RecruitingPhase 2NCT06908382

Neoadjuvant QL1706 Therapy for ESCC

A Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma


Sponsor

Shandong Provincial Hospital

Enrollment

32 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study plans to enroll 32 patients with resectable esophageal squamous cell carcinoma. The treatment regimen consists of Iparomlimab and Tuvonralimab(QL1706) combined with chemotherapy: intravenous infusion of QL1706 (5 mg/kg, q3w) in combination with albumin-bound paclitaxel (260 mg/m² on day 1, q3w) plus cisplatin (75 mg/m² on day 1, q3w) or carboplatin (AUC 5 on day 1, q3w) for 3 cycles. Surgical resection will be performed 3-6 weeks after treatment completion. Pre-treatment and surgical tissue specimens will be collected for analysis of tumor immune microenvironment changes using digital gene quantification technology. Peripheral blood samples will be obtained for dynamic ctDNA monitoring at four time points: within 7 days pre-treatment, 7 days pre-surgery, 7-30 days post-surgery, and 6 months post-surgery. The primary endpoint is the pathological complete response (pCR) rate, and secondary endpoints include major pathological response (MPR) and adverse reactions.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called QL1706 (a combination immunotherapy) given before surgery in people with esophageal squamous cell carcinoma (a type of food pipe cancer), to see how well it helps shrink the tumor ahead of the operation. **You may be eligible if...** - You are between 18 and 75 years old - You have esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is locally advanced (specific stages as confirmed by your doctor) and you are planned for surgery after treatment - You are in good overall health (ECOG 0 or 1) **You may NOT be eligible if...** - You have an active autoimmune disease (such as lupus, inflammatory bowel disease, autoimmune hepatitis, or similar conditions) - You currently have or recently had severe asthma requiring treatment - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIparomlimab and Tuvonralimab Injection

QL1706 (5 mg/kg, q3w) +Paclitaxel for injection (albumin bound) (260mg/m2 D1, q3w)+cisplatin (75mg/m2 D1, q3w)/carboplatin (AUC 5 D1) , 3 cycles


Locations(1)

Shandong Provincial Hospital

Jinan, Shandong, China

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NCT06908382