RecruitingPhase 2NCT06452602

Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

60 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests immunotherapy (checkpoint inhibitor) combined with chemotherapy followed by chemoradiation in patients with locally advanced esophageal squamous cell carcinoma (cancer of the food pipe) that cannot be removed surgically. The goal is to shrink the cancer with drugs first, then consolidate with radiation. **You may be eligible if...** - You are 18 or older with confirmed squamous cell cancer of the esophagus at stage II-IVb - Your cancer cannot be removed surgically (inoperable or you have refused surgery) - You have not received any prior treatment for this cancer - You are in good health (ECOG 0 or 1) with adequate blood counts and organ function **You may NOT be eligible if...** - You have received any prior systemic therapy, radiation, or immunotherapy for this cancer - You have uncontrolled infections, autoimmune conditions, or severe organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInduction 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.

DRUGInduction 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.