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Tislelizumab for Liver Cancer
Phase 2
Recruiting
Led By Salma Jabbour, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Demonstrate adequate bone marrow and organ function as defined below: Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin > 8.5 g/dL, Platelet count ≥ 75,000/mcL; Renal - Serum creatinine OR calculated* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels > 1.5x institutional ULN; Urine protein Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment *Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours; Hepatic - Serum total bilirubin ≤ 3 mg/dL, AST (SGOT) and ALT (SGPT) ≤ 5x ULN, Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN *This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study Summary
This trial will test if adding the drug Tislelizumab to standard treatment for inoperable HCC will improve one year progression-free survival rates and control of the disease.
Who is the study for?
This trial is for adults with advanced inoperable liver cancer (HCC) who haven't had systemic therapy but may have had TACE. They should be treatment-ready, without severe liver impairment (Child-Pugh A or B7), and no spread of cancer outside the liver. Participants need good organ function, manageable pain levels, a life expectancy over six months, and must agree to use effective birth control.Check my eligibility
What is being tested?
The study tests if Tislelizumab can improve survival rates when given after local treatments like radiation for HCC. It aims to see if this drug helps control the disease locally and fights off tiny undetected spreads of cancer.See study design
What are the potential side effects?
Tislelizumab might cause immune-related side effects such as inflammation in various organs, potential skin reactions, fatigue, possible hormonal imbalances due to thyroid issues or diabetes management changes if applicable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have liver cancer, haven't had systemic treatment but may have had TACE.
Select...
I am able to get out of my bed or chair and move around.
Select...
My liver cancer diagnosis was confirmed by specific tests or imaging.
Select...
My liver is functioning well enough, but I can't have liver surgery or a transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety as assessed by number of participants experiencing adverse events
Secondary outcome measures
Response and progression will be evaluated in this trial using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee (v1.1).
Side 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%
Arthralgia
9%
Dysphagia
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%
Abdominal pain upper
4%
Nasopharyngitis
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%
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%
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
1Treatment groups
Experimental Treatment
Group I: Tislelizumab in conjunction with radiation therapyExperimental Treatment1 Intervention
Participants will receive local therapy including TACE+ RT or Ablation (tumors with incomplete ablation) + RT or RT alone (for patients not eligible for TACE or Ablation) and will be screened for eligibility prior to enrollment.
Once eligibility has been confirmed, Tislelizumab will be started before radiation therapy and will continue after radiation therapy.
Participants who do not receive Tislelizumab for a total of two cycles will be replaced and interpreted for only toxicity analysis.
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?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,197 Total Patients Enrolled
3 Trials studying Liver Cancer
106 Patients Enrolled for Liver Cancer
BioGene Pharmaceutical Ltd.Industry Sponsor
1 Previous Clinical Trials
Natera, Inc.Industry Sponsor
47 Previous Clinical Trials
42,332 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had recent serious heart or stroke issues.I have a skin condition like eczema or psoriasis, but it affects less than 10% of my body and is well-controlled with mild creams.I am 18 years old or older.My cancer has spread to my stomach or intestines.I have liver cancer, haven't had systemic treatment but may have had TACE.I have not had major surgery within the last 28 days.I have not taken any herbal cancer treatments in the last 14 days.I have had Yttrium therapy for liver cancer.My liver cancer affects the main bile ducts.I have had an organ or bone marrow transplant, except a kidney transplant which can be treated with dialysis if rejected.I've had radiation to my liver that might risk harming healthy tissue if repeated.I am able to get out of my bed or chair and move around.I need a procedure to manage fluid buildup in my abdomen.My cancer has spread outside the liver with tumors larger than 3.0 cm in total.I am not currently fighting a severe infection requiring strong antibiotics or antivirals.My liver cancer diagnosis was confirmed by specific tests or imaging.I haven't had severe infections or been hospitalized for them in the last 4 weeks.I have received immunotherapy before.My liver cancer has spread to more than five areas or is affecting my portal vein.I have had a liver transplant.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.My diabetes is not under control, or I have significant blood mineral imbalances.I have an immune system disorder that needs ongoing treatment.I agree to use effective birth control and not donate sperm while on tislelizumab and for 6 months after.I have hepatitis B with a low viral load and am on treatment, but I don't have hepatitis C.My liver is functioning well enough, but I can't have liver surgery or a transplant.I have autoimmune hypothyroidism and am on a stable thyroid medication.I have a history of lung conditions like fibrosis or pneumonitis.I have taken antibiotics by mouth or IV within the last two weeks.I have Type 1 diabetes managed with a stable insulin routine.I haven't had any cancer other than the one being studied or curable skin/bladder/cervix/breast cancer in the last 5 years.I have not received any live vaccines in the last 4 weeks, except for flu and COVID-19 shots.My side effects from previous cancer treatments have mostly gone away or stabilized, except for things like hair loss or numbness.I am willing to use effective birth control during and for 6 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Tislelizumab in conjunction with radiation therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are recruitment efforts still underway for this experiment?
"Per the information on clinicaltrials.gov, this trial is actively recruiting participants as of 9/27/2022 - an update from its initial posting on 7/25/2022."
Answered by AI
How many participants have opted to join this research project?
"Affirmative, the information on clinicaltrials.gov signals that this study is currently enlisting participants. The trial was first published on July 25th 2022 and revised recently in September 27th 2022. It requires 35 individuals to be recruited from two individual sites."
Answered by AI
Has Tislelizumab gained regulatory acceptance from the Food and Drug Administration?
"Our team assigned a moderate safety rating of 2 to Tislelizumab, as there is some evidence suggesting its security but no clinical data confirming efficacy."
Answered by AI
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