Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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%
Trial design
Treatments tested in this trial
- PD-1 inhibitor+/- chemotherapy combined with local therapy
- systemic therapy alone
Treatment groups
354 Participants
are divided into 2 treatment groupsLocations
1Fudan University Shanghai cancer center Shanghai China
Sponsors and collaborators
Fudan University
Lead sponsor
Source ClinicalTrials.gov