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Monoclonal Antibodies

Tislelizumab 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through end-of-trial analysis data cutoff date of 28-dec-2022 (up to approximately 5 years)
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.

Eligible Conditions
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through end-of-trial analysis data cutoff date of 28-dec-2022 (up to approximately 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through end-of-trial analysis data cutoff date of 28-dec-2022 (up to approximately 5 years) for reporting.

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) in the Intent-to-Treat (ITT) Analysis Set
Secondary outcome measures
Duration of Response (DOR) in the ITT Analysis Set
Duration of Response (DOR) in the PDL-1 Positive Analysis Set.
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set
+11 more

Side effects data

From 2022 Phase 3 trial • 512 Patients • NCT03430843
31%
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%
Arthralgia
9%
Dysphagia
9%
Hypokalaemia
9%
Rash
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%
Abdominal pain upper
4%
Nasopharyngitis
4%
Leukopenia
4%
Hypotension
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%
Dizziness
4%
Blood bilirubin increased
4%
White blood cell count decreased
4%
Pneumonitis
3%
Myalgia
3%
Upper respiratory tract infection
3%
Hypocalcaemia
3%
Hypoglycaemia
3%
Dysphonia
3%
Hyperthyroidism
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%
Oesophageal fistula
1%
General physical health deterioration
1%
Peripheral sensory neuropathy
1%
Tumour pain
1%
Sepsis
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%
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: TislelizumabExperimental Treatment1 Intervention
Tislelizumab on Day 1, given every 21 days
Group II: Investigator chosen chemotherapy (ICC)Active Control3 Interventions
Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
175 Previous Clinical Trials
28,302 Total Patients Enrolled
Virginia Paton, Pharm.D.Study DirectorBeiGene

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What customary applications does Tislelizumab have?

"Patients with malignant peritoneal neoplasms, head tumours and metastatic cancers can benefit from Tislelizumab therapy."

Answered by AI

Has Tislelizumab been granted clearance from the FDA?

"Extensive evidence exists to support the safety of Tislelizumab, thus earning it a 3 on our team's scale. This Phase 3 trial has generated many studies that prove its efficacy and reinforce its security profile."

Answered by AI

How many participants are receiving care in this experiment?

"This trial has concluded its recruitment efforts, having been first posted on January 26th 2018 and most recently updated November 21st 2022. Alternatively, there are 2607 clinical trials recruiting for carcinoma squamous cell patients and 1396 studies involving Tislelizumab."

Answered by AI

Is this experimental endeavor still recruiting participants?

"According to data hosted on clinicaltrials.gov, recruitment for this medical trial has concluded and no longer needs participants; the study first being posted on January 26th 2018 and last edited November 21st 2022. Despite this particular investigation not looking for volunteers currently, there are 4,003 other trials across North America actively searching right now."

Answered by AI

Has the efficacy of Tislelizumab been tested in earlier research studies?

"Currently, there are 1,396 clinical trials assessing the efficacy of Tislelizumab. However, only 376 of those studies have reached Phase 3. While Shanghai is a major hub for these types of experiments, 67844 other locations across the world offer Tislelizumab treatments."

Answered by AI

How many locations are participating in the implementation of this research endeavor?

"Seven medical sites are participating in this experimental study, with prominent centres including Henry Ford Hospital (Detroit), San Antonio Military Medical Center (Fort Sam Houston) and St. Joseph Heritage Healthcare (Fullerton)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
2018. "A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03430843.
~71 spots leftby Apr 2025
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