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NCT06601309: ESCC
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Phase 2 trial testing Serplulimab in Esophageal Squamous Cell Carcinoma in 90 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | Fujian Medical University Union Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 11 July 2024 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Serplulimab — full drug profile →
- Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy) — full drug profile →
- Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy) — full drug profile →
- Radiotherapy — full drug profile →
Conditions studied
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
Sponsor
Fujian Medical University Union Hospital
Who can join
Adults 18 to 75, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immune biomarkers for head and neck cancer.
Sobhani N, D'Angelo A, Kugeratski FG, Nguyen T, et al · · 2025 · cited 1× · PMID 41410866 · DOI 10.1007/s00262-025-04233-7 -
The safety and efficacy of neoadjuvant immunochemotherapy in locally advanced esophageal squamous cell carcinoma: a meta-analysis and systematic review.
Shen Q, Liu H, Xue H, Yilixiati A, et al · · 2026 · PMID 41743735 · DOI 10.3389/fimmu.2026.1687326
Verify or expand the search:
- PubMed search for NCT06601309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Serplulimab
Trials testing the same drug.
- NCT07466303 — Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07446465 — FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectab · Phase 4 · not yet recruiting
- NCT07403435 — Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC · Phase 2 · not yet recruiting
- NCT07381400 — Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Stu · Phase 2 · not yet recruiting
- NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
Other recruiting trials for Esophageal Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07385001 — A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as N · Phase 1, PHASE2 · recruiting
- NCT07217171 — A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial · Phase 1 · recruiting
- NCT07109726 — A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations · Phase 1, PHASE2 · recruiting
- NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting
Other Fujian Medical University Union Hospital trials
Trials by the same sponsor.
- NCT07406815 — The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Inva · Phase 3 · not yet recruiting
- NCT07444983 — Rezvilutamide for High-Risk Prostate Cancer After Surgery · NA · not yet recruiting
- NCT07493070 — Ultra-stable Iodized Oil-Chemo Embolization Seq Thermal Ablation in Early Liver Ca · NA · active not recruiting
- NCT07389889 — Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nod · NA · not yet recruiting
- NCT07303231 — The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esoph · Phase 3 · 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 NCT06601309 (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 Fujian Medical University Union Hospital
- Last refreshed: 15 September 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/NCT06601309.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing