NCT07530549

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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。

Detailed description

Participants were treated with QL1706 and radical CCRT.After receiving the combination of QL1706 with radical CCRT, patients who are eligible for surgery will undergo the procedure, while those 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.

Conditions

• Local Advanced Esophageal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2028-08-31
• First posted: 2026-04-15
• Last updated: 2026-04-15