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NOT YET RECRUITING
NCT07618910
PHASE2

Retlirafusp Alfa Plus Chemotherapy as Neoadjuvant Therapy for Thoracic ESCC

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with chemotherapy (nab-paclitaxel and cisplatin) as a neoadjuvant therapy for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC). The primary objective of this study is to assess the pathologic complete response (pCR) rate in the target population. A total of 33 patients with histologically or cytologically confirmed resectable locally advanced thoracic ESCC are planned to be enrolled.

Official title: A Prospective, Single-Arm, Exploratory Study of Retlirafusp Alfa Combined With Chemotherapy as Neoadjuvant Therapy for Thoracic Esophageal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-05-30

Completion Date

2028-05-30

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

Retlirafusp alfa

Administered at a fixed dose of 1800 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles. Retlirafusp alfa must be infused first in the sequence, with an interval of at least 30 minutes before the subsequent administration of nab-paclitaxel.

DRUG

Nab paclitaxel

Administered at a dose of 130 mg/m² via intravenous (IV) infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 3 cycles.

DRUG

Cisplatin for injection

Administered at a dose of 75 mg/m² via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles.

Locations (1)

Tangdu Hospital Affiliated to the Fourth Military Medical University

Xi'an, Shaanxi, China