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New treatment option for Gallbladder Cancer
Official title Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
ClinicalTrials.gov ID: NCT05833815
What this study is testing
What is Everolimus 10 mg?
Everolimus 10 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gallbladder cancer.
Also referred to as CapOx/GemOx.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Gallbladder cancer (GBC) is the most common malignant tumour of the biliary tract. It is also the most aggressive cancer of the biliary tract with the shortest median survival from the time of diagnosis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Histological proof of cancer with stage III inoperable or Stage IV metastatic disease without any prior treatment.
- Patients with histologic proof of metastatic gallbladder carcinoma who have not had previous treatment for metastatic disease or who received...
- Absolute neutrophil count (ANC) \>= 1500/uL
- Platelet (PLT) \>= 100,000/uL
- Total bilirubin =\< 3mg/dl for gemcitabine and any value for Capecitabine
You likely can't join if
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Clinically significant cardiac disease, especially history of myocardial infarction =\< 6 months, or congestive heart failure (New York Heart...
- Patients taking strong inhibitors or inducers of CYP3A4
- Prior therapy with everolimus
- Any of the following prior therapies:
- Chemotherapy =\< 4 weeks prior to registration
See the full eligibility criteria
- Histological proof of cancer with stage III inoperable or Stage IV metastatic disease without any prior treatment.
- Patients with histologic proof of metastatic gallbladder carcinoma who have not had previous treatment for metastatic disease or who received gemcitabine/capecitabine with or without platinum\>= 6 months ago as part of...
- Absolute neutrophil count (ANC) \>= 1500/uL
- Platelet (PLT) \>= 100,000/uL
- Total bilirubin =\< 3mg/dl for gemcitabine and any value for Capecitabine
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x upper limit of normal (ULN) (=\< 5x ULN in patients with liver metastases)
- Creatinine =\< 1.5 x Institutional ULN
- Alkaline phosphatase =\< 5 x Institutional ULN
- Haemoglobin (Hgb) \>= 8.0 g/dL
- International normalized ratio (INR) and Partial thromboplastin time (PTT) =\ 2 weeks at time of registration)
- Fasting serum glucose \< 1.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
- Ability to provide informed consent
- Willingness to return for follow up
- Life expectancy \>= 12 weeks
- Women of childbearing potential only: Negative serum pregnancy test done =\< 7 days prior to registration.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Clinically significant cardiac disease, especially history of myocardial infarction =\< 6 months, or congestive heart failure (New York Heart Association [NYHA] classification III or IV) requiring use of ongoing...
- Patients taking strong inhibitors or inducers of CYP3A4
- Prior therapy with everolimus
- Any of the following prior therapies:
- Chemotherapy =\< 4 weeks prior to registration
- Immunotherapy =\< 4 weeks prior to registration
- Biological therapy =\< 4 weeks prior to registration
- Radiation therapy =\< 4 weeks prior to registration
- Radiation to \> 25% of bone marrow prior to registration
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
- CNS metastases brain or leptomeningeal metastases that are not stable for at least 4 weeks prior to registration based on imaging, clinical assessment, and use of steroids
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator...
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive
- Current active other malignancy, Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting...
- Severely impaired lung function (i.e., forced expiratory volume in one second [FEV1] \< 1 liter)
- Received immunization with attenuated live vaccines =\< 7 days prior to study entry or during study period; close contact with those who have received attenuated live vaccines should be avoided during treatment with...
- Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C); A detailed assessment of Hepatitis B/C medical history and risk factors will be done at screening for all patients; hepatitis B virus...
The study team makes the final eligibility decision.
Where it's taking place
- Varanasi, Uttar Pradesh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Varanasi, Uttar Pradesh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.