Active — Not RecruitingPhase 2

Ipromlimab and Tuvonralimab Combined With Albumin-Bound Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

China62 participantsStarted 2025-12-17

Plain-language summary

This is a Phase II, single-arm clinical study designed to evaluate the efficacy and safety of Ipromlimab combined with Tuvonralimab, plus Albumin-Bound Paclitaxel and Nedaplatin, as neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Upper thoracic esophagus: From the thoracic inlet to the lower border of the aortic arch, corresponding to 20-25 cm from the incisors by endoscopy.
✓. Middle thoracic esophagus: From the lower border of the aortic arch to the level of the inferior pulmonary veins, corresponding to 25-30 cm from the incisors by endoscopy.
✓. Lower thoracic esophagus: From the level of the inferior pulmonary veins to the stomach, including the gastroesophageal junction, corresponding to 30-40 cm from the incisors by endoscopy.
✓. Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥9.0 g/dL.
✓. Biochemistry: Total bilirubin \<1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 × ULN; Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 mL/min.
✓. Coagulation: International normalized ratio (INR) ≤1.5; Activated partial thromboplastin time (APTT) ≤1.5 × ULN.

What they're measuring

PCR

Timeframe: Pathologic Complete Response(pCR) Rate Defined as the proportion of participants with no residual viable tumor cells in the resected surgical specimen. ITime Frame: assessed up to 30 days post-surgery

Trial details

NCT IDNCT07374003

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06-20

View on ClinicalTrials.gov More Locally Advanced, Resectable trials