RecruitingPhase 2NCT06006650

Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell

Pembrolizumab Plus Albumin Paclitaxel or 5-fluorouracil and Cisplatin Versus 5-fluorouracil and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Prospective, Randomized Controlled Trial Study

Sponsor

Tang-Du Hospital

Enrollment

114 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Esophageal Squamous Cell Carcinoma PD-1 Inhibitor Neoadjuvent

Summary

The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy and immunotherapy given before surgery (neoadjuvant) in patients with resectable esophageal squamous cell carcinoma at stages II through IVa. **You may be eligible if:** - You are between 18 and 75 years old - You have confirmed esophageal squamous cell carcinoma at stage II–IVa - You have not had prior immunotherapy or chemoradiotherapy for this cancer - You are in good general health (ECOG 0–1) and your blood, liver, kidney, and lung function are within normal ranges **You may NOT be eligible if:** - Your cancer is a mixed or rare type (not pure squamous cell carcinoma) - You have had a heart attack within the past year or have unstable heart disease - You are pregnant, nursing, or of childbearing age without adequate contraception - You have poorly controlled diabetes or lung function that is too low for surgery 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

DRUGPembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin

Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin

Locations(3)

Tangdu Hospital of the Fourth Millitary Medical University

Xi'an, Shaanxi, China

Hongtao Duan

Xi’an, Shanxi, China

Tangdu Hospital, the Air Force Military University

Xi'an, China

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NCT06006650

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