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RECRUITING
NCT06006650
PHASE2

Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2022-08-01

Completion Date

2031-12-31

Last Updated

2023-08-23

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab, 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