RecruitingPhase 2NCT06304350

Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

A Single Arm, Single Center, Phase II Clinical Study of Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma


Sponsor

Tongji University

Enrollment

25 participants

Start Date

Feb 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug pembrolizumab to standard pre-surgery chemotherapy (albumin paclitaxel + carboplatin) improves outcomes for people with stage II or III esophageal squamous cell cancer that can be surgically removed. **You may be eligible if...** - You have been diagnosed with stage II or III squamous cell cancer of the esophagus that is eligible for surgery - You have not previously received any treatment for esophageal cancer - You are between 18 and 75 years old - Your blood counts, liver, and kidney function meet the study's lab requirements - Your doctors expect surgery can fully remove the cancer - You have a good general health status (ECOG 0-1) **You may NOT be eligible if...** - You have previously received surgery, chemotherapy, radiation, or immunotherapy for esophageal cancer - You are pregnant or breastfeeding - You have active autoimmune diseases requiring treatment - You have poorly controlled heart disease - You have had prior treatment with a PD-1/PD-L1 immunotherapy drug - You are allergic to any medications in the study 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

DRUGCombination of pembrolizumab and platinum containing dual drugs

After 2 courses of treatment with a combination of pembrolizumab and platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab immunomaintenance therapy continued after surgery


Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT06304350


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