Resection for Esophageal Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Esophageal Squamous Cell Carcinoma+25 More
Resection - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the effect of giving chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery to treat patients with esophageal or esophageal/gastroesophageal junction cancer that has not spread to other places in the body.

Eligible Conditions
  • Esophageal Squamous Cell Carcinoma
  • Squamous cell carcinoma of esophagus
  • Adenocarcinoma
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Adenocarcinoma Of Esophagus
  • Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Esophageal Squamous Cell Carcinoma

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 3 years

Week 14
Clinical complete response (CR)
Pathological complete response (CR)
Up to 3 years
Disease
Immune-mediated tumor cytotoxicity
Overall survival (OS)
Day 90
Incidence of adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Esophageal Squamous Cell Carcinoma

Trial Design

1 Treatment Group

Treatment (chemoradiation, pembrolizumab, lenvatinib)
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Resection · No Placebo Group · Phase 2

Treatment (chemoradiation, pembrolizumab, lenvatinib)Experimental Group · 7 Interventions: Pembrolizumab, Paclitaxel, External Beam Radiation Therapy, Resection, Carboplatin, Endoscopic Biopsy, Lenvatinib Mesylate · Intervention Types: Biological, Drug, Radiation, Procedure, Drug, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Paclitaxel
FDA approved
External Beam Radiation Therapy
2006
Completed Phase 3
~2470
Resection
2021
Completed Phase 2
~400
Carboplatin
FDA approved
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,864 Total Patients Enrolled
20 Trials studying Esophageal Squamous Cell Carcinoma
2,248 Patients Enrolled for Esophageal Squamous Cell Carcinoma
City of Hope Medical CenterLead Sponsor
505 Previous Clinical Trials
2,249,003 Total Patients Enrolled
4 Trials studying Esophageal Squamous Cell Carcinoma
44 Patients Enrolled for Esophageal Squamous Cell Carcinoma
Joseph ChaoPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
105 Total Patients Enrolled
2 Trials studying Esophageal Squamous Cell Carcinoma
24 Patients Enrolled for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have non-metastatic cancer of the esophagus or GEJ.
You have informed consent of the participant and/or legally authorized representative.
You are receiving weekly carboplatin/paclitaxel.
Radiation therapy as defined as external beam radiotherapy defined as: 50.4 Gy as per institutional and national treatment guidelines.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.