Tislelizumab plus chemo in first-line Oesophageal Squamous Cell Cancer
Research type
Research Study
Full title
A Randomised, 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 Oesophageal Squamous Cell Carcinoma
IRAS ID
252786
Contact name
Jemma Capuozzo
Contact email
Sponsor organisation
BeiGene, Ltd.
Eudract number
2018-000587-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 27 days
Research summary
Oesophageal cancer is the eighth most common cancer worldwide and the sixth most common cause of death from cancer.
If oesophageal cancer is diagnosed at an early stage, it may be possible to cure it with:
· surgery to remove the affected section or all of the oesophagus
· chemotherapy with radiotherapy (chemoradiation) or without radiotherapy, to kill the cancerous cells and shrink the tumour
If oesophageal cancer is diagnosed at a later stage, a cure may not be achievable. In these cases, surgery, chemotherapy, and radiotherapy can be used to help keep the cancer under control and relieve any symptoms the patients have. Only patients with advanced/ late-stage disease will be participating in this study.
The aim of the study is to evaluate and compare the progression free survival (i.e., the amount of time a patient can live with cancer without it getting worse) and overall survival of patients following treatment with tislelizumab plus chemotherapy versus placebo plus chemotherapy.
The study is double-blinded, so neither the patient nor the study doctor will know whether tislelizumab or placebo has been administered. Patients will be randomised 50:50 to receive either tislelizumab or placebo.
Tislelizumab is a monoclonal antibody acting on PD-1. A monoclonal antibody is a type of protein made in the laboratory which can be “programmed” to bind to specific substances in the body or on cells, like cancer cells. PD-1, called programmed cell death -1, is a protein present on the surface of immune cells. When binding to its ligand, PD-1 can inhibit the killing of tumour cells by immune cells. Tislelizumab can act on PD-1 instead of its ligand, thereby stopping its negative effect on the immune cells, so that immune cells are free to attack tumour cells.
The chemotherapy drugs that the patient may receive in this research study are a platinum drug (cisplatin or oxaliplatin), a fluoropyrimidine (capecitabine or 5-fluorouracil) and a taxane (paclitaxel). All five of these drugs are considered the standard of care in the UK for patients with advanced unresectable or metastatic oesophageal squamous cell carcinoma.
This study is taking place in the UK and other countries. The Sponsor of the study is BeiGene, Ltd. Around 480 patients are expected to be involved in the trial.REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0130
Date of REC Opinion
3 Jun 2019
REC opinion
Further Information Favourable Opinion