Shandong Provincial Hospital
Jinan, Shandong, 250000, China
Location status: Recruiting
NCT Number: NCT06908382
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Jinan, Shandong, 250000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: one month after esophageal cancer surgery
The rate of patients with primary tumor and lymph nodes both achieved pathological complete response
Time frame: one month after esophageal cancer surgery
The percentage of subjects with less than 10% tumor residue in the primary tumor site
Time frame: approximately 5 years
The time from initial drug use to the occurrence of events as defined by the study protocol
Time frame: approximately 6 years
The time from initial drug use to death due to any cause
Time frame: From initial drug use to one month after surgery
Rate of adverse event and severe event according to CTCAE 5.0
Contact information is provided by the study sponsor or research team.
Shandong Provincial Hospital
Other Gov
A Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.