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。
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Event-free Survival(EFS)
time from treatment to disease progression, local or distant recurrence, or death
Time frame: From enrollment to the end of monitoring at 2 years
Overall Survival (OS)
The time from the start of treatment to death from any cause
Time frame: From enrollment to the end of monitoring at 2 years
Progression-Free Survival(PFS)
time from treatment to the first documented disease progression or death
Time frame: From enrollment to the end of monitoring at 2 years
Adverse reaction
Time frame: From the start of treatment to within 90 days after the end of treatment.
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