Status:
RECRUITING
Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
Lead Sponsor:
Fudan University
Conditions:
Esophageal Squamous Cell Carcinoma
Oligometastatic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 +/- chemothera...
Detailed Description
Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radi...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
September 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 27 2027
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT06190782
Start Date
September 27 2022
End Date
September 27 2027
Last Update
May 2 2024
Active Locations (1)
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1
Fudan University Shanghai cancer center
Shanghai, China