NCT03783442 : A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Oesophagus<br/>CancersCancer LocationOesophagus
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractOesophagus

Trial Overview Read MoreRead more

This phase III trial trying to determine how safe and effective an immunotherapy drug (Tislelizumab) is as a first line treatment, in combination with chemotherapy, in patients with advanced Oesophageal .
 

This trial is treating patients with Oesophageal Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Commercial Sponsor

BeiGene Australia Pty Ltd

Summary

Eligible participants will be randomised to receive either Tislelizumab (200 mg IV on Day 1, every 21 days) or a placebo, in combination with one of the following recommended chemotherapy regimens: (1) Intravenous cisplatin 60-80 mg/m2 in combination with intravenous fluorouracil 750-800 mg/m² on Day 1 and 5, every three weeks (Q3W), (2) Intravenous cisplatin 60-80 mg/m2 on Day 1 and 5, plus oral capecitabine 1000 mg/m2 twice a day on Days 1-14, Q3W or (3)Intravenous cisplatin 60-80 mg/m2 on Day 1 or 2 (or 1-3) plus paclitaxel 175 mg/m² IV on Day 1, Q3W.

Recruiting Hospitals Read MoreRead more

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9288 3167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next