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PD-L1 Inhibitor
Regorafenib + Durvalumab for Liver Cancer
Phase 2
Recruiting
Led By Mehmet Akce
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical staging T1b/T2 or T3 hepatocellular cancer TNM staging American Joint Committee on Cancer (AJCC) International Union Against Cancer (UICC) 8th edition
Body weight > 30 kg
Must not have
Adequately treated carcinoma in situ without evidence of disease
Any chronic skin condition that does not require systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Summary
This trial is testing whether a combination of two drugs can shrink tumors in patients with high-risk liver cancer.
Who is the study for?
Adults with high-risk liver cancer (Hepatocellular Carcinoma) who can swallow pills, have no severe liver issues (Child Pugh class A), and are not pregnant. They should be able to follow the study protocol and haven't had certain treatments for liver cancer or immunotherapies like Durvalumab before.
What is being tested?
The trial is testing a combination of Regorafenib, which blocks enzymes needed for tumor growth, and Durvalumab, an antibody that helps the immune system fight cancer. It aims to see if this combo is better at shrinking tumors in patients with advanced liver cancer.
What are the potential side effects?
Possible side effects include fatigue, diarrhea, high blood pressure from Regorafenib; while Durvalumab may cause immune-related reactions affecting lungs, intestines or skin rash. Liver function might also be affected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer is at an early to mid-stage according to the AJCC 8th edition.
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My body weight is over 30 kg.
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My liver cancer diagnosis is confirmed by tests or clinical criteria.
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I am willing and able to follow the study's treatment and visit schedule.
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I have multiple tumors, with at least one larger than 5 cm.
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My tumor is larger than 2 cm with blood vessel invasion, or I have multiple tumors but none are over 5 cm.
Select...
I am 18 years old or older.
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My tumor is larger than 5 cm and has not invaded blood vessels.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function, measured by creatinine or its clearance, is within the required range.
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My liver functions well despite my illness.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My early-stage cancer was treated successfully with no current signs of it.
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I have a skin condition that doesn't need treatment with pills or injections.
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I do not have any serious ongoing illnesses that could affect my participation in the study.
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My liver cancer is of a specific type (mixed or fibrolamellar).
Select...
I am eligible for a liver transplant.
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My cancer has spread beyond my liver.
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I have previously been treated with specific immune therapies or other approved drugs for liver cancer.
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I have not had major surgery in the last 28 days.
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I have had cancer spread to the lining of my brain and spinal cord.
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I am HIV positive and currently on antiretroviral therapy.
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My thyroid condition is stable with medication.
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I have had cancer before, but it was a different type than my current diagnosis.
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I had skin cancer (not melanoma) treated and currently show no signs of it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (ORR) (unconfirmed)
Secondary study objectives
Incidence of adverse events
Overall survival (OS)
Pathologic complete response
+3 moreSide effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT0202460782%
Diarrhoea
76%
Nausea
71%
Fatigue
57%
Vomiting
53%
Abdominal pain
30%
Neuropathy peripheral
27%
Dyspnoea
25%
Anaemia
23%
Neutrophil count decreased
23%
Constipation
22%
Weight decreased
21%
Hypokalaemia
20%
Oedema peripheral
18%
Dehydration
17%
Cough
17%
Neutropenia
17%
Pyrexia
17%
Peripheral sensory neuropathy
16%
Thrombocytopenia
15%
Platelet count decreased
15%
Back pain
13%
Mucosal inflammation
13%
Temperature intolerance
13%
Dysgeusia
13%
Chromaturia
12%
White blood cell count decreased
12%
Urinary tract infection
11%
Dizziness
11%
Depression
10%
Hyponatraemia
10%
Stomatitis
10%
Ascites
10%
Dysphagia
10%
Anxiety
9%
Headache
9%
Abdominal distension
9%
Insomnia
8%
Arthralgia
8%
Asthenia
8%
Pain in extremity
8%
Alopecia
7%
Urine ketone body present
7%
Blood alkaline phosphatase increased
7%
Pulmonary embolism
6%
Lymphopenia
6%
Leukopenia
6%
Blood bilirubin increased
6%
Dyspepsia
5%
Sepsis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Urine leukocyte esterase positive
5%
Abdominal pain upper
5%
Gastrooesophageal reflux disease
5%
Proteinuria
5%
Rash
4%
Flatulence
4%
Chills
3%
Dry mouth
3%
Myalgia
3%
Epistaxis
3%
Muscle spasms
2%
Pneumonia
2%
pelvic fracture
2%
Haematemesis
2%
Disease progression
2%
Pleural effusion
2%
Confusional state
2%
Mental status changes
2%
malignant neoplasm progression
1%
Large intestine perforation
1%
Oesophagitis
1%
Lung abscess
1%
embolism
1%
pancreatic carcinoma
1%
fall
1%
Death
1%
Haemorrhage intranial
1%
Atrial fibrillation
1%
Colitis
1%
Enterocutaneous fistula
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
somnolence
1%
syncope
1%
Febrile neutropenia
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Hypoxia
1%
Pneumonia aspiration
1%
Clostridium difficile colitis
1%
Influenza
1%
Perirectal abscess
1%
Salmonella sepsis
1%
Septic shock
1%
hip fracture
1%
deep vein thrombosis
1%
haematoma
1%
pelvic venous thrombosis
1%
Cholangitis
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (regorafenib, durvalumab)Experimental Treatment2 Interventions
Patients receive regorafenib PO QD on days 1-21 and durvalumab IV on day 1. Treatment repeats every 28 days for a maximum of 2 years from registration or until decision to proceed to surgery, disease progression, excessive toxicity, or patient withdrawal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3840
Regorafenib
2014
Completed Phase 2
~1600
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
4,971 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,970 Total Patients Enrolled
47 Trials studying Hepatocellular Carcinoma
15,394 Patients Enrolled for Hepatocellular Carcinoma
Mehmet AkcePrincipal InvestigatorAcademic and Community Cancer Research United
2 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My early-stage cancer was treated successfully with no current signs of it.I can take pills by mouth.I haven't had active disease in the last 5 years and have consulted the study doctor.My liver cancer is at an early to mid-stage according to the AJCC 8th edition.My body weight is over 30 kg.I have a skin condition that doesn't need treatment with pills or injections.I have signed the consent form for this trial within the last 28 days.My liver cancer diagnosis is confirmed by tests or clinical criteria.I am willing and able to follow the study's treatment and visit schedule.I do not have any serious ongoing illnesses that could affect my participation in the study.I have multiple tumors, with at least one larger than 5 cm.I have not received a live vaccine in the last 30 days.My blood clotting tests are normal or managed with medication.I am not on any cancer treatments but may be on hormone therapy for other reasons.My liver cancer is of a specific type (mixed or fibrolamellar).I am eligible for a liver transplant.I have nerve damage that affects my daily activities.I have or had an autoimmune or inflammatory disorder.My cancer was treated with the goal of cure, and I've been free of active disease for 3+ years.My tumor is larger than 2 cm with blood vessel invasion, or I have multiple tumors but none are over 5 cm.I am 18 years old or older.My tumor is larger than 5 cm and has not invaded blood vessels.I am fully active or restricted in physically strenuous activity but can do light work.I do not have an active infection like TB, hepatitis B, or hepatitis C.My kidney function, measured by creatinine or its clearance, is within the required range.My cancer has spread beyond my liver.I have previously been treated with specific immune therapies or other approved drugs for liver cancer.I have not had an upper GI bleed in the last 6 months.I have not had liver treatment in the last 28 days.I have a lasting side effect that won't worsen with durvalumab, as confirmed by a study doctor.I have not had major surgery in the last 28 days.I have had cancer spread to the lining of my brain and spinal cord.I haven't taken immunosuppressive drugs in the last 14 days.I am not pregnant or breastfeeding and willing to use birth control during and up to 90 days after treatment.My liver functions well despite my illness.I am HIV positive and currently on antiretroviral therapy.My thyroid condition is stable with medication.I have had cancer before, but it was a different type than my current diagnosis.I had skin cancer (not melanoma) treated and currently show no signs of it.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (regorafenib, durvalumab)
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.
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