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Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell

NCT06006650 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-08-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin

Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Principal Investigators

  • Xiaolong Yan, MD · Tang-Du Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06006650 on ClinicalTrials.gov