Treatment for Liver Neoplasms

Phase-Based Estimates
1
Effectiveness
2
Safety
Mayo Clinic Cancer Center, Rochester, MN
Liver Neoplasms+1 More
Eligibility
18+
All Sexes
Eligible conditions
Liver Neoplasms

Study Summary

This study is evaluating whether a drug and a drug combination can kill more tumor cells than a drug alone.

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Eligible Conditions

  • Liver Neoplasms
  • Liver Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Trial Safety

Safety Estimate

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

Trial Design

1 Treatment Groups

Control

This trial requires 55 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment 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.

ControlNo treatment in the control group

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 Cancer Center - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients have Child-Pugh class A or B disease Patients have tumor marker levels that are 2-fold the normal upper limit The disease must be confined to the liver, patients must have no more than 3 tumors, with no tumor exceeding 7 cm in diameter, and the sum total tumor volume less than 200 cm3 show original
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 40-100% Life Expectancy: At least 4 months Hematopoietic: Hemoglobin at least 10 g/dL Platelet count at least 75,000/mm3 Absolute granulocyte count at least 1,000/mm3 PT within 3 seconds of institutional norm Hepatic: SGPT no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Child-Pugh grade A or B Albumin at least 25 g/L Bilirubin no greater than 2.98 mg/dL Absent or easily controlled ascites not requiring routine or intermittent paracentesis Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.3 times ULN OR Creatinine clearance at least 45 mL/min Cardiovascular: No coronary artery disease No New York Heart Association class III or greater cardiac symptoms Other: Not pregnant or nursing No medical or psychiatric condition compromising informed consent No obesity or tumor location that would limit adequate tumor imaging No history of bleeding from liver tumor(s) or gastroesophageal bleeding No known hypersensitivity to cisplatin, bovine collagen, epinephrine, sulfites or radiographic contrast agents No history of encephalopathy
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for hepatocellular carcinoma No concurrent immunomodulating agents Chemotherapy: No prior or concurrent chemotherapy for hepatocellular carcinoma No concurrent cytotoxic agents Endocrine therapy: No prior endocrine therapy for hepatocellular carcinoma Radiotherapy: No prior radiotherapy for hepatocellular carcinoma Surgery: Prior surgical resection of the liver allowed Other: No concurrent use of aspirin, nonsteroidal anti-inflammatory agents, anticoagulants including warfarin sodium (Coumadin), and epinephrine containing medications including topical anesthetics such as bupivacaine HCl No prior investigational agents within 4 weeks of study No concurrent use of probenecid or thiazides Concurrent use of analgesics and antiemetics is allowed Concurrent use of topical and other local anesthetics, locoregional nerve blocks, and systemic agents is allowe

Patient Q&A Section

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

How many people get liver neoplasms a year in the United States?

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There were over 60,000 new cases of primary and secondary liver cancer in 2018. Primary liver cancer constitutes 75% of all cases in the United States. In 2018, this group contributed to a total of 9,950 deaths in the United States. Overall, liver cancer is the fifth most common cause of death as of 2018 in Canada. The most common histological subtypes are hepatocellular carcinoma (HCC), which accounted for 52.3% of all cases in 2018. The second most common subtype was cholangiocarcinoma (38.5%). In the next two leading rank, colorectal carcinoma and carcinoid accounted for 14.6% and 11.2%, respectively.

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What is liver neoplasms?

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Liver neoplasms are an important cause of morbidity and mortality worldwide. They may be benign or malignant, and they may present with a wide spectrum of imaging and pathological findings.

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What causes liver neoplasms?

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Cancerous liver lesions (including hepatocellular carcinomas (HCC) and cholangiocarcinomas (CC) as well as other non-carcinomas) are closely linked to both Hepatitis B virus and fatty liver disease.

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What are the signs of liver neoplasms?

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Signs of liver neoplasms usually occur late in the course of the disease; however, they can be a cause for concern. A large liver mass, palpable hepatomegaly and abdominal discomfort is common. In addition, liver cirrhosis can be inferred when there is excessive appetite or weight loss. Liver metastasis is not usually the initial presentation – however, abdominal pain and liver enlargement can accompany this presentation. Hepatocellular carcinoma may present with an initial presentation of jaundice and right upper quadrant tenderness in 25% of cases. As discussed in more detail, a biopsy should be performed if there is an elevated level of liver enzymes suggestive of liver disease.

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Can liver neoplasms be cured?

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The main obstacle to an effective treatment of hepatic malignancies is inadequate diagnostic criteria. To overcome these problems, the concept of curative tumor therapy should be revived.

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What are common treatments for liver neoplasms?

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The majority of patients are managed with surgical removal of a mass, radiation therapy, or a blend of the two. Rarely are patients treated with chemotherapy, embolization, or targeted therapy.

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What does treatment usually treat?

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Recent findings indicate an association between tumor growth velocity and the aggressiveness of treatment responses in patients who are treated for liver cancer. Patients with fast-growing tumors can be identified on preoperative imaging and may benefit from more aggressive therapy.

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How serious can liver neoplasms be?

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Hepatitis B virus infection, which is associated with cirrhosis, and liver neoplasms often coexist, increasing the risk of developing serious complications, such as cirrhosis or hepatocellular carcinoma.

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What are the latest developments in treatment for therapeutic use?

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There are three major aspects in the treatment of liver tumors: (1) minimizing or eliminating the spread of the cancer cells; (2) removing, or destroying the remaining tumor cells; and (3) reducing the progression of metastases. For a better understanding of the current treatment of liver tumors, we have developed an [Open data, Open access] database. To enable the reader to check the information provided in the table below, the data provided herein are from the Mayo Clinic website for liver cancer.\n

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Does treatment improve quality of life for those with liver neoplasms?

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The findings suggest a high level of patient acceptance of treatment and support for improvement in HRQOL. Because of the small sample size, the authors feel that confirmation awaits larger, matched, comparative studies, but these findings support the potential for benefit in HRQOL from treatment for patients with liver neoplasms.

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Is treatment typically used in combination with any other treatments?

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The most commonly used treatments are mainly palliative for both the tumor and the patient. Treatments used are non-curative by intent: the main goal is to obtain symptom control (pain control and anemia control, e.g., in the case of anemia of chronically low iron intake) or quality of life, or (for a few tumors) the potential to eradicate tumors.

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What is the primary cause of liver neoplasms?

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The prevalence of different risk factors and the pattern of occurrence are different between patients with benign and malignant liver lesions. It is necessary to establish an early diagnosis of malignant liver lesions, so that treatment measures can be taken early and appropriately in the patient's lifetime.

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