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Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.

NCT06452602 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Wencheng zhang, M.D. · Tianjin Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06452602 on ClinicalTrials.gov