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MTL-CEBPA + Sorafenib for Liver Cancer (OUTREACH2 Trial)

Phase 2
Waitlist Available
Research Sponsored by Mina Alpha Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of 0 or 1
Naïve to tyrosine kinase inhibitors, including sorafenib, regorafenib, cabozantinib, and lenvatinib
Must not have
Participants with sepsis, ineffective biliary drainage with or without cholangitis, obstructive jaundice, or encephalopathy at screening visit or within the last 2 weeks prior to study treatment initiation
Participants with no prior therapy who are eligible for first-line treatment with atezolizumab in combination with bevacizumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first cycle of treatment to end of study approximately one year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an experimental treatment (MTL-CEBPA) in combination with a standard of care treatment (sorafenib) in patients with advanced liver cancer (hepatocellular carcinoma) as a result of hepatitis B and/or C infection.

Who is the study for?
This trial is for adults with advanced liver cancer due to hepatitis B/C, who have a life expectancy of over 3 months and are not suitable for surgery or liver transplant. They should be new to tyrosine kinase inhibitors like sorafenib and must have normal organ function tests. Pregnant women, those with severe liver impairment (Child-Pugh B/C), recent serious cardiovascular issues, other active cancers, or known allergies to the drugs tested cannot participate.
What is being tested?
The study compares two approaches: one group receives MTL-CEBPA via IV every three weeks plus oral Sorafenib starting Day 8; the other gets only Sorafenib from Day 1. The goal is to see if adding MTL-CEBPA improves outcomes in hepatocellular carcinoma patients who've had hepatitis B/C.
What are the potential side effects?
Potential side effects include reactions at the infusion site for MTL-CEBPA, as well as common drug-related risks such as fatigue, digestive problems, skin reactions and high blood pressure from Sorafenib. Previous studies suggest that combining these treatments has an acceptable safety profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have not taken any tyrosine kinase inhibitor medications.
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I have advanced liver cancer with cirrhosis, and a history of hepatitis B or C.
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I am not a candidate for liver transplantation.
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I can swallow and keep down pills.
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My liver cancer worsened after treatment with atezolizumab and bevacizumab.
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I am using reliable birth control methods.
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My liver function is good.
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My liver tumor cannot be surgically removed and hasn't responded to targeted treatments.
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My liver cancer is at an advanced stage.
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My kidneys are functioning well enough to filter waste.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had sepsis, issues with bile drainage, jaundice, or brain function problems recently.
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I am eligible for my first cancer treatment with atezolizumab and bevacizumab.
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I have had an organ transplant.
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My liver cancer is of a specific type (fibrolamellar or mixed).
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I have liver-related brain issues not improved with treatment in the last 6 months.
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I have HIV with low CD4+ T-cell counts or a history of severe infections.
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My cancer has spread to my brain or spinal cord.
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I have another cancer that has been active or treated in the last 5 years.
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I have an immune system disorder or I am on long-term steroids.
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I have never had hepatitis B or C.
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My liver disease is moderately to severely advanced.
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I have had bleeding or a tear in my stomach or intestines.
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I have had spontaneous bacterial peritonitis, renal failure, or an allergic reaction recently.
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I have a significant buildup of fluid in my abdomen.
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I am not allergic to MTL-CEBPA or sorafenib or their ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first cycle of treatment to end of study approximately one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first cycle of treatment to end of study approximately one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival (PFS)
Secondary study objectives
Adverse events
Health-related quality of life (HRQoL) questionnaires
Overall survival (OS)

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Blurred vision
2%
Hypothyroidism
2%
Urticaria
2%
Hemorrhoids
2%
Acute kidney injury
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MTL-CEBPA in combination with sorafenibExperimental Treatment2 Interventions
Intravenous infusion of MTL-CEBPA 130mg/m2 given once every 3 weeks. Oral sorafenib 400mg twice a day will commence C1D8.
Group II: Sorafenib aloneActive Control1 Intervention
Oral sorafenib 400mg twice a day commencing Day1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib
2014
Completed Phase 3
~1670

Find a Location

Who is running the clinical trial?

Mina Alpha LimitedLead Sponsor
2 Previous Clinical Trials
183 Total Patients Enrolled

Media Library

MTL-CEBPA (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04710641 — Phase 2
Hepatitis C Research Study Groups: MTL-CEBPA in combination with sorafenib, Sorafenib alone
Hepatitis C Clinical Trial 2023: MTL-CEBPA Highlights & Side Effects. Trial Name: NCT04710641 — Phase 2
MTL-CEBPA (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04710641 — Phase 2
~0 spots leftby Dec 2024
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