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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

No Placebo-Only Group

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 below

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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.

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I am 18 years old or older.

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My tumor is larger than 5 cm and has not invaded blood vessels.

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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:

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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).

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Objective response rate (ORR) (unconfirmed)

Secondary study objectives

Incidence of adverse events

Overall survival (OS)

Pathologic complete response

+3 more

Side effects data

From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607

82%

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

Headache

Abdominal distension

Insomnia

Arthralgia

Asthenia

Pain in extremity

Alopecia

Urine ketone body present

Blood alkaline phosphatase increased

Pulmonary embolism

Lymphopenia

Leukopenia

Blood bilirubin increased

Dyspepsia

Sepsis

Palmar-plantar erythrodysaesthesia syndrome

Hypertension

Urine leukocyte esterase positive

Abdominal pain upper

Gastrooesophageal reflux disease

Proteinuria

Rash

Flatulence

Chills

Dry mouth

Myalgia

Epistaxis

Muscle spasms

Pneumonia

pelvic fracture

Haematemesis

Disease progression

Pleural effusion

Confusional state

Mental status changes

malignant neoplasm progression

Large intestine perforation

Oesophagitis

Lung abscess

embolism

pancreatic carcinoma

fall

Death

Haemorrhage intranial

Atrial fibrillation

Colitis

Enterocutaneous fistula

Gastrointestinal haemorrhage

Upper gastrointestinal haemorrhage

Chest pain

somnolence

syncope

Febrile neutropenia

Acute kidney injury

Acute respiratory failure

Hypoxia

Pneumonia aspiration

Clostridium difficile colitis

Influenza

Perirectal abscess

Salmonella sepsis

Septic shock

hip fracture

deep vein thrombosis

haematoma

pelvic venous thrombosis

Cholangitis

Ischaemic cerebral infarction

Hyperglycaemia

subdural haematoma

100%

80%

60%

40%

20%

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

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: 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

~3750

Regorafenib

2014

Completed Phase 2

~1600