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

• Status: Recruiting
• Trial end date: 2027-09-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Immune Checkpoint Inhibitors

Criteria

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%