Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (… (NCT03937830) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma
United States27 participantsStarted 2021-03-10
Plain-language summary
Background:
Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Most people with advanced HCC survive an average of 6 to 9 months. Researchers are evaluating a combination of treatment drugs to delay the progression of HCC; aiming to help people with HCC live longer.
Objective:
To study the 6-month progression-free survival in people with advanced HCC treated with bevacizumab, durvalumab, and TACE.
Eligibility:
Adults ages 18 and older with intermediate or advanced HCC
Design:
Participants will be screened with a physical exam and medical history. They will have tests to evaluate their hearts as well as blood and urine. A CT and/or MRI scans will be done during the study. If a prior tumor sample is not available; participants may undergo a biopsy. They may undergo an endoscopy of their esophagus and stomach.
Participants will get the study drugs in 21-day cycles:
Two treatment drugs will be injected into a vein every 3 weeks.
Patients will have an interventional treatment procedure done by interventional radiology under sedation; chemotherapy beads will be infused into artery branches in the liver. Participants may have to stay in the hospital for 24 hours for observation, after this procedure. This interventional procedure may be done more than once during the study.
Participants may need to repeat some of the screening tests throughout the study.
Participants may have to stop taking some of their cancer treatment drugs during the study.
Participants will continue on the study until their cancer progresses or until the side effects of the treatment drugs are not tolerable....
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Participants must have
* histopathological confirmation of HCC (Cohorts 1 and 3)
OR
* histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of BTC (Cohort 2).
* Participants should have progressed on standard of care systemic therapy or been intolerant of or have refused standard treatment. Note: For participants enrolled in Cohort 3 (HCC, BCLC stage B), standard of care chemotherapy is not required prior to enrollment.
* Participants must have disease that is not amenable to potentially curative resection, radiofrequency ablation, or liver transplantation
* Participants must have evaluable or measurable disease per RECIST 1.1
* Participants must have at least one lesion accessible for TACE (Cohort 3)
* Participants must have lesions accessible for biopsy and be willing to undergo pre- and posttreatment biopsies
* ECOG performance status of 0 to 1
* If liver cirrhosis is present, patient must have a Child-Pugh score \<7
* Subjects with HCC must have BCLC C (Cohort 1) or BCLC B (Cohort 3)
* Participants must have normal organ and marrow function as defined below:
* absolute neutrophil count greater than or equal to 1,000/mcL
* platelets greater than or equal to 60,000/mcL
* total bilirubin:if cirrhosis present: Part of Child Pugh requirement-If no cirrhosis: bilirubin …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines four treatments — durvalumab, bevacizumab, tremelimumab, and TACE — which is a lot at once; can you walk me through what the expected side effects of this combination might be, and how they'd be managed if I were in this study?
2Since this is a Phase 2 trial, safety and effectiveness are still being studied in a relatively small group of people — does the current evidence from this trial suggest it's performing well enough that it might be a better path than the standard treatments already available for my stage of HCC?
3The trial is active but no longer enrolling new participants, so is there any way to still get access to these drugs in combination — for example through a compassionate use program or another open trial?
4This trial measures how long people go six months without their cancer progressing, which is called progression-free survival — based on my BCLC stage, does that feel like a realistic and meaningful goal for my situation compared to other options?
5TACE is included for BCLC stage B patients but not for stage C — do you know which treatment group I would have fallen into, and does that affect whether this trial's results are relevant to discussing my own treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the 6-month progression free survival (PFS) in participants with advanced HCC BCLC stage B treated with bevacizumab, durvalumab, tremelimumab and TACE
Timeframe: 6 months
2
To evaluate the 6-month PFS in participants with BTC and HCC BCLC stage C treated with bevacizumab, durvalumab and tremelimumab