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Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

RECRUITINGPhase 3Sponsored by Fudan University
Actively Recruiting
PhasePhase 3
SponsorFudan University
Started2022-09-27
Est. completion2025-09-27
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06190782

Summary

Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone. The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 1\. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases

Exclusion Criteria:

* 1\. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20\>25%

Conditions4

CancerEsophageal Squamous Cell CarcinomaOligometastatic DiseaseRadiotherapy

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