastatic ESCC
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Two arms adopt local intervention administered at distinct timings.
Other interventionBoth study arms receive chemoimmunotherapy combined with local intervention modalities, which encompass radiotherapy, surgery and ablation. In the early local therapy arm, local intervention is initiated within 2 cycles of chemoimmunotherapy, whereas patients in the delayed local therapy arm start local intervention after completing 4 cycles of chemoimmunotherapy.
Treatment groups
354 Participants
are divided into 2 treatment groupsGroup A: Early Local Therapy Arm1 intervention
Group B: Delayed Local Therapy Arm1 intervention
Trial outcomes
Primary outcomes
1
progression free survival (PFS）
PFS is defined as the time interval between the date of the first treatment and the date of first confirmed disease progression or death from any cause. If the patient does not have tumor progression or death at the time of data analysis, the time of the last tumor evaluation will be used as the endpoint for PFS.
Time frame
3-years2
overall survival (OS)
the interval between the date of first systemic treatment and the date of death from any cause, and for patients who are still alive at the time point of the final analysis, the time of their last contact will be used as the survival time.
Time frame
3-yearsSponsors and contacts
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Source ClinicalTrials.gov