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NCT04929392 · ClinicalTrials.gov registry record · Phase 2
Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for the Treatment of Non-metastatic Esophageal or Esophageal/Gastroesophageal Junction Cancer
A Phase 2 study of Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT04929392: Active Phase 2 study of Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma, sponsored by City of Hope Medical Center.
NCT04929392 is a Phase 2 study of Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 3 participants, below the 308-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04929392, a Phase 2 study of Esophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effect of chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery in treating patients with esophageal or esophageal/gastroesophageal junction cancer that has not spread to other places in the body (non-metastatic). Pembrolizumab is an immunotherapy drug that works by harnessing the immune system to attack cancer. Lenvatinib is an anti-cancer drug that works by stopping or slowing down the growth of cancer cells. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery may kill more tumor cells.
Primary Outcome
Defined as no residual cancer cells, including lymph nodes under pathologic examination of the surgically resected specimen and/or a Tumor Regression Score of 0 by the College of American Pathologist (CAP) Cancer Protocol for Esophageal Carcinoma. Pathological CR rate will be estimated by the proportion of patients achieving pathological CR, along with the 95% exact binomial confidence interval.
Conditions Studied
Interventions
- DRUG Carboplatin
- RADIATION External Beam Radiation Therapy
- DRUG Paclitaxel
- DRUG Lenvatinib Mesylate
- PROCEDURE Endoscopic Biopsy
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2027-04-25 |
| Phase | Phase 2 |
What the registry record for NCT04929392 still lists
NCT04929392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 308-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (99% lower).
The record links to 10 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04929392 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04929392 about?
NCT04929392 is a clinical study titled "Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for the Treatment of Non-metastatic Esophageal or Esophageal/Gastroesophageal Junction Cancer". This phase II trial studies the effect of chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery in treating patients with esophageal or esophageal/gastroesophageal junction cancer that has not spread to other places in the body (non-metastatic). Pembrolizumab is an...
What is the current status of trial NCT04929392?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2022-01-25. Estimated completion is 2027-04-25.
What conditions does trial NCT04929392 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8.
What interventions are being tested in trial NCT04929392?
The interventions under investigation include: Carboplatin (DRUG), External Beam Radiation Therapy (RADIATION), Paclitaxel (DRUG), Lenvatinib Mesylate (DRUG), Endoscopic Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT04929392?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04929392 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04929392's enrollment target sits among peer trials
3 43rd of 43 higher than 1 of 43 other Esophageal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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