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Fluoropyrimidine
Tislelizumab + Chemotherapy for Esophageal 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
Pathologically (histologically) confirmed diagnosis of ESCC
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years and 2 months (as of primary analysis data cut-off date of 28feb2022)
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is effective and safe for people with a certain type of esophageal cancer.
Who is the study for?
This trial is for adults with advanced esophageal squamous cell carcinoma that can't be removed by surgery. They should have a confirmed diagnosis, and if they've had platinum-based chemo before, it must be at least 6 months ago. People with significant recent weight loss, poor nutrition status, active hepatitis B or C, previous PD-1/PD-L1/PD-L2 treatments, or those needing frequent fluid drainage from the body are excluded.Check my eligibility
What is being tested?
The study tests Tislelizumab combined with chemotherapy (Paclitaxel/Cisplatin/Oxaliplatin/Capecitabine/5-FU) as a first treatment option for patients with advanced esophageal cancer. It aims to see how effective and safe this combination is compared to standard treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells (infusion reactions), fatigue, nausea and vomiting from chemotherapy drugs used in the trial. There may also be an increased risk of infections due to lowered immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed to be esophageal squamous cell carcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years and 2 months (as of primary analysis data cut-off date of 28feb2022)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years and 2 months (as of primary analysis data cut-off date of 28feb2022)
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
Duration of Response (DOR)
Health-Related Quality of Life (HRQoL) Assessment of the Participant's Overall Health Status Using European Quality of Life-Core 30 Questionnaire Index (EORTC QLQ-C30)
Health-Related Quality of Life (HRQoL) Assessment of the Participant's Overall Health Status Using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Esophageal Cancer Specific Module (EORTC QLQ-OES18)
+5 moreOther outcome measures
Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30)
Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18)
Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the generic health state instrument European Quality of Life-5 Dimensions (EuroQol 5D EQ-5D-5L)
+2 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%
Hypokalaemia
9%
Rash
8%
Insomnia
7%
Hyperglycaemia
7%
Abdominal pain
7%
Blood alkaline phosphatase increased
7%
Productive cough
6%
Malaise
5%
Hypertension
5%
Hypoproteinaemia
5%
White blood cell count increased
5%
Gastrooesophageal reflux disease
5%
Gamma-glutamyltransferase increased
5%
Lymphocyte count decreased
5%
Platelet count decreased
4%
Abdominal pain upper
4%
Cancer pain
4%
Leukopenia
4%
Hypotension
4%
Stomatitis
4%
Blood creatine phosphokinase increased
4%
Oedema peripheral
4%
Blood creatine phosphokinase MB increased
4%
Nasopharyngitis
4%
Haemoptysis
4%
Abdominal distension
4%
Dizziness
4%
Blood bilirubin increased
4%
White blood cell count decreased
4%
Pneumonitis
3%
Hypocalcaemia
3%
Myalgia
3%
Hypoglycaemia
3%
Dysphonia
3%
Upper respiratory tract infection
3%
Hyperthyroidism
3%
C-reactive protein increased
3%
Hyperkalaemia
2%
Upper gastrointestinal haemorrhage
2%
Oesophageal obstruction
2%
Neutrophil count decreased
2%
Hyperuricaemia
2%
Hypochloraemia
2%
Thrombocytopenia
1%
Oesophageal fistula
1%
General physical health deterioration
1%
Tumour pain
1%
Peripheral sensory neuropathy
1%
Sepsis
1%
Pleural effusion
1%
Multiple organ dysfunction syndrome
1%
Oesophageal stenosis
1%
Oesophagomediastinal fistula
1%
Hypercalcaemia
1%
Pneumonia aspiration
1%
Type 1 diabetes mellitus
1%
Immune-mediated myositis
1%
Immune-mediated lung disease
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Neutropenia
1%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tislelizumab
Investigator Chosen Chemotherapy (ICC)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tislelizumab + ChemotherapyExperimental Treatment6 Interventions
Tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each cycle every 3 weeks (Q3W) plus one of the following until unacceptable toxicity, disease progression or withdrawal for other reasons; each cycle is 21 days
Chemotherapy Doublet A: cisplatin 60-80 mg/m^2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and 5-fluorouracil IV 750-800 mg/m^2 on Days 1 to 5 of each cycle Q3W;
Chemotherapy Doublet B: cisplatin 60-80 mg/m^2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and capecitabine orally 1000 mg/m^2 on Days 1 to 14 of each cycle, twice a day; or
Chemotherapy Doublet C: cisplatin 60-80 mg/m^2 administered IV on Day 1 or 2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and paclitaxel 175 mg/m^2 IV on Day 1 of each cycle Q3W; cisplatin may be given in 3 divided doses on Days 1, 2, and 3 depending on local guidelines
Group II: Placebo + ChemotherapyActive Control6 Interventions
Matched placebo administered IV on Day 1 of each cycle every 3 weeks (Q3W) plus one of the following until unacceptable toxicity, disease progression or withdrawal for other reasons; each cycle is 21 days
Chemotherapy Doublet A: cisplatin 60-80 mg/m^2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and 5-fluorouracil IV 750-800 mg/m^2 on Days 1 to 5 of each cycle Q3W;
Chemotherapy Doublet B: cisplatin 60-80 mg/m^2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and capecitabine orally 1000 mg/m^2 on Days 1 to 14 of each cycle, twice a day; or
Chemotherapy Doublet C: cisplatin 60-80 mg/m^2 administered IV on Day 1 or 2 or oxaliplatin 130 mg/m^2 administered IV on Day 1 of each cycle Q3W and paclitaxel 175 mg/m^2 IV on Day 1 of each cycle Q3W; cisplatin may be given in 3 divided doses on Days 1, 2, and 3 depending on local guidelines
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Cisplatin
2013
Completed Phase 3
~1940
Oxaliplatin
2011
Completed Phase 4
~2560
Capecitabine
2013
Completed Phase 3
~3420
Tislelizumab
2018
Completed Phase 3
~4260
Fluorouracil (5-FU)
2014
Completed Phase 2
~300
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,165 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,207 Previous Clinical Trials
489,031 Total Patients Enrolled
Sumei Liu, MDStudy DirectorBeiGene
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My esophageal cancer is advanced and cannot be removed by surgery, and if I had prior therapy, it was over 6 months ago.I have lost more than 5% of my weight in the last month or my nutrition levels are very low.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I frequently need treatment for fluid buildup in my chest or abdomen.I have a fistula connecting my esophagus to my bronchus or aorta.My esophageal cancer can potentially be removed or cured with radiation.I have had treatment for advanced esophageal cancer that cannot be surgically removed.I have chronic hepatitis B with high viral load or active hepatitis C.My cancer is confirmed to be esophageal squamous cell carcinoma.I have received palliative radiation for esophageal cancer within the last 4 weeks.My esophagus is completely blocked and cannot be treated.
Research Study Groups:
This trial has the following groups:- Group 1: Tislelizumab + Chemotherapy
- Group 2: Placebo + Chemotherapy
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are some of the conditions that Tislelizumab has been known to improve?
"Tislelizumab is most commonly used to treat neoplasm metastasis, but it can also be applied to patients with colorectal carcinoma, malignant neoplasm of the pancreas, and duke's c colon cancer."
Answered by AI
How does Tislelizumab's safety profile look to researchers?
"Tislelizumab's safety is classified as a 3 due to the fact that it has progressed to Phase III trials. This signifies that, not only does this medication show some efficacy, but there is also multiple data sets affirming its safety."
Answered by AI
Can you tell me how many different hospitals are testing this new treatment?
"This trial is being conducted at Allegheny General Hospital (AGH) in Pittsburgh, Smilow Cancer Hospital at Yale-New Haven - Neurology in New Haven, and Medical University of South carolina Hollings Cancer Center in Charleston. There are also 6 other enrolling locations."
Answered by AI
How many research subjects are you testing this on?
"As of right now, this particular trial is not taking any more patients. The study was first posted on December 11th, 2018 and the most recent update was on April 26th, 2022. However, there are still active clinical trials recruiting patients with esophageal squamous cell carcinoma (2682 studies) and Tislelizumab (2002 studies)."
Answered by AI
Can you tell us about other times Tislelizumab has been used in medical research?
"Tislelizumab was first researched in 1997 at the City of Hope Comprehensive Cancer Center. To date, a total of 21142 clinical trials have been completed while 2002 studies are still recruiting patients. A large number of these active trials are based in Pittsburgh, Pennsylvania."
Answered by AI
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