Phase II multicenter trial: first-line immunochemotherapy with or without radiotherapy in metastatic esophageal squamous cell cancer (SCR-ESCC-01).
Future Oncol
; 19(34): 2291-2296, 2023 Nov.
Article
in En
| MEDLINE
| ID: mdl-37937444
ABSTRACT
This randomized phase II trial (NCT05978193) combines low-dose radiotherapy (LDRT) and conventionally fractionated radiotherapy (CFRT) with immunochemotherapy for metastatic esophageal squamous cell carcinoma, aiming to assess the potential enhanced effect of radiotherapy on immunotherapy. Patients are administered a PD-1 inhibitor along with paclitaxel and platinum-based chemotherapy (arm B), or combined with LDRT and CFRT (arm A). Immunotherapy is given every 3 weeks with chemotherapy for 4 cycles, followed by immunotherapy maintenance therapy for up to 24 months. In arm A, LDRT (2 Gy, 2 fractions; delivered to the primary and all metastatic tumors) precedes each immunochemotherapy cycle for 4 cycles, followed by CFRT (40-50 Gy, 20-25 fractions; delivered to the primary tumor) starting from the fifth immunotherapy cycle. The primary end point is median progression-free survival. Clinical Trial Registration NCT05978193 (clinicaltrials.gov).
Key words
Full text:
1
Database:
MEDLINE
Main subject:
Esophageal Neoplasms
/
Carcinoma, Squamous Cell
/
Esophageal Squamous Cell Carcinoma
Limits:
Humans
Language:
En
Journal:
Future Oncol
Year:
2023
Type:
Article
Affiliation country:
China