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RECRUITING
NCT06452602
PHASE2

Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Official title: Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Stratified Exploratory Phase 2 Trial.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-06-19

Completion Date

2027-06-01

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapy

Induction immunochemotherapy: Nab-paclitaxel:220mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Adebrelimab:1200mg, IV,d1, d22. Evaluation of the Curative Effect:CR+PR Adebrelimab plus concurrent chemoradiotherapy: Adebrelimab:1200mg, IV,q3w, until PD; Nab-paclitaxel:175mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Radiotherapy:50.4Gy/1.8Gy/28f.

DRUG

Induction immunochemotherapy followed by concurrent chemoradiotherapy

Induction immunochemotherapy: Nab-paclitaxel:220mg/m2,IV,d1,d22; Carboplatin:AUC=5,IV,d1,d22; Adebrelimab:1200mg, IV,d1, d22. Evaluation of the Curative Effect:SD+PD Concurrent chemoradiotherapy: Oxaliplatin:85 mg/m2,IV,d1,d15,d29; Leucovorin:400mg/m2,IV,d1,d15,d29; 5-FU:400mg/m2,IV,d1,d15,d29; 5-FU:1600mg/m2,CIV48h,d1,d15,d29; Radiotherapy:PTV/PGTV:50.4Gy/59.92Gy/28f.

Locations (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China