Futibatinib for Carcinoma, Hepatocellular

1
Effectiveness
2
Safety
Mayo Clinic in Rochester, Rochester, MN
Carcinoma, Hepatocellular+6 More
Futibatinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Hepatocellular

Study Summary

This study is evaluating whether futibatinib and pembrolizumab are safe and effective in treating patients with FGF19 positive liver cancer.

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Eligible Conditions

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Advanced Hepatocellular Carcinoma (HCC)
  • Metastatic Hepatocellular Carcinoma
  • BCLC Stage B Hepatocellular Carcinoma
  • BCLC Stage A Hepatocellular Carcinoma
  • BCLC Stage C Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Futibatinib will improve 1 primary outcome and 4 secondary outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of At 6 months.

At 6 months
Progression-free survival (PFS)
Year 5
Overall survival (OS)
Up to 5 years
Change in quality of life (QOL)
Incidence of adverse events
Overall response rate (ORR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment (futibatinib, pembrolizumab)

This trial requires 25 total participants across 2 different treatment groups

This trial involves 2 different treatments. Futibatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (futibatinib, pembrolizumab)Patients receive futibatinib PO QD on days 1-21 for cycles 1-9, and days 1-42 for subsequent cycles and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for cycles 1-9 and every 42 days for subsequent cycles for up to 2 years in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Hepatocellular or one of the other 6 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
on day of race Pre-registration means you must be at least 18 years old on the day of the race. show original
patients who are not candidates for curative surgery Patients with confirmed hepatocellular carcinoma who are not candidates for surgery may be candidates for pre-registration. show original
You can have either an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2. show original
We are asking for your voluntary participation in providing tissue specimens for our research show original
for patients to be enrolled in the study People who want to enroll in the study must have tumor tissue that is positive for FGF19 by messenger ribonucleic acid (mRNA) or immunohistochemistry (IHC). show original
The person received at least one prior systemic treatment for HCC, which is a type of cancer. show original
Some people might think that you can't have radiation therapy if you've had chemoembolization, radioembolization, or other local ablative therapies, or if you've had a hepatic resection show original
) The patient has a measurable disease by any imaging modality as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in at least one site that has not been treated with radiation or liver directed therapy (including bland, chemo- or radio-embolization, or ablation). show original
The patient does not need to pre-register if they are able to swallow oral medication. show original
(eg, radiofrequency ablation [RFA], cryoablation, or percutaneous ethanol injection [PEI]) HCC that can't be cured with surgery, a transplant, or radiofrequency ablation (RFA) is sometimes treated with cryoablation or percutaneous ethanol injection (PEI). show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes carcinoma, hepatocellular?

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There were no significant interactions for age, smoking, diabetes, alcohol use, and obesity in the pooled model. In a recent study, findings highlights that obesity does not interact with liver cirrhosis to affect the development of HCC. In addition to BMI, triglyceride levels and ALT may increase risk of HCC in a U-like pattern. Overall, results are reassuring. Lifestyle factors of alcohol use, smoking, and obesity are independent risk factors. The risk of HCC in people with cirrhosis increases with age, which corroborates the concept of cirrhosis acting a "port of entry" for the development of HCC.

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What is carcinoma, hepatocellular?

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Carcinoma, hepatocellular, is a tumour originating in cells which line the inner surfaces of organs, such as the liver. Although the liver is a vital organ which serves as a site for many metabolic processes, the cancerous growth of the disease may cause health problems. Hepatocellular carcinoma is one form of cancer in which the disease has spread to the pancreas, where it is called pancreatic carcinoma. Pancreatic carcinoma is associated with a poor prognosis.

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What are the signs of carcinoma, hepatocellular?

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A high degree of clinical suspicion is needed to identify all patients with metastatic disease because of a poorer prognosis. The detection of occult hepatocellular carcinoma in patients with cirrhosis is possible through the use of imaging techniques and is associated with improved survival.

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Can carcinoma, hepatocellular be cured?

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While it is possible to achieve complete remission, only about 24% of all the cases can be cured. This justifies the development of new treatment modalities.

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What are common treatments for carcinoma, hepatocellular?

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Treatment for cancers, hepatocellular includes hepatic surgery and hepatic embolization or radiofrequency ablation. However, chemotherapeutic agents alone provide a limited therapeutic result, and therefore additional therapies must be considered.

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How many people get carcinoma, hepatocellular a year in the United States?

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The numbers of people affected by this type of cancer in the United States appear to have increased dramatically in recent years. Approximately 28,700 people in the US were diagnosed with this cancer in 2003. With about 56,000 new cases of carcinoma, hepatocellular in 2005 these numbers will rise to a similar degree in 2006.

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Have there been any new discoveries for treating carcinoma, hepatocellular?

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No new anticancer agents have emerged in the past 10 years that have changed the strategy for treating HCC. The 5-year survival of patients with curative therapy remains approximately 60%, but the prognosis is worse for patients with locoregional HCC (recurrence and metastasis) and those with disease confined to the liver at presentation. For patients with palliative therapy and a disease-free interval from one to three years prior to the development of HCC, the survival rate approaches 18 percent.

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What is the average age someone gets carcinoma, hepatocellular?

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Among Taiwanese patients and patients in Japan, the average age at diagnosis were 64 and 63 years, respectively, with little gender disparity. Among the Taiwanese patients, the average age at diagnosis was less than 40 years, and among the Japanese patients less than 60 years. According to WHO report, the median age at diagnosis is about 65 years in Asia. Taiwan patients and Japanese patients may have different lifestyles and environmental background, but they are similarly under the high risk for hepatatic carcinoma.

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Have there been other clinical trials involving futibatinib?

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In our population, [no adverse events occurred in 82.3 percent of randomized patients] patients taking futibatinib experienced fewer and less severe adverse events compared with first-line chemotherapy. Among AEs which were reported, [neutropenia was seen in 2.0 percent of patients with futibatinib] a statistically significant lower incidence of neutropenia was found compared with cytotoxic agents. In contrast, no [futibatinib-related deaths were reported in this study] patients in our cohort was notified of any [futibatinib-related] deaths.

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What does futibatinib usually treat?

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Futibatinib therapy is a safe, well tolerated, and potentially effective treatment aimed at targeting a new class of cancer with an intriguing potential for improvement of outcomes for patients with HCC.

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Does futibatinib improve quality of life for those with carcinoma, hepatocellular?

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Even though futibatinib does not improve the overall survival of patients with HCC, it improves QoL. Results from a recent clinical trial suggest that it may be appropriate to consider futibatinib for patients with advanced HCC.

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Is futibatinib typically used in combination with any other treatments?

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It is commonly used as a monotherapy or in combination with chemotherapy for patients in phase III studies. Other combinations have been used, including it with anti-angiogenic agents, and with bortezomib and/or dexamethasone or temsirolimus. However studies in the literature were not adequate in terms of their design, methodology or relevance to the population of interest included patients with advanced HCC.

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