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A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Chemoimmunotherapy
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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。
Official title: Iparomlimab and Tuvonralimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Chemoimmunotherapy: a Prospective, Single-arm, Multicenter, Phase II Clinical Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-04-01
Completion Date
2028-08-31
Last Updated
2026-04-15
Healthy Volunteers
No
Conditions
Interventions
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.