Regorafenib for Biliary Tract Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, MO
Biliary Tract Cancer+1 More
Regorafenib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Biliary Tract Cancer

Study Summary

This study is evaluating whether a combination of two drugs may help treat advanced stage biliary track carcinoma.

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Eligible Conditions

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms
  • Advanced Biliary Tract Cancer(BTC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Regorafenib will improve 2 primary outcomes and 4 secondary outcomes in patients with Biliary Tract Cancer. Measurement will happen over the course of At the end of each cycle (28 days) until disease progression or 2 years (end of study), whichever occurs first.

Day 30
Incidence of treatment related adverse events
Year 2
Progressin Free Survival (PFS)
Year 2
Disease Control Rate (DCR)
Overall Response (OR)
Overall Response Rate (ORR)
Overall Survival (OS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Dose Finding Regorafenib

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Regorafenib 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 1 & 2 and have already been tested with other people.

Dose Finding RegorafenibWe will use a 3 + 3 design with two dose levels of 80 mg and 120 mg to discover the Maximum Tolerated Dose (MTD) for regorafenib
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: start of treatment to eot or 2 years (end of study), whichever occurs first
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly start of treatment to eot or 2 years (end of study), whichever occurs first for reporting.

Closest Location

University of Kansas Cancer Center - Lee's Summit - Lee's Summit, MO

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
The patient OR the participant's legally authorized representative is able to understand the study, and they are willing to sign a written informed consent. show original
A person with an ECOG Performance Status of 0 - 1 is considered to be ambulatory and able to carry out most normal activities. show original
The patient has a measurable disease with at least 1 lesion that is a target for treatment according to RECIST 1.1 show original
People with cholangiocarcinoma or gallbladder cancer that has progressed after one line of treatment, or who have failed adjuvant therapy, may be eligible for this study. show original
No clinically significant toxicities from any previous treatments, unless the adverse events are stable with supportive therapy. show original
Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) will be allowed provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until international normalized ratio/ partial thromboplastin time (INR/PTT) is stable based on a measurement that is pre-dose as defined by the local standard of care
Has undergone at least one line of therapy, with no restrictions on the type of previous treatment. show original
Can swallow tablets and self-administer medication
is necessary for patients on the liver transplant waiting list show original
The patient is expected to live for at least 3 more months. 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.

How many people get biliary tract cancer a year in the United States?

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Approximately 16,000 new cases of biliary tract cancer are diagnosed each year in the United States. This results in a death rate of around 3,000 people each year. In addition to a higher rate of mortality, the patients diagnosed with biliary tract cancer also have substantially longer overall and disease-free survival times than patients diagnosed with other cancers.

Unverified Answer

What is biliary tract cancer?

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Biliary tract cancer, also referred to as biliary cancer, is an aggressive disease of hepatic bile ducts and gallbladder. More than 50% of cases have an underlying primary site in gastrointestinal tract, and over half of cases are caused by cholangiocarcinoma. Bile duct cancer is the primary reason for mortality in patients with biliary tract cancer. The average age of diagnosis is 61. The disease is diagnosed in less than 15 % at the time of first symptoms.

Unverified Answer

What are the signs of biliary tract cancer?

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Bicompressive symptoms of the jaundice, abdominal mass or abdominal pain are highly suggestive of cancer. Other significant symptoms may be jaundice, haematuria, hepatocellular growth, leukocytosis or decreased white blood cell count.\n

Unverified Answer

What are common treatments for biliary tract cancer?

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A number of treatment options are available for biliary tract cancer. Surgery may be the most effective therapy, but for symptomatic tumors, it may be ineffective and may not be a definitive treatment for the disease. For advanced or metastatic disease, palliative care may be necessary. No treatment is effective for prevention. If an intact gallbladder is present, cholangiocarcinoma may be treated with an appropriate surgical resection. In terms of treatment for recurrent disease, surgery may be preferable with radiation or chemotherapy before chemotherapy. Chemotherapy offers a chance of long-term survival, especially in the setting of curative procedures.

Unverified Answer

Can biliary tract cancer be cured?

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Biliary tract cancers can be cured. Despite advances in diagnostics, multimodality oncological treatments are not yet validated for biliary tract cancer. Further, new data on the role of immunomodulatory agents and on the treatment of secondary cholangiocarcinoma are required.

Unverified Answer

What causes biliary tract cancer?

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Multiple carcinogens, such as tobacco, are associated with biliary tract cancer. In most cases, a specific type of cancer must occur before biliary tract cancer appears in an individual. Biliary tract cancer can also be caused by gallstones left in the duodenum long enough for bacterial infection to occur. This infection may be from the bacteria, or the bacteria may be the cancer. The last theory may account for why older patients are at increased risk for biliary tract cancer. It seems to occur after age 50 years.

Unverified Answer

What is the primary cause of biliary tract cancer?

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[Carcinogenesis of biliary tract cancer is related to the development of chronic inflammations in a relatively long period with high susceptibility to carcinogenic factors. The carcinogenesis is the most influential factor in the development of biliary tract cancer, and biliary tract cancer tends to occur in the elderly.

Unverified Answer

How quickly does biliary tract cancer spread?

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There are few data on the survival, treatment response, or the incidence of the spread of biliary tract cancer. Thus, the best available information from many centers, including this study, on survival and treatment response to treatment should be interpreted cautiously, and a randomized trial should be conducted in the future to define the survival of patients who have biliary tract cancer.

Unverified Answer

Does biliary tract cancer run in families?

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Findings from a recent study do not support the notion that the occurrence of any of the 3 biliary tract tumors in either the affected family members or the available case controls were significantly different from that in the general population. We must now look at modifier genes and gene-gene interactions in a population-based, rather than family-based study.

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Have there been any new discoveries for treating biliary tract cancer?

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Recent advances in biliary tract cancer therapy have improved local control and overall outcome. New approaches use minimally invasive surgical treatments to keep the cancer in check and treat metastases. Immunotherapy with immune checkpoint inhibitors has been a mainstay in chemotherapy of advanced biliary tumors. Chemotherapy remains the mainstay of therapy for resectable disease. The new generation of targeted therapy agents with tyrosine kinase inhibitors like ALK-positive tumors, gastroesophageal cancer, and EGFR-mutant tumors continues to improve overall outcomes. Radiation continues to be the standard of care in biliary tract cancer treatment and can reduce local recurrence by 55%.

Unverified Answer

What is the average age someone gets biliary tract cancer?

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For every 100,000 people in the United States, there were an average of 25 biliary tract cancers in men and 16 in women. Because men are usually older than women, the rate of biliary tract cancer is higher in men than in women.

Unverified Answer

How serious can biliary tract cancer be?

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The mortality of patients with pancreatic cancer and extrapancreatic bile duct cancer is comparable. However, in patients with bile duct cancer (CBD), a high percentage of patients (42%) will die of liver failure. The current study will help physicians, oncologists, and patients understand the disease process, and how serious it can be.

Unverified Answer
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