Your session is about to expire
← Back to Search
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
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
HIMALAYA 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.Check my eligibility
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.See study design
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.
HIMALAYA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
HIMALAYA Trial Timeline
Screening ~ 3 weeks3 visits
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
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Objective Response (DoR)
EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration
+13 moreOther outcome measures
Adverse events
Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
HIMALAYA 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
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,603,958 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver cancer diagnosis was confirmed through tissue examination.I have not had brain function issues due to liver disease in the last year.I have a blood clot in the main vein of my liver caused by cancer.I have not had any serious stomach or intestine bleeding in the last year.I have significant fluid buildup in my abdomen.My liver function is good.I am fully active or restricted in physically strenuous activity but can do light work.I have not received any systemic therapy for liver cancer.My liver cancer is at an advanced stage but cannot be treated with local therapies.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
- Group 3: Arm 3
- Group 4: Arm 4
Awards:
This trial has 2 awards, including:- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in this trial for new participants?
"The online portal clinicaltrials.gov has listed this trial as currently seeking patients. The study was originally posted on October 11th, 2017 with the most recent update being from July 7th, 2022."
Answered by AI
Are there any harmful side-effects associated with Durvalumab?
"There is some data supporting the efficacy of durvalumab, and it has been through multiple rounds of testing, so our team at Power rates its safety as a 3."
Answered by AI
Does this research study have an age limit?
"This study is still looking for patients that fit the age criteria of being over 18 but less than 100 years old."
Answered by AI
What are the FDA-approved indications for Durvalumab?
"Durvalumab is a common treatment for hemangiosarcoma. Additionally, Durvalumab has shown efficacy in treating other conditions such as progressive, locally recurrent radioactive iodine-refractory differentiated thyroid carcinoma (dtc), advance directives, and malignant neoplasms."
Answered by AI
Is this the first time that Durvalumab has been used in a trial like this?
"As of the current moment, there are 406 active studies investigating Durvalumab with 74 of them in Phase 3. While a great many of the trials for Durvalumab are running out of Blacktown, New South Wales, there are 15684 total locations conducting clinical trials for Durvalumab."
Answered by AI
If I wanted to join this research project, would I be able to?
"To be eligible for this cancer trial, patients must currently have carcinoma and be aged between 18 and 100. Participants also need to meet the following criteria: Barcelona Clinic Liver cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C, No prior systemic therapy for HCC, Child-Pugh Score class A, ECOG performance status of 0 or 1 at enrollment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger