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NCT06006650
Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell
Phase 2 trial testing Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin in Neoadjuvent in 114 participants. Currently enrolling.
31 December 2031
Quick facts
| Lead sponsor | Tang-Du Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 114 |
| Start date | 1 August 2022 |
| Primary completion | 31 December 2031 |
| Estimated completion | 31 December 2031 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin — full drug profile →
Conditions studied
- Neoadjuvent — all drugs for Neoadjuvent →
- PD-1 Inhibitor — all drugs for PD-1 Inhibitor →
- Chemotherapy — all drugs for Chemotherapy →
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
Sponsor
Tang-Du Hospital
Who can join
Adults 18 to 75, any sex, with Neoadjuvent or PD-1 Inhibitor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06006650
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other Tang-Du Hospital trials
Trials by the same sponsor.
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- NCT07354061 — Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC) · Phase 1, PHASE2 · recruiting
- NCT07327736 — Anesthesia Comparison in Early-stage Small NSCLC: A Multicenter RCT · NA · not yet recruiting
- NCT07452601 — Time-of-Day of Immunotherapy Infusion in Neoadjuvant Immunochemotherapy for Thoracic ESCC · Phase 2 · 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 NCT06006650 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tang-Du Hospital
- Last refreshed: 23 August 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/NCT06006650.
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