Your session is about to expire
← Back to Search
Anti-metabolites
Tislelizumab + Chemotherapy for Gastric Cancer
Phase 3
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Locally advanced unresectable or metastatic GC or GEJ carcinoma with histologically confirmed adenocarcinoma
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug against placebo to see if it is more effective at treating gastric or gastroesophageal junction cancer.
Who is the study for?
Adults with inoperable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma can join this trial. They shouldn't have had systemic therapy for their condition yet but may have completed prior therapies without recurrence for at least 6 months. Participants need to be relatively fit (ECOG PS ≤ 1) and have good organ function.Check my eligibility
What is being tested?
The study is testing Tislelizumab combined with chemotherapy against a placebo plus chemotherapy as the first-line treatment. It's a phase 3 trial where participants are randomly assigned to either group in equal numbers, and neither they nor the researchers know who gets which treatment (double-blind).See study design
What are the potential side effects?
Tislelizumab could cause immune-related reactions, fatigue, nausea, liver issues, skin rash and increase infection risk. Chemotherapy agents like Cisplatin and Capecitabine might lead to digestive problems, nerve damage, low blood cell counts causing bruising or infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in the stomach or esophagus and cannot be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30)
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)
Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L)
+8 moreSide effects data
From 2022 Phase 3 trial • 512 Patients • NCT0343084331%
Anaemia
24%
Weight decreased
17%
Cough
16%
Constipation
16%
Decreased appetite
16%
Pyrexia
15%
Aspartate aminotransferase increased
15%
Nausea
14%
Hypoalbuminaemia
13%
Fatigue
13%
Diarrhoea
13%
Alanine aminotransferase increased
12%
Hypothyroidism
12%
Hyponatraemia
11%
Asthenia
11%
Vomiting
11%
Pneumonia
11%
Back pain
10%
Dyspnoea
10%
Pruritus
9%
Rash
9%
Hypokalaemia
9%
Dysphagia
9%
Arthralgia
8%
Insomnia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Abdominal pain
7%
Productive cough
6%
Malaise
5%
White blood cell count increased
5%
Hypoproteinaemia
5%
Gamma-glutamyltransferase increased
5%
Hypertension
5%
Lymphocyte count decreased
5%
Platelet count decreased
5%
Gastrooesophageal reflux disease
4%
Abdominal distension
4%
Dizziness
4%
Blood creatine phosphokinase increased
4%
Nasopharyngitis
4%
Leukopenia
4%
Cancer pain
4%
Stomatitis
4%
Oedema peripheral
4%
Blood creatine phosphokinase MB increased
4%
Blood bilirubin increased
4%
Haemoptysis
4%
White blood cell count decreased
4%
Hypotension
4%
Abdominal pain upper
4%
Pneumonitis
3%
Upper respiratory tract infection
3%
Hyperthyroidism
3%
Hypocalcaemia
3%
Dysphonia
3%
C-reactive protein increased
3%
Hyperkalaemia
3%
Hypoglycaemia
3%
Myalgia
2%
Neutrophil count decreased
2%
Oesophageal obstruction
2%
Upper gastrointestinal haemorrhage
2%
Hypochloraemia
2%
Hyperuricaemia
2%
Thrombocytopenia
1%
Neutropenia
1%
Oesophageal fistula
1%
Pulmonary embolism
1%
Immune-mediated myositis
1%
Pleural effusion
1%
Tumour pain
1%
Peripheral sensory neuropathy
1%
Type 1 diabetes mellitus
1%
Hypercalcaemia
1%
Multiple organ dysfunction syndrome
1%
Oesophagomediastinal fistula
1%
Pneumonia aspiration
1%
Sepsis
1%
Death
1%
General physical health deterioration
1%
Immune-mediated lung disease
1%
Pulmonary haemorrhage
1%
Oesophageal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tislelizumab
Investigator Chosen Chemotherapy (ICC)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tislelizumab (BGB-A317) + chemotherapyExperimental Treatment5 Interventions
Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.
Group II: Placebo + chemotherapyPlacebo Group5 Interventions
Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
Not yet FDA approved
Cisplatin
FDA approved
Capecitabine
FDA approved
Oxaliplatin
FDA approved
5-FU
2014
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
177 Previous Clinical Trials
28,063 Total Patients Enrolled
Jin Wang, MDStudy DirectorBeiGene
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the stomach or esophagus and cannot be surgically removed.I have stomach or junction cancer that is HER2 positive.I am fully active or can carry out light work.My recent tests show my organs are working well.I haven't had systemic therapy for my advanced stomach cancer, but may have had prior therapy if no recurrence in 6 months.I have active cancer spread to the brain or its linings that is not under control.I have previously been treated with drugs targeting immune checkpoints.My stomach cancer is of a specific type (squamous cell, undifferentiated).
Research Study Groups:
This trial has the following groups:- Group 1: Tislelizumab (BGB-A317) + chemotherapy
- Group 2: Placebo + chemotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger