Your session is about to expire
← Back to Search
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My liver cancer is at an advanced stage and cannot be treated with local therapies.
Select...
My cancer progressed or I couldn't tolerate the first treatment with immune checkpoint inhibitors.
Select...
I have advanced liver cancer not suitable for surgery or local treatments, or it has worsened after such treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Objective Response Rate (ORR) (confirmed) as evaluated by an Independent Review Committee (IRC) according to RECIST v1.1
Secondary outcome measures
DCR as evaluated by an IRC according to HCC mRECIST
DCR as evaluated by the investigator according to HCC mRECIST
DCR as evaluated by the investigator according to RECIST v1.1
+23 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Suzhou Kintor Pharmaceutical Inc,Lead Sponsor
14 Previous Clinical Trials
2,838 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received immune therapy less than 4 weeks ago.My liver function is good, with a Child-Pugh score of 6 or less.I have another cancer that is getting worse or was treated in the last 3 years.My liver cancer is at an advanced stage and cannot be treated with local therapies.I have or had cancer spread to my brain or spinal cord.My cancer progressed or I couldn't tolerate the first treatment with immune checkpoint inhibitors.I've had a liver-targeted therapy within the last 4 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I have an active tuberculosis infection.I haven't had blood clots or strokes in the last 6 months, or if I have, I've been on a stable blood thinner for 2 weeks.I have an active hepatitis B and/or C infection, or hepatitis D with hepatitis B.I have a serious wound, ulcer, or untreated bone fracture that is not healing.I have had encephalopathy in the past.I have had an organ or bone marrow transplant.My blood tests and organ functions are normal.I have had pneumonitis treated with steroids or have it now.I have received TKI treatment before starting this study.I have had bleeding from varices in my esophagus or stomach in the last 6 months.I have advanced liver cancer not suitable for surgery or local treatments, or it has worsened after such treatments.I have received Nivolumab as my first treatment.My liver cancer has spread to major blood vessels or the heart.I have not had a serious infection needing treatment in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: GT90001+Nivolumab
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.
Has GT90001 received official authorization from the FDA?
"The safety of GT90001 is rated as a 2, since it has been tested in Phase 2 trials and there is only some evidence to support its security, while no data exists on its efficacy."
Answered by AI
What indications are GT90001 administered for?
"GT90001 is primarily utilized in the treatment of malignant neoplasms, but its therapeutic potential extends beyond this to include unresectable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinama."
Answered by AI
Is this research endeavor presently open to participants?
"According to the latest information from clinicaltrials.gov, this experiment is enrolling participants as of April 30th 2022. The study was initially made available on August 1st 2021."
Answered by AI
Could you provide an estimate of the total number of individuals enrolled in this trial?
"Affirmative. According to records on clinicaltrials.gov, this study is at present searching for individuals to participate in the trial that was first posted on August 1st 2021 and recently amended April 30th 2022. A total of 105 people are needed from two different locations."
Answered by AI
Is this the inaugural research of its kind?
"The development of GT90001 was initiated in 2012 when Ono Pharmaceutical Co. Ltd sponsored the first trial with 659 participants. The successful conclusion of Phase 1 & 2 trials granted drug approval, and since then there have been 718 live studies conducted across 2356 cities located in 49 countries worldwide."
Answered by AI
Have there been any antecedent experiments involving GT90001?
"Presently, there are 718 clinical trials focusing on GT90001. Of these active studies, 82 have reached Phase 3 status. Primarily based in Basel, BE , this treatment is being tested at 40285 sites throughout the world."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger