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Retlirafusp Alfa Plus Chemotherapy as Neoadjuvant Therapy for Thoracic ESCC

NCT07618910 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2027-05-30
Completion
2028-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618910 on ClinicalTrials.gov