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RECRUITING
NCT06356688
PHASE2

A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Sponsor: Sun Jing

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined with chemotherapy.

Official title: A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-Arm, Single-Center, Prospective Clinical Trial (POINTS Trial)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-04-20

Completion Date

2027-10-01

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DRUG

Paclitaxel Polymeric Micelles for Injection and Cisplatin combined with Cadonilimab

Paclitaxel Polymeric Micelles for Injection:Cycle 1: 230mg/m2, IV ≥3 hours; Cycles 2-4: If the patient has a neutrophil nadir ≥1.0 x 109/L along with a platelet nadir ≥80 x 109/L after Cycle 1 dosing and has not experienced grade II-IV non-hematologic toxicity, then give 260mg/m2, IV ≥3 hours, d1, q3w; Cisplatin: 25mg/m2/d x d1-3, IV drip, q3w; Cadonilimab: 10mg/kg, IV drip, d3, q3w;

Locations (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China