First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center Trial (SCR-ESCC-01)

NCT05978193 Phase 2 RECRUITING

SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.

Details

Lead sponsor	Shanghai Chest Hospital
Phase	Phase 2
Status	RECRUITING
Enrolment	100
Start date	2023-01-01
Completion	2028-01-01

Conditions

• Esophageal Squamous Cell Carcinoma
• Esophageal Cancer
• Metastatic Esophageal Squamous Cell Carcinoma

Interventions

• LDRT+CFRT
• Immunotherapy
• Chemotherapy

Primary outcomes

• PFS — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
  Progression-free survival
• Safety and Feasibility of the Combined Regimen (Safety Run-in Phase) — From start of treatment up to 30 days after the last dose.
  Incidence of Treatment-Related Adverse Events (TRAEs) in the initial cohort.

Countries

China