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Checkpoint Inhibitor

Immunotherapy for Liver Cancer (HIMALAYA Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HCC based on histopathological confirmation
Child-Pugh Score class A
Must not have
Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
Main portal vein tumor thrombosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 4 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether two immunotherapy drugs or one immunotherapy drug is better than the standard-of-care drug for people with liver cancer that can't be removed by surgery and who haven't gotten any other systemic therapy.

Who is the study for?
This trial is for adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic therapy before and can't have targeted local treatments. They should be in relatively good health (Child-Pugh A, ECOG 0 or 1). People with serious fluid buildup in the abdomen, major blood vessel blockage by the tumor, certain viral infections, recent brain issues related to liver disease, or a history of significant GI bleeding can't join.
What is being tested?
The study compares three approaches: one group gets Durvalumab plus Tremelimumab; another gets just Durvalumab; and a third receives Sorafenib. It's designed to see which treatment is better as a first-line option for unresectable Hepatocellular Carcinoma.
What are the potential side effects?
Durvalumab and Tremelimumab might cause immune-related problems like inflammation in various organs, skin reactions, hormone gland issues leading to fatigue or weight changes. Sorafenib may lead to diarrhea, hand-foot skin reactions, high blood pressure and tiredness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver cancer diagnosis was confirmed through tissue examination.
Select...
My liver function is good.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have not received any systemic therapy for liver cancer.
Select...
My liver cancer is at an advanced stage but cannot be treated with local therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had brain function issues due to liver disease in the last year.
Select...
I have a blood clot in the main vein of my liver caused by cancer.
Select...
I have significant fluid buildup in my abdomen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 4 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
Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
Secondary study objectives
Disease Control Rate (DCR)
Duration of Objective Response (DoR)
EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration
+13 more
Other study objectives
Adverse events

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
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3Experimental Treatment2 Interventions
Durvalumab in combination with tremelimumab (Regimen 2)
Group II: Arm 2Experimental Treatment2 Interventions
Durvalumab in combination with tremelimumab (Regimen 1)
Group III: Arm 1Experimental Treatment1 Intervention
Durvalumab
Group IV: Arm 4Active Control1 Intervention
Sorafenib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,122,269 Total Patients Enrolled
1 Trials studying Liver Cancer
40 Patients Enrolled for Liver Cancer

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03298451 — Phase 3
Liver Cancer Research Study Groups: Arm 1, Arm 2, Arm 3, Arm 4
Liver Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03298451 — Phase 3
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03298451 — Phase 3
~162 spots leftby Dec 2025
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