drugset / Trial / NCT06452602

Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.

NCT06452602 ↗

NaSingle-groupOpen-labelTreatment

Summary

This trial is conducted in patients with unresectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 60 patients with unresectable locally advanced esophageal cancer in Tianjin cancer hospital. After 2 cycles of induction immunochemotherapy, 60 patients with ESCC will be divided into 2 groups (CR+PR group and SD+PD group) according to the efficacy of induction therapy. Patients in the CR+PR group will be treated with the same immunochemotherapy regimen plus concurrent radiotherapy (50.4Gy/1.8Gy/28f) . And immunotherapy will maintain for a maximum of 1 year. Patients in the SD+PD group will be treated with concurrent chemoradiotherapy (Radiotherapy: PTV/PGTV:50.4Gy/59.92Gy/28f and another chemotherapy regimen). Immunotherapy will not used during chemoradiotherapy because of immunotherapy resistance. The trial can effectively stratify patients by induction immunochemotherapy, and a more appropriate treatment regimen for patients has the potential to further improve PFS and prolong OS in all patients.

Timeline

Start
2024-06-19
Primary completion
2026-06-01
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody 1200 mg Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 220 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 1600 mg/m2 Intravenous

Indications