PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Recruiting Phase 3 Interventional Study
Squamous Cell Esophageal Carcinoma Esophageal Cancer Oesophageal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
422 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable. 2. Patients must not have received any prior anticancer therapy. 3. More than 6 months of expected survival. 4. Age ranges from 18 to 70 year…
Contacts

HONG YANG, M.D. Ph.D.

8602087343

yanghong@sysucc.org.cn

CONTACT