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.
This clinical study aims 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.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Iparomlimab 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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
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.
Time frame: up to 6 month
Major Pathologic Response rate (MPR)
Time frame: up to 12 month
R0 Resection rate
Time frame: up to 12 month
Event-Free Survival (EFS)
Time frame: up to 12 month
Disease-Free Survival (DFS)
Time frame: up to 12 month
Overall survival
Os was defined as the time from the first dose of study drug to death due to anycause.
Time frame: up to 36 month
Adverse Events
An AE was defined as any untoward medical occurrence in a pharmaceutical productwhich does not necessarily have to have a causal relationship with this treatment.
Time frame: up to 36 month
Chang Liu
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.