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Virus Therapy

GT90001 + Nivolumab for Liver Cancer

Phase 2
Waitlist Available
Research Sponsored by Suzhou Kintor Pharmaceutical Inc,
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy
Have documented disease progression after or intolerance to first line treatment of immune checkpoint inhibitors(ICI)
Must not have
Has received prior immune checkpoint inhibitors within 4 weeks of start of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination therapy for people with liver cancer who have not responded well to other treatments. The proposed dose is GT90001 7 mg/kg in combination with Nivolumab 240 mg, given as an infusion every two weeks. A total of 105 subjects will be enrolled in the study.

Who is the study for?
This trial is for adults with advanced liver cancer (aHCC) who can't have or didn't improve with first-line immune treatments. They should be in relatively good health (Child-Pugh A, ECOG 0-1), not have had certain other cancers recently, no serious infections or organ transplants, and a life expectancy over 3 months.
What is being tested?
The study tests GT90001 combined with Nivolumab in patients whose liver cancer has worsened after or couldn’t tolerate initial immune checkpoint inhibitors. It's an open-label phase II trial where both drugs are given by infusion every two weeks to a total of 105 participants.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, fatigue, possible organ inflammation due to immune response, increased risk of infection and possibly others as seen with similar therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver cancer is at an advanced stage and cannot be treated with local therapies.
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My cancer progressed or I couldn't tolerate the first treatment with immune checkpoint inhibitors.
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I have advanced liver cancer not suitable for surgery or local treatments, or it has worsened after such treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I received immune therapy less than 4 weeks ago.
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I have another cancer that is getting worse or was treated in the last 3 years.
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I have or had cancer spread to my brain or spinal cord.
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I have an active tuberculosis infection.
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I have an active hepatitis B and/or C infection, or hepatitis D with hepatitis B.
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I have a serious wound, ulcer, or untreated bone fracture that is not healing.
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I have had encephalopathy in the past.
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I have had an organ or bone marrow transplant.
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I have had pneumonitis treated with steroids or have it now.
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I have received TKI treatment before starting this study.
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I have had bleeding from varices in my esophagus or stomach in the last 6 months.
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I have received Nivolumab as my first treatment.
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My liver cancer has spread to major blood vessels or the heart.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Objective Response Rate (ORR) (confirmed) as evaluated by an Independent Review Committee (IRC) according to RECIST v1.1

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GT90001+NivolumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Suzhou Kintor Pharmaceutical Inc,Lead Sponsor
17 Previous Clinical Trials
3,866 Total Patients Enrolled

Media Library

GT90001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05178043 — Phase 2
Hepatocellular Carcinoma Research Study Groups: GT90001+Nivolumab
Hepatocellular Carcinoma Clinical Trial 2023: GT90001 Highlights & Side Effects. Trial Name: NCT05178043 — Phase 2
GT90001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05178043 — Phase 2
~0 spots leftby Apr 2025
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