NCT07490002

Neoadjuvant Therapy With Iparomlimab and Tuvonralimab, Lenvatinib and Chemotherapy in Resectable ESCC

A Phase II Clinical Study of Neoadjuvant Therapy With Epacadostat, Lenvatinib, and Chemotherapy in Surgically Resectable Esophageal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, exploratory clinical study.

Detailed description

This study is a single-arm, single-center, prospective clinical trial. A total of 33 subjects are planned to be enrolled. The study consists of a screening period, a treatment period, and a post-treatment follow-up period. After providing signed informed consent and meeting eligibility criteria, subjects will receive neoadjuvant therapy with epacadostat, tovorafenib, lenvatinib, cisplatin/carboplatin, and nab-paclitaxel. Treatment will be administered in 3-week cycles, with a total of 3 preoperative cycles (lenvatinib will be discontinued in the third cycle).

Conditions

• Esophageal Squamous Carcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel	Iparomlimab and Tuvonralimab: 5 mg/kg, Day 1; Lenvatinib: 8 mg, orally, once daily (QD), Day 1-14; Note: Lenvatinib will be discontinued starting from Cycle 3. Cisplatin: 75 mg/m², or Carboplatin: AUC 5, intravenously (IV), Day 1; Nab-paclitaxel: 125 mg/m², Day 1 and Day 8; The cycle repeats every 3 weeks.

Timeline

• Start date: 2026-04-06
• Primary completion: 2028-11-30
• Completion: 2030-11-30
• First posted: 2026-03-24
• Last updated: 2026-03-24