Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With… (NCT07493993) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
China26 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* No prior treatment for esophageal squamous cell carcinoma.
* Life expectancy ≥ 3 months.
* Adequate function of major organs within 7 days before the first treatment (use of any blood components or cell growth factors within 14 days before enrollment is not permitted):Hemoglobin ≥ 90 g/L; White blood cell count ≥ 3.5 × 10\^9/L; Absolute neutrophil count ≥ 1.5 × 10\^9/L; Platelets ≥ 80 × 10\^9/L; AST and ALT ≤ 2.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance (CCr) ≥ 50 mL/min); Left ventricular ejection fraction (LVEF) ≥ 50%.
* Fertile patients must agree to use reliable contraceptive methods with their partner during the trial and for at least 180 days after the last dose.
Exclusion Criteria:
* 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.
* Allergy or known hypersensitivity to the study drugs or their excipients.
* Anticipated need for systemic corticoste…
What they're measuring
1
Pathologic complete response rate (pCR)
Timeframe: up to 6 month
Trial details
NCT IDNCT07493993
SponsorTianjin Medical University Cancer Institute and Hospital