A Phase 2 interventional study of Iparomlimab and Tuvonralimab Injection in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma, sponsored by Shandong Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Shandong Provincial Hospital · Phase 2, Interventional, and Treatment
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.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's planned enrollment of 32 is below the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Shandong Provincial Hospital is the lead sponsor of 58 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Drug: Iparomlimab 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
pCR Rate
The rate of patients with primary tumor and lymph nodes both achieved pathological complete response
Time frame: one month after esophageal cancer surgery
MPR Rate
The percentage of subjects with less than 10% tumor residue in the primary tumor site
Time frame: one month after esophageal cancer surgery
EFS
The time from initial drug use to the occurrence of events as defined by the study protocol
Time frame: approximately 5 years
OS
The time from initial drug use to death due to any cause
Time frame: approximately 6 years
Safety (adverse event)
Rate of adverse event and severe event according to CTCAE 5.0
Time frame: From initial drug use to one month after surgery
Plan to share: No
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Shandong Provincial Hospital