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Checkpoint Inhibitor

Radiotherapy + Immunotherapy for Liver Cancer

Phase 2

Recruiting

Research Sponsored by Mary Feng, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Appropriate antiviral therapy for hepatitis B virus (HBV) with HBV DNA PCR < 2000 IU/mL

Age >=18 years, life expectancy of >= 12 weeks, body weight > 30 kg

Must not have

Prior treatment with CTLA-4 or PD-L1 inhibitor, history of allogenic organ transplantation

Prior radiotherapy to tumor sites compromising safety of additional treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a combination of immunotherapy drugs and radiation therapy is more effective than radiation therapy alone in treating patients with liver cancer.

Who is the study for?

This trial is for adults with advanced liver cancer that has worsened after PD-1 inhibitor therapy. They must have manageable hepatitis B, good organ function, no history of certain autoimmune diseases or immunodeficiencies, and not be on conflicting medications or treatments. Participants need to agree to use contraception and have a life expectancy of at least 12 weeks.

What is being tested?

The study tests if hypofractionated radiation followed by durvalumab alone or with tremelimumab improves outcomes in liver cancer patients who've progressed on PD-1 inhibitors. It's seeing whether these drugs can boost the immune system's response against cancer when given after targeted high-dose radiation therapy.

What are the potential side effects?

Possible side effects include immune-related inflammation in various organs, infusion reactions from the drug administration, fatigue, digestive issues like diarrhea, potential worsening of pre-existing autoimmune conditions, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on antiviral therapy for hepatitis B with low viral load.

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I am over 18, expected to live more than 12 weeks, and weigh more than 30 kg.

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My blood counts and organ functions are within the required ranges.

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My liver cancer has worsened despite previous immunotherapy, excluding durvalumab.

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I need radiation therapy for my condition.

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I have no known allergies or adverse reactions to immunotherapy or radiation therapy.

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I have at least one tumor that can be measured and hasn't been treated with radiation or local therapy.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with CTLA-4 or PD-L1 inhibitors, or have had an organ transplant.

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I've had radiation that now makes further treatment unsafe.

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I have not had radiation on over 30% of my bone marrow in the last 4 weeks.

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I do not have autoimmune diseases, uncontrolled illnesses, or a history of other cancers.

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I have had severe side effects from previous immunotherapy that have not gone away.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months 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)

Secondary study objectives

Duration of overall response (DOR)

Number of of treatment-related adverse events

Overall survival (OS)

+1 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

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

Group I: Arm II (hypofractionated RT, durvalumab, tremelimumab)Experimental Treatment3 Interventions

Patients undergo standard of care hypofractionated RT over 5 fractions QD for 5 days in the absence of disease progression or unacceptable toxicity. Within 3-10 days after completion of RT, patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1. Treatment with durvalumab repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who complete the first dose of tremelimumab and demonstrate clinical benefit based upon radiographic tumor regression and/or other clinical response without progression for at least 6 cycles or 6 months on treatment, whichever is shorter, and subsequently have evidence of progressive disease during the durvalumab monotherapy portion may receive a repeat dose of tremelimumab at the next scheduled cycle of treatment with durvalumab per physician discretion.

Group II: Arm I (hypofractionated RT, durvalumab)Experimental Treatment2 Interventions

Patients undergo standard of care hypofractionated RT over 5 fractions QD for 5 days in the absence of disease progression or unacceptable toxicity. Within 3-10 days after completion of RT, patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~130

Durvalumab

2017

Completed Phase 2

~3750