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New treatment option for Biliary Tract Cancers (BTC)
Official title A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
ClinicalTrials.gov ID: NCT06611345
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract cancers (btc).
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
- Unresectable BTC represents an area of unmet medical need due to its very aggressive nature, limited treatment options, and poor prognosis. This study is to evaluate the efficacy and safety of adding TTF to the established regimen of durvalumab plus GemCis for the treatment of patients with previously untreated, unresectable BTC.
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 75
You may be able to join if
- Willing and able to provide written informed consent for the trial.
- Male or female patients between the ages of 18 and 75 years (including 18 and 75 years).
- Body weight \> 30 kg.
- Histologically confirmed, unresectable adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and...
- Patients with the previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
You likely can't join if
- Patients previously received systemic treatment as the first-line therapy.
- Ampullary carcinoma.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease]...
- Uncontrolled intercurrent illness, including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina...
- History of another primary malignancy, except for: Malignancy was treated with curative intent and with no known active disease ≥5 years before the...
See the full eligibility criteria
Who can join
- Willing and able to provide written informed consent for the trial.
- Male or female patients between the ages of 18 and 75 years (including 18 and 75 years).
- Body weight \> 30 kg.
- Histologically confirmed, unresectable adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- Patients with the previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
- Patients with recurrent disease \>6 months after curative surgery or \>6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible (but he/she does not receive systemic treatment...
- At least 1 measurable lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- ECOG PS of 0 or 1.
- Life expectancy ≥12 weeks at the time of screening.
- No prior exposure to immune-mediated therapy, including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.
- Patients must have adequate organ function as indicated by the following laboratory values: Hemoglobin ≥9.0 g/dL; Absolute neutrophil count ≥1.5 ×109/L; Platelet count ≥100 ×109/L. No blood transfusion, granulocyte...
- Patients (women of childbearing potential and males with fertile female partners) must be willing to use the currently accepted reliable contraception method from the time of screening throughout the total duration of...
- Patients with HBV infection (as characterized by positive hepatitis B surface antigen [HBsAg] and/or anti-hepatitis B core antibodies (anti-HBc) with detectable HBV deoxyribonucleic acid (DNA) [above the limit of...
- Able to operate TTF device independently or with the help of a caregiver.
What rules you out
- Patients previously received systemic treatment as the first-line therapy.
- Ampullary carcinoma.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus...
- Uncontrolled intercurrent illness, including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung...
- History of another primary malignancy, except for: Malignancy was treated with curative intent and with no known active disease ≥5 years before the first dose of the investigational product (IP) and of low potential...
- History of leptomeningeal carcinomatosis.
- History of active primary immunodeficiency.
- Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), or human...
- Any unresolved toxicity NCI CTCAE Grade ≥2 from a previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with Grade ≥2 neuropathy...
- Brain metastases or spinal cord compression (including asymptomatic and adequately treated disease). Patients with suspected brain metastases at screening should have an MRI (preferred) or CT scan, each preferably with...
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Radiation therapy, including palliative radiation, is not allowed before the study, with an exception of radiation given in an adjuvant setting.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note that patients, if enrolled, should not receive a live vaccine while receiving IP and up to 30 days after the last dose of IP.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note that minor surgery of isolated lesions for palliative intent is acceptable if performed more than 14 days...
- Patients who have received prior immune-mediated therapy, including, but not limited to, other anti-PD-1, anti-PD-L1, or anti-CTLA-4.
- Prior locoregional therapy such as radioembolization.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, or topical steroids, or local steroid...
- Participation in another clinical study with an IP administered in the last 3 months.
- Previous IP assignment in the present study.
- Concurrent enrollment in another clinical study, unless it is an observational (non-treatment) clinical study or during the follow-up period of an treatment study.
- Prior randomization or treatment in a previous durvalumab clinical study, regardless of treatment arm assignment.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to use effective birth control from screening to 180 days after the last dose of GemCis or 90...
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Active infection of hepatitis C as evidenced by detectable HCV RNA per local laboratory. Patients who test positive for hepatitis C (HCV) antibody may be enrolled if HCV RNA is undetectable.
- Known allergy or hypersensitivity to medical adhesives or hydrogel.
- Implantable electronic medical devices such as cardiac pacemakers.
- Metallic medical devices, such as bone nails, were implanted in the chest and abdomen.
- Patients with infection, ulcer or unhealed wound at the electrode application site.
- Patients with symptomatic ascites, pleural effusion, pericardial effusion, etc., unless the condition is well controlled after clinical treatment (including therapeutic puncture).
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, China
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, China. 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.