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NOT YET RECRUITING
NCT07112833
PHASE2

A Phase II Clinical Study of Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)

Sponsor: Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT or RECIST1.1 assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-08-10

Completion Date

2027-12-31

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DRUG

Induction stage:Adebrelimab+TC;Treatment stage: TC/PF+ radiation therapy;Maintenance stage: Adebrelimab

Induction stage:Adebrelimab+TC: Adebrelimab : 1200mg d1, iv, q3w ; TC : paclitaxel 135mg/m2, or nab-paclitaxel paclitaxel 180mg/m2, d1, iv,carboplatin AUC=5, d1, iv, q3w,2 cycles. Treatment stage: TC/PF+ radiation therapy: PET-CT responders (SUV (PETr) reduction ≥35%): TC/PF+ radiation therapy: TC : paclitaxel 50mg/m2, nab-paclitaxel paclitaxel 60mg/m2, d1, iv; carboplatin AUC=2, d1, iv, qw,5 cycles. PF : fluorouracil 750-1000mg/m2, CIV 96 hours,cisplatin 75mg/m2, d1, iv, q4w,2 cycles. Radiation therapy: 50.4Gy-60Gy/28-33f. PET-CT non-responders (SUV (PETr) reduction \<35%):(switch to a different chemotherapy drug which not used during the earlier induction phase) PF/TC+ radiation therapy: dose same as above. Maintenance stage: Adebrelimab: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs(Up to one year).

Locations (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China