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Retlirafusp Alfa Combined With Chemoradiotherapy in Unresectable ESCC

NCT07769866 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-08-18

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of retlirafusp alfa combined with radical chemoradiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma. Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year.

Conditions

  • Esophageal Squamous Cell Cancer

Interventions

DRUG

Induction chemo-immunotherapy

Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy: Retlirafusp alfa 1800mg Day1 + Albumin-bound paclitaxel 125mg/m² Day 1 and Day 8 + Cisplatin 25mg/m² Day 1-3 every 3 weeks (Q3w)

RADIATION

Concurrent chemoradiotherapy (cCRT)

Radiation: 1.8Gy/Fx, total dose (DT) 50.4Gy/28Fx; Chemotherapy: Albumin-bound paclitaxel 60-80mg/m² + Cisplatin 25mg/m² Day 1 every week (Qw)

DRUG

maintenance immunotherapy

Retlirafusp Alfa 1800 mg on Day 1, Q3W, as maintenance therapy until disease progression or unacceptable toxicity, for up to 1 year; the total number of cycles for Retlirafusp Alfa induction and maintenance therapy should not exceed 15 cycles.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

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
2026-09-01
Primary Completion
2029-06-30
Completion
2030-06-30

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 NCT07769866 on ClinicalTrials.gov