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New treatment option for Billiary Track Cancer
Official title Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
ClinicalTrials.gov ID: NCT06001658
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for billiary track cancer.
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
- The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.
- Resectable BTC (biliary tract cancer)
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Age ≥18 years.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80
You likely can't join if
- Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
- Have been diagnosed with another cancer or myeloproliferative disorder whose natural history or treatment has the potential to interfere with safety...
- Has a known history of Human Immunodeficiency Virus (HIV)/AIDS
- Has active co-infection with HBV and HDV.
See the full eligibility criteria
- Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.
- Resectable BTC (biliary tract cancer)
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Age ≥18 years.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80
- Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- Patients must have adequate liver function defined by study-specified laboratory tests.
- Patients with chronic or acute HBV or HCV infection must have disease controlled prior to enrollment.
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.
- For both Women and Men, must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
- Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
- Have been diagnosed with another cancer or myeloproliferative disorder whose natural history or treatment has the potential to interfere with safety or how well it works assessment of this study's investigational drugs.
- Has a known history of Human Immunodeficiency Virus (HIV)/AIDS
- Has active co-infection with HBV and HDV.
- Has a diagnosis of immunodeficiency.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Systemic or topical corticosteroids at immunosuppressive doses.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Prior tissue or organ allograft or allogeneic bone marrow transplantation, including corneal transplants.
- Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social...
- Evidence of clinical ascites.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Previously identified allergy or hypersensitivity to monoclonal antibodies or any component of the study treatment formulations.
- Pregnant or breastfeeding.
- WOCBP and men with female partners (WOCBP) who are not willing to use contraception.
- people unable to undergo venipuncture and/or tolerate venous access.
- Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. 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.