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NCT05357846
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Phase 3 trial testing Sintilimab in Squamous Cell Esophageal Carcinoma in 422 participants. Currently enrolling.
1 January 2031
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 422 |
| Start date | 1 November 2022 |
| Primary completion | 1 January 2031 |
| Estimated completion | 31 January 2031 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab — full drug profile →
- Preoperative radiotherapy
- Paclitaxel — full drug profile →
- Cisplatin (cisplatin) — full drug profile →
- esophagectomy
Conditions studied
- Squamous Cell Esophageal Carcinoma — all drugs for Squamous Cell Esophageal Carcinoma →
- Esophageal Cancer — all drugs for Esophageal Cancer →
- Oesophageal Cancer — all drugs for Oesophageal Cancer →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Squamous Cell Esophageal Carcinoma or Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
Publications & conference data
8 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 -
Recent developments in immunotherapy for gastrointestinal tract cancers.
Chong X, Madeti Y, Cai J, Li W, et al · · 2024 · cited 52× · PMID 39123202 · DOI 10.1186/s13045-024-01578-x -
Neoadjuvant immunotherapy for resectable esophageal cancer: A review.
Li Q, Liu T, Ding Z. · · 2022 · cited 43× · PMID 36569908 · DOI 10.3389/fimmu.2022.1051841 -
Immune evasion in esophageal squamous cell cancer: From the perspective of tumor microenvironment.
Li R, Huang B, Tian H, Sun Z. · · 2022 · cited 33× · PMID 36698392 · DOI 10.3389/fonc.2022.1096717 -
Current status and perspectives of esophageal cancer: a comprehensive review.
Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645 -
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 -
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 -
Perioperative immunotherapy for esophageal squamous cell carcinoma: Now and future.
Liu Y. · · 2023 · cited 16× · PMID 37753366 · DOI 10.3748/wjg.v29.i34.5020
Verify or expand the search:
- PubMed search for NCT05357846
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Sun Yat-sen University trials
Trials by the same sponsor.
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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 NCT05357846 (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: 12 June 2025
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/NCT05357846.
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