Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
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.
Conditions
This trial is treating people with Oesophageal Cancer
Eligibility
Inclusion
- Pathologically (histologically) confirmed diagnosis of ESCC
- Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.
Exclusion
- Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
- Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
- Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
- Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention)
- Evidence of complete esophageal obstruction not amenable to treatment
- Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) < 83.5 per investigator's choice
- Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.
- Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
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
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