Major objectives to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.
Voluntarily understand and sign the informed consent form for this study.
Age ≥ 18 years, male or female.
Histologically or cytologically confirmed thoracic ESCC (Stage T1-2N1-2M0 or T3N0-2M0, according to the AJCC 8th edition).
ECOG performance status of 0-2.
Inability to comply with the study protocol or study procedures.
Presence of supraclavicular lymph node metastasis.
Obvious tumor invasion of organs adjacent to the esophageal lesion.
Evidence of esophagomediastinal or tracheoesophageal fistula found on imaging within 4 weeks before enrollment.
Single group
lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel
DrugIparomlimab and Tuvonralimab Injection: 5 mg/kg, q3w; Nab-Paclitaxel: 125 mg/m² on d1 and d8, q3w; Neoadjuvant therapy is administered for 4 cycles. The appropriate surgical timing will be determined by the physician based on the patient's condition, and surgery is scheduled for 4-6 weeks after the completion of neoadjuvant therapy.
Pathologic complete response rate (pCR)
refers to the absence of viable tumor cells in both the primary tumor bed and the regional lymph nodes in the surgically resected specimens.
Major Pathologic Response rate (MPR)
R0 Resection rate
Event-Free Survival (EFS)
Disease-Free Survival (DFS)
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