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NCT05512520: EC-CRT-003
Concurrent Chemoradiotherapy for Stage IVB Esophageal Squamous Cell Carcinoma（EC-CRT-003）
Phase 2 trial testing Intensity-modulated radiotherapy concurrent with capecitabine in Metastatic Esophageal Squamous Cell Carcinoma in 126 participants. Status unknown.
30 August 2024
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 126 |
| Start date | 20 September 2022 |
| Primary completion | 30 August 2024 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Intensity-modulated radiotherapy concurrent with capecitabine
Conditions studied
- Metastatic Esophageal Squamous Cell Carcinoma — all drugs for Metastatic Esophageal Squamous Cell Carcinoma →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Metastatic Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Retrospective studies suggested that the addition of thoracic concurrent chemoradiotherapy to systemic chemotherapy improved the survival and quality of life (QOL) of patients with metastatic esophageal squamous cell carcinoma (ESCC). However, no prospective study had been conducted to confirm these findings. Recently, immunotherapy targeting the PD-1/PD-L1 checkpoints combined with chemotherapy had been proved to significantly prolong the survival of those patients compared with chemotherapy alone. Moreover, anti-PD-1 combined with radiotherapy exerts a synergistic anti-tumor effect, which may further improve the combination efficacy. This randomized, phase II study aimed to evaluate the efficacy and safety of the chemotherapy and anti-PD-1 combined with concurrent chemoradiotherapy to primary tumor versus systemic therapy alone in stage IVB ESCC. Of note, non-regional lymph node metastasis only was the stratification factor in the random assignment.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mechanisms of radiotherapy resistance and radiosensitization strategies for esophageal squamous cell carcinoma.
An L, Li M, Jia Q. · · 2023 · cited 129× · PMID 37598158 · DOI 10.1186/s12943-023-01839-2 -
Radiotherapy combined with immune checkpoint inhibitors in locally advanced/metastatic esophageal squamous cell carcinoma: clinical trials, efficacy and future directions.
Jiang M, Hu Y, Lin G, Chen C, et al · · 2023 · cited 18× · PMID 37325652 · DOI 10.3389/fimmu.2023.1177085 -
Current and future on definitive concurrent chemoradiotherapy for inoperable locally advanced esophageal squamous cell carcinoma.
Xie R, Cai Q, Chen T, Huang H, et al · · 2024 · cited 10× · PMID 38344202 · DOI 10.3389/fonc.2024.1303068 -
Opportunities and challenges in combining immunotherapy and radiotherapy in esophageal cancer.
Zhang X, Cai X, Yan C. · · 2023 · cited 6× · PMID 37985502 · DOI 10.1007/s00432-023-05499-z -
A comparison between single and fractionated doses of albumin-bound paclitaxel in the treatment of advanced esophageal cancer: A multicenter case-control study.
Ren J, Wang K, Zhao J, Xu C, et al · · 2024 · cited 1× · PMID 39558764 · DOI 10.1177/00368504241299016
Verify or expand the search:
- PubMed search for NCT05512520
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT04460937 — Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal an · Phase 1 · active not recruiting
- NCT01142388 — Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or · Phase 2 · active not recruiting
Other Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting
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 NCT05512520 (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 Sun Yat-sen University
- Last refreshed: 18 November 2023
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/NCT05512520.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing