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NCT04522336 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab and Chemoradiotherapy for the Treatment of Unresectable Gastroesophageal Cancer
A Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04522336: Active Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04522336 is a Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 97-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04522336, a Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial investigates how well pembrolizumab and chemoradiotherapy works in treating patients with gastroesophageal cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as fluorouracil, oxaliplatin and docetaxel 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 photons to kill tumor cells and shrink tumors. Giving pembrolizumab together with chemoradiotherapy may help to control gastroesophageal cancer.
Primary Outcome
cCR, defined as at the time of post-chemoradiation staging, there is no evidence of cancer on endoscopic examination/histology/cytology and there is no evidence of cancer by imaging modality. Tumor assessment will be conducted every 9 weeks until the 54th week of the study and every 12 weeks after that. The best response will be recorded.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Docetaxel
- DRUG Fluorouracil
- DRUG Oxaliplatin
- RADIATION Radiation Therapy
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2027-07-18 |
| Phase | Phase 1 |
What the registry record for NCT04522336 still lists
NCT04522336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 97-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (84% lower).
The record links to 10 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04522336 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04522336 about?
NCT04522336 is a clinical study titled "Pembrolizumab and Chemoradiotherapy for the Treatment of Unresectable Gastroesophageal Cancer". This phase I trial investigates how well pembrolizumab and chemoradiotherapy works in treating patients with gastroesophageal cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer,...
What is the current status of trial NCT04522336?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-09-16. Estimated completion is 2027-07-18.
What conditions does trial NCT04522336 study?
This clinical trial studies the following conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Locally Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8.
What interventions are being tested in trial NCT04522336?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Docetaxel (DRUG), Fluorouracil (DRUG), Oxaliplatin (DRUG), Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04522336?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04522336 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04522336's enrollment target sits among peer trials
16 15th of 19 higher than 4 of 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 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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