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%
Decreased appetite
16%
Constipation
16%
Pyrexia
15%
Aspartate aminotransferase increased
15%
Nausea
14%
Hypoalbuminaemia
13%
Fatigue
13%
Alanine aminotransferase increased
13%
Diarrhoea
12%
Hypothyroidism
12%
Hyponatraemia
11%
Asthenia
11%
Vomiting
11%
Pneumonia
11%
Back pain
10%
Pruritus
10%
Dyspnoea
9%
Dysphagia
9%
Arthralgia
9%
Rash
9%
Hypokalaemia
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%
Gastrooesophageal reflux disease
5%
Gamma-glutamyltransferase increased
5%
Hypertension
5%
Lymphocyte count decreased
5%
Platelet count decreased
4%
Dizziness
4%
Nasopharyngitis
4%
Leukopenia
4%
Stomatitis
4%
Oedema peripheral
4%
Blood creatine phosphokinase MB increased
4%
Cancer pain
4%
Haemoptysis
4%
Blood creatine phosphokinase increased
4%
Abdominal distension
4%
Blood bilirubin increased
4%
White blood cell count decreased
4%
Hypotension
4%
Abdominal pain upper
4%
Pneumonitis
3%
Upper respiratory tract infection
3%
Myalgia
3%
Hyperthyroidism
3%
Hypocalcaemia
3%
Hypoglycaemia
3%
Dysphonia
3%
C-reactive protein increased
3%
Hyperkalaemia
2%
Neutrophil count decreased
2%
Oesophageal obstruction
2%
Upper gastrointestinal haemorrhage
2%
Hyperuricaemia
2%
Hypochloraemia
2%
Thrombocytopenia
1%
Immune-mediated lung disease
1%
Pulmonary embolism
1%
General physical health deterioration
1%
Oesophageal fistula
1%
Peripheral sensory neuropathy
1%
Immune-mediated myositis
1%
Type 1 diabetes mellitus
1%
Pleural effusion
1%
Hypercalcaemia
1%
Multiple organ dysfunction syndrome
1%
Oesophagomediastinal fistula
1%
Oesophageal stenosis
1%
Pneumonia aspiration
1%
Neutropenia
1%
Sepsis
1%
Pulmonary haemorrhage
1%
Death
1%
Tumour pain
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
175 Previous Clinical Trials
27,828 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Tislelizumab likely to cause any negative side effects in patients?
"Tislelizumab's safety is estimated to be a 3. This assessment comes from the fact that Tislelizumab is in Phase 3 of clinical trials. At this stage, there is already some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
What are the most common benefits of Tislelizumab?
"Tislelizumab is not just effective against refractory fallopian tube carcinoma, but also advanced ovarian cancer, metastatic colorectal carcinoma, and pancreatic endocrine carcinoma."
Answered by AI
Where are patients being asked to participate in this experiment?
"There are 7 locations available for this study, which include Reading Hospital in West Reading, Fox Chase Cancer Center in Philadelphia, and University of California Davis Health System in Sacramento."
Answered by AI
What do we know about Tislelizumab from other research?
"As of right now, there are a whopping 1326 different clinical trials underway that involve Tislelizumab. That being said, 461 of those studies are still in Phase 3. The majority of these research programs are based out of Guangzhou, Guangdong; however, there are 61814 locations worldwide where Tislelizumab is being trialed as a potential treatment option."
Answered by AI
Are there any spots left for new participants in this scientific experiment?
"No, the trial is not currently recruiting patients. The last update on clinicaltrials.gov was on August 25th, 2022 and indicated that the study is not presently looking for new candidates. There are 2309 other trials you may be eligible for."
Answered by AI
Who else is applying?
What site did they apply to?
Ohio State University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger