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New treatment option for Resectable Biliary Tract Cancer
Official title Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer
ClinicalTrials.gov ID: NCT05640791
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, being studied as a potential treatment for resectable biliary tract cancer.
Also referred to as Cisplatinum.
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
- This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC.
- 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 to 75
You may be able to join if
- The pathological diagnosis has confirmed biliary tract malignancy;pathological evidence may be obtained from biopsy/puncture, surgical resection...
- Computed tomography (CT) or magnetic resonance imaging (MRI) shall be performed with high-quality cross-sectional imaging, and diagnosed as...
- T-stage ≥ Ib (Ib-IV)
- Solitary lesion \> 5 cm
- Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable
You likely can't join if
- Patients who received PD-1, PD-L1, PD-L2, CTLA-4 inhibitors before enrollment, or patients who directly received another stimulatory or co inhibitory...
- Used any other research drugs within 4 weeks before enrollment;
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis...
- With congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA...
- Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug...
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
See the full eligibility criteria
- The pathological diagnosis has confirmed biliary tract malignancy;pathological evidence may be obtained from biopsy/puncture, surgical resection specimens, or a formal pathology report.
- Computed tomography (CT) or magnetic resonance imaging (MRI) shall be performed with high-quality cross-sectional imaging, and diagnosed as resectable high-risk biliary malignant tumors, limited to the liver, bile duct...
- T-stage ≥ Ib (Ib-IV)
- Solitary lesion \> 5 cm
- Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable
- Presence of major vascular invasion but still technically resectable
- Suspicious or involved regional lymph nodes (N1)
- No distant extrahepatic disease (M0)
- The patient's gender is not limited, and the age is 18-75 years old; Life expectancy\>3 months;
- Within one week of enrollment, the ECOG PS score was 0 or 1;
- No serious complications, such as hypertension, coronary heart disease and psychiatric history, and no serious allergic history; Non pregnancy and non lactation period;
- The patient's organ and blood system functions meet the requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
- Platelet count ≥ 100 × 10\^9/L
- Hemoglobin ≥ 90 g/L
- Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN
- Albumin ≥ 3g/dL
- Creatinine ≤ 1.5 x ULN
- The patient can understand and sign the informed consent form to participate in the trial study; can follow up with good compliance.
- Patients who received PD-1, PD-L1, PD-L2, CTLA-4 inhibitors before enrollment, or patients who directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, CD137);
- Used any other research drugs within 4 weeks before enrollment;
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after...
- With congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher...
- Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause\>38.5 ° C occurred during...
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Test drug allergy;
- Suffering from uncontrollable mental illness;
- Peripheral neuropathy of grade 2 or above according to CTCAE 4.0. In CTCAE 4.0, grade 2 sensory neuropathy is defined as "moderate symptoms; restriction of activities of daily living (ADL)";
- Occurrence of serious and/or uncontrollable diseases at the same time may affect participation in the study, such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic...
- Pregnancy (positive pregnancy test) or lactation;
- Diseases of central nervous system (CNS), except for brain metastasis treated. The treated brain metastatic tumor is defined as confirmed by clinical examination and brain imaging (MRI or CT) during the screening...
- Other cancers in the past (within the past 5 years) or at the same time, excluding non melanoma skin cancer and carcinoma in situ;
- History of allergy or hypersensitivity to any study drug;
- Current abuse of alcohol or illicit drugs;
- Unable or unwilling to sign the informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 Tianjin, Tianjin Municipality, 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.