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NCT04522336
Pembrolizumab and Chemoradiotherapy for the Treatment of Unresectable Gastroesophageal Cancer
Phase 1 trial testing Docetaxel in Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 in 16 participants. Participants enrolled and being followed up; not accepting new ones.
18 July 2027
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 16 September 2020 |
| Primary completion | 18 July 2027 |
| Estimated completion | 18 July 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Docetaxel (Docetaxel) — full drug profile →
- Fluorouracil — full drug profile →
- Oxaliplatin (Oxaliplatin) — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
- Radiation Therapy
Conditions studied
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 — all drugs for Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 →
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 — all drugs for Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 →
- Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 — all drugs for Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 →
- Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 — all drugs for Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 or Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current state of the art: immunotherapy in esophageal cancer and gastroesophageal junction cancer.
Li N, Sohal D. · · 2023 · cited 22× · PMID 37995002 · DOI 10.1007/s00262-023-03566-5 -
Update of latest data for combined therapy for esophageal cancer using radiotherapy and immunotherapy: A focus on efficacy, safety, and biomarkers.
Cheng S, Li B, Yu J, Wang L. · · 2023 · cited 6× · PMID 37969961 · DOI 10.21147/j.issn.1000-9604.2023.05.06
Verify or expand the search:
- PubMed search for NCT04522336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04522336 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 5 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04522336.
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