In short
There are currently 2 ongoing clinical trials investigating treatments for biliary tract disorder. These studies are testing the combination of immunotherapy with chemotherapy in patients with advanced disease that cannot be treated with surgery. The trials are being conducted in multiple European countries including Spain, Italy, Germany, and France.
Clinical trial locations
- France
- Germany
- Italy
- Spain
Study on Durvalumab with Chemotherapy for Patients with Advanced Biliary Tract Cancer
This trial is investigating the combination of durvalumab with standard chemotherapy in patients who have advanced disease affecting the bile ducts, gallbladder, or the area where the bile duct and pancreatic duct meet. The study focuses on patients who have not received prior treatment for their advanced cancer.
Main inclusion criteria: Participants must be at least 18 years old and weigh more than 30 kg. They must have advanced disease that cannot be removed by surgery, either at initial diagnosis or as a recurrence after previous curative treatments. Participants need to have a performance status of 0 to 2, which means they can perform most daily activities with varying degrees of assistance. They must have at least one measurable tumor, adequate organ and bone marrow function, and a life expectancy of at least 12 weeks. Women who can become pregnant must have a negative pregnancy test, and both men and women must use reliable birth control methods during and after the study.
Main exclusion criteria: Patients with other types of cancer, severe allergic reactions to the study drugs, serious heart problems, uncontrolled high blood pressure, or active infections including hepatitis B, hepatitis C, or HIV cannot participate. Pregnant or breastfeeding women are excluded. Patients who have received another investigational drug within the last 4 weeks, have a history of autoimmune diseases, or have untreated brain metastases are also excluded. Those who have had major surgery within the last 4 weeks cannot join the study.
Focus of the trial: The study aims to assess the safety of combining durvalumab with gemcitabine-based chemotherapy. Participants will receive durvalumab through an intravenous infusion along with chemotherapy drugs such as gemcitabine and possibly carboplatin, oxaliplatin, or cisplatin. The treatment will be monitored closely through regular visits, blood tests, and imaging studies to evaluate both the treatment's impact and any side effects. The study includes a placebo group for comparison and will continue until March 2025.
Investigational drugs: Durvalumab is an immunotherapy medication that helps the immune system recognize and attack cancer cells by blocking a protein called PD-L1. Gemcitabine-based chemotherapy uses drugs to kill cancer cells or stop them from growing. In this trial, durvalumab is combined with gemcitabine to determine if the combination is more effective than chemotherapy alone.
Study on Durvalumab and Chemotherapy for Patients with Advanced Biliary Tract Cancer
This trial is examining the use of durvalumab combined with chemotherapy for treating advanced cancers of the bile ducts, gallbladder, and the area where the bile duct meets the small intestine. The study uses a single-arm, open-label design, meaning all participants receive the same treatment and everyone knows what is being given.
Main inclusion criteria: Participants must be at least 18 years old and weigh more than 30 kg. They must have confirmed advanced or metastatic disease, either as a new diagnosis or as a recurrence after previous curative treatments such as surgery or chemotherapy. A performance status of 0 to 2 is required, and participants must have at least one measurable tumor. Those with hepatitis B infection must be on antiviral therapy before joining and continue it throughout the study. Adequate organ and bone marrow function is necessary, along with a life expectancy of at least 12 weeks. Participants must provide informed consent and agree to optional genetic research. Birth control requirements are the same as the first trial.
Main exclusion criteria: Patients with other types of cancer, those outside the specified age range, or those unable to follow study procedures are excluded. Certain unspecified medical conditions that might interfere with the study, pregnancy, breastfeeding, recent participation in another clinical trial, allergies to study medications, and severe or uncontrolled health issues also prevent participation.
Focus of the trial: The study assesses the safety of durvalumab when used with gemcitabine-based chemotherapy. Participants will receive durvalumab as an intravenous infusion along with chemotherapy, which may include gemcitabine, cisplatin, oxaliplatin, carboplatin, or inflectra. The treatment involves regular infusions according to a specific schedule, with ongoing monitoring through check-ups, blood tests, and imaging to evaluate effectiveness and side effects. Some participants may receive a placebo for comparison purposes. The study is expected to continue until 2026.
Investigational drugs: Durvalumab is an immune checkpoint inhibitor that enhances the body's immune response against cancer cells by blocking the PD-L1 protein, which normally helps cancer cells evade the immune system. Gemcitabine-based chemotherapy serves as background therapy, using drugs to kill cancer cells or prevent their growth, commonly used for various cancer types including biliary tract cancers.
Summary
Both ongoing clinical trials are investigating the same therapeutic approach: combining the immunotherapy drug durvalumab with gemcitabine-based chemotherapy for patients with advanced disease. The trials share very similar inclusion and exclusion criteria, focusing on patients aged 18 or older with inoperable advanced or metastatic disease who have adequate organ function and a performance status that allows them to participate in clinical research.
Geographically, both studies are being conducted in the same four European countries: Spain, Italy, Germany, and France, suggesting a coordinated European effort to evaluate this treatment approach. The trials emphasize safety assessment as a primary goal, with close monitoring of participants through regular visits and assessments. Both studies require participants to use reliable birth control methods and exclude patients with certain infections, autoimmune diseases, or other serious medical conditions that could complicate treatment or study results.
The focus on durvalumab, an immune checkpoint inhibitor that blocks PD-L1, reflects current interest in immunotherapy approaches for these cancers. By combining immunotherapy with traditional chemotherapy, researchers aim to determine whether this combination offers better results than chemotherapy alone while maintaining an acceptable safety profile.
