RecruitingPhase 2NCT06356688

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

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)

Sponsor

Sun Jing

Enrollment

30 participants

Start Date

Apr 20, 2025

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy Locally Advanced Esophageal Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of treatments given before surgery for locally advanced esophageal squamous cell carcinoma. Patients will receive a newer form of paclitaxel (packaged in tiny particles called polymeric micelles), cisplatin (chemotherapy), and cadonilimab (an immunotherapy drug) to try to shrink the tumor before it is surgically removed. **You may be eligible if...** - You are 18–75 years old with a confirmed diagnosis of esophageal squamous cell carcinoma (thoracic segment) - Your cancer is locally advanced (Stage II, III, or IVA) and potentially removable by surgery - You have not had any prior cancer treatment (no radiation, chemotherapy, or immunotherapy) - You are in good physical condition (ECOG score 0 or 1) with an expected survival over 6 months - Your blood counts, liver, kidney, and heart function are adequate **You may NOT be eligible if...** - You have had prior cancer treatment of any kind - You have autoimmune disease, immunodeficiency, or require ongoing steroid therapy - You have a history of other cancers - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel 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;