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A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Chemoimmunotherapy

NCT07530549 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-15

No results posted yet for this study

Summary

The goal of this clinical trial is Iparomlimab and tuvonralimab (QL1706) combined with chemoradiotherapy in the treatment of locally advanced esophageal cancer after failed neoadjuvant chemoimmunotherapy. The main question it aims to answer is： Can it bring survival benefits and safet to patients？Subsequent evaluation will determine whether the patient undergoes surgical treatment. Follow-up will be conducted to assess the efficacy and safety of the treatment。

Conditions

  • Local Advanced Esophageal Cancer

Interventions

DRUG

QL1706

QL1706(Iparomlimab and Tuvonralimab Injection): 5.0 mg/kg Q3W for 2 cycles; Radiotherapy Prescription Dose: 95% PGTV 40-50 Gy/20-25 fractions; Tegafur: 40-60 mg/m² twice daily (d1-14) every 3 weeks for 2 cycles; Evaluation for surgery: Patients will be divided into surgical and non-surgical groups. Participants who are not candidates for surgery may receive sequential boost radiotherapy to PGTV at a about dose of 60 Gy. Following radiotherapy, maintenance treatment with immunotherapy combined with chemotherapy will be administered for up to one year, until disease progression, death, or the occurrence of intolerable toxicity.

Sponsors & Collaborators

  • The Luhe Teaching Hospital of the Capital Medical University

    collaborator OTHER

  • Beijing Chest Hospital, Capital Medical University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    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
2026-04-01
Primary Completion
2027-12-31
Completion
2028-08-31

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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 NCT07530549 on ClinicalTrials.gov