A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Recruiting Phase 3 Interventional Study
Esophageal Squamous Cell Carcinoma
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 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
510 (estimated)
Sponsor
Shandong Boan Biotechnology Co., Ltd · Industry
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About This Trial

This is a randomized, double-blind, multicenter, Phase 3 study to compare the efficacy and safety of LY01015 and Opdivo®(Nivolumab Injection)combined respectively with fluorouracil plus cisplatin in participants with unresectable advanced, recurrent or metastatic previously untreated esophageal squamous cell carcinoma.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Willing to sign the informed consent form. 2. Male or female aged 18 to 75 years patients. 3. Histopathologically confirmed esophagus squamous cell carcinoma. 4. Diagnosed with advanced or metastatic ESCC per AJCC 8th edition, not be amenable to curative approaches( such as d…
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