← Back to Search

Kinase Inhibitor

Tislelizumab for Liver 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 from date of enrollment up to 4 years, approximately
Awards & highlights

Study Summary

This trial will compare the effectiveness of two different drugs for people with liver cancer that cannot be removed by surgery. The trial will also look at the safety and how well the drugs are tolerated in Japanese participants.

Eligible Conditions
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization up 4 years, approximately
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization up 4 years, approximately 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)
Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of tislelizumab
Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of Tislelizumab
+8 more
Secondary outcome measures
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+14 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%
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%
White blood cell count increased
5%
Hypoproteinaemia
5%
Gastrooesophageal reflux disease
5%
Gamma-glutamyltransferase increased
5%
Lymphocyte count decreased
5%
Platelet count decreased
4%
Nasopharyngitis
4%
Abdominal pain upper
4%
Leukopenia
4%
Hypotension
4%
Stomatitis
4%
Oedema peripheral
4%
Blood creatine phosphokinase MB increased
4%
Haemoptysis
4%
Blood creatine phosphokinase increased
4%
Cancer pain
4%
Abdominal distension
4%
Dizziness
4%
Blood bilirubin increased
4%
White blood cell count decreased
4%
Pneumonitis
3%
Myalgia
3%
Hypocalcaemia
3%
Hypoglycaemia
3%
Dysphonia
3%
Upper respiratory tract infection
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%
Pleural effusion
1%
Multiple organ dysfunction syndrome
1%
Oesophagomediastinal fistula
1%
Hypercalcaemia
1%
Oesophageal stenosis
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: Arm A: Tislelizumab & Safety Run-In Substudy [Japan Only]Experimental Treatment1 Intervention
Group II: Arm B: SorafenibActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
175 Previous Clinical Trials
28,140 Total Patients Enrolled
Yaxi Chen, MDStudy DirectorBeiGene

Media Library

Sorafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03412773 — Phase 3
Liver Cancer Research Study Groups: Arm B: Sorafenib, Arm A: Tislelizumab & Safety Run-In Substudy [Japan Only]
Liver Cancer Clinical Trial 2023: Sorafenib Highlights & Side Effects. Trial Name: NCT03412773 — Phase 3
Sorafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03412773 — Phase 3

Frequently Asked Questions

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

How many sites are involved in the implementation of this trial?

"This clinical trial is presently enlisting participants from 19 sites, distributed amongst Orange, Lake Success and Nashville as well as other cities. To lessen your commuting costs if you decide to join the experiment, it is essential to pick the closest site available."

Answered by AI

Are there any analogous experiments involving Tislelizumab?

"Initially tested in 2005 at Central Illinois Hematology Oncology Center, tislelizumab has seen 407 trials to date. Of the 165 active studies today, many are hosted out of Orange, California."

Answered by AI

Is there currently an opportunity to join this research experiment?

"The clinicaltrials.gov database states that this trial, which was initially posted on December 28th 2017 and last updated on December 7th 2022, is no longer actively recruiting patients. However, there are still 2782 other studies currently searching for volunteers to participate in the research."

Answered by AI

What types of illnesses can Tislelizumab be utilized to combat?

"Tislelizumab is used to combat the proliferation of radioactive iodine-refractory differentiated thyroid carcinoma (dtc) as well as gastrointestinal stromal tumors, hemangiosarcoma and leiomyosarcoma."

Answered by AI

What is the current enrollment rate for this trial?

"At this time, enrollment for the trial has been suspended. According to records on clinicaltrials.gov, it was first made available in December 2017 and last modified in December 2022. If you are seeking alternate studies, there are currently 2617 trials involving carcinoma hepatocellular actively recruiting participants as well as 165 research initiatives concerning tislelizumab that have open admissions."

Answered by AI

What potential risks have been associated with Tislelizumab use?

"Our team at Power has assigned a score of 3 to tislelizumab, indicating that there is both existing data confirming its efficacy and extensive safety research."

Answered by AI
~92 spots leftby Apr 2025