Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Fudan University Shanghai cancer center
RECRUITING
Shanghai
Contact Information
Primary
Qi Liu, MD
18017317882@163.com
86-18017317882
Backup
Kuaile Zhao, MD
kuaile_z@sina.com
86-18017312534
Time Frame
Start Date: 2022-09-27
Estimated Completion Date: 2027-09-27
Participants
Target number of participants: 354
Treatments
Experimental: PD-1 inhibitor+/- chemotherapy combined with local therapy
Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy)
Active_comparator: PD-1 inhibitor +/- chemotherapy alone
Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy)
Related Therapeutic Areas
Sponsors
Leads: Fudan University