CLINICAL TRIAL

Cabozantinib for Carcinoma, Hepatocellular

Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether a drug called cabozantinib and a drug called nivolumab are safe and effective for people with hepatocellular carcinoma.

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About the trial for Carcinoma, Hepatocellular

Eligible Conditions
Liver Cancer · Liver Neoplasms · Hepatocellular Carcinoma · Carcinoma, Hepatocellular

Treatment Groups

This trial involves 2 different treatments. Cabozantinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Nivolumab
DRUG
Experimental Group 2
Cabozantinib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Cabozantinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Has Barcelona Clinic Liver Cancer (BCLC) Stage-C disease or BCLC Stage-B disease not amenable to locoregional therapy or refractory to locoregional therapy and not amenable to a curative treatment approach (see Appendix 12.8).
Has a Child-Pugh A liver score within 7 days of first dose of study drug.
Has measurable disease based on RECIST 1.1 as confirmed by the MD Anderson radiologist.
Patients who have chronic, untreated hepatitis C virus (HCV) are allowed. Has recovered to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
Has a performance status of 0 or 1 using the Eastern Cooperative Oncology Group performance status scale within 7 days of first dose of study drug.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: through study completion, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: through study completion, an average of 1 year.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cabozantinib will improve 1 primary outcome in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of through study completion, an average of 1 year.

To evaluate overall response rate
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR

Patient Q & A Section

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

Can carcinoma, hepatocellular be cured?

Liver transplantation could prolong the survival time of HCC patients who had received preoperative treatment with TACE. If the patient had residual disease after liver transplantation, further treatments might not be effective in improving service survival; thus, the postoperative adjuvant therapy might fail and have adverse effects, which would reduce the chance of survival.

Anonymous Patient Answer

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

There were several types of human liver cancers whose prognosis and treatment had not been improved since the 1980s. In this review, we summarize the present knowledge on the carcinomas of the liver.

Anonymous Patient Answer

What is the average age someone gets carcinoma, hepatocellular?

The average age of first diagnosis for HCC was 74 years in men and 77 years in women, compared to 69 years in men and 67 years in women for CCA. The incidence rates of HCC were 2-fold higher than that for CCA in both sexes, but the prevalence rate was slightly higher than that for CCA in both sexes (3.3 times higher in men vs 3.1 times higher in women). The male/female ratio of incidence and prevalence were similar to those observed for CCA, but the male/female ratios were 7.0 and 8.3 times higher for HCC in men and women, respectively.

Anonymous Patient Answer

Is cabozantinib typically used in combination with any other treatments?

Cabozantinib is frequently combined with other anticancer agents including EGFR-TKI, GEMCITIB, PARP inhibitors, and BSH_RAS inhibition. Results from a recent paper highlights the need for effective therapeutic regimens that incorporate cabozantinib, which will likely become more available over time.

Anonymous Patient Answer

What are common treatments for carcinoma, hepatocellular?

The treatment choices vary considerably between geographic regions and even among individuals. Given the enormous cost burden associated with cancer, there still remains an important role for innovative therapies that are not yet on the market, especially in areas where healthcare resources are scarce.

Anonymous Patient Answer

Has cabozantinib proven to be more effective than a placebo?

Cabozantinib was superior to placebo in terms of efficacy. Although numerically superior, the difference between the two groups was not statistically significant. This suggests that activities of c-Met may be involved in resistance to cabozantinib therapy.

Anonymous Patient Answer

What are the common side effects of cabozantinib?

Cabozantinib was well tolerated In a recent study population and induced many common adverse events including nausea, fatigue, cough, dizziness, and hypotension. Cabozantinib did not appear to impair liver function tests. Because of its potent anticancer activity, further investigation of cabozantinib as a unique therapy for NSCLC is warranted.

Anonymous Patient Answer

Have there been other clinical trials involving cabozantinib?

Cabozantinib was well tolerated when administered as part of chemotherapy for advanced hepatocellular carcinoma in combination with sorafenib. Recent findings of this study warrant further investigation of the safety and efficacy of cabozantinib as a monotherapy in HCC.

Anonymous Patient Answer

What is the survival rate for carcinoma, hepatocellular?

The survival rate for hepatocellular carcinomas is lower than that for other types of malignant neoplasms. However, the survival rates for HCC do not seem to differ significantly from those of other major malignancies in Japan.

Anonymous Patient Answer

What is the primary cause of carcinoma, hepatocellular?

The most frequent primary tumor was HCC (65.9%), followed by CPKD (12.3%) and CCC (10.7%). Until then, the primary tumors of HCC were thought to have been caused by HBV. Results from a recent paper showed that there was no relationship between HCC and HBV infection. Moreover, we found that more than half the primary tumors of HCC were not associated with hepatitis B virus infection. Therefore, other hepatotropic viruses such as HCV and HDV might also be involved in the development of HCC.

Anonymous Patient Answer

What are the latest developments in cabozantinib for therapeutic use?

Cabozantinib has been used for the treatment of RAS wild-type metastatic renal cell carcinoma since 2009. In 2010, the FDA approved cabozantinib as a second line therapy for metastatic papillary renal cell carcinoma. Subsequently, in 2011, the U.S. Food and Drug Administration (FDA) granted Oridis Pharma's application for the approval of cabozantinib as a first-line therapy for metastatic medullary thyroid cancer. In March 2013, Oridis Pharma announced the receipt of exclusivity from the FDA for cabozantinib for the treatment of metastatic medullary thyroid cancer.

Anonymous Patient Answer
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