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New treatment option for Biliary Tract Cancer (BTC)
Official title Paclitaxel mIcelle Later-line cOmbined immunoTherapy for Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07159204
What this study is testing
What is Paclitaxel polymer micelle immunocombination?
Paclitaxel polymer micelle immunocombination is an investigational medicine, being studied as a potential treatment for biliary tract cancer (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
- After the standard first-line treatment, the treatment regimen was adjusted to a paclitaxel polymer micellar-based immunotherapy combination regimen
- 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 people voluntarily participated in the study and agreed to sign the written informed consent, with good compliance and follow-up, and were at...
- Patients with advanced biliary carcinoma diagnosed by imaging and histology as unresectable, recurrent, locally advanced, or with metastatic lesions...
- Radical surgery/local treatment, including focal excision, ablation, transcatheter arterial chemoembolization, hepatic arterial infusion...
- Patients were intolerant or failed for ≥1 month after first-line systemic therapy, required palliative care, and patient adverse events were...
- At least one measurable lesion (a spiral CT scan of a measurable lesion ≥10mm or an enlarged lymph node ≥15mm, as required by RECIst version 1.1).
You likely can't join if
- Those who have previously received treatment with immune checkpoint inhibitors, lenvatinib or paclitaxel, or are known to be allergic to or...
- Any systemic anti-tumor treatment received within the three months prior to participating in the study, including but not limited to intravenous...
- The patient is undergoing approved or under-development systemic anti-cancer therapies, including chemotherapy, biological immunotherapy, targeted...
- The histopathological results show a mixture of liver cancer, squamous cell carcinoma or sarcoma cell components, or ampullary carcinoma.
- Accompanied by other malignant tumors, but having had other uncured malignant tumors in the past (within 5 years) or simultaneously.
- Significant digestive tract diseases: Pre-existing or existing grade 3 or above digestive tract fistula or non-digestive tract fistula as per CTCAE...
See the full eligibility criteria
Who can join
- The people voluntarily participated in the study and agreed to sign the written informed consent, with good compliance and follow-up, and were at least 18 years old at the time of signing the informed consent...
- Patients with advanced biliary carcinoma diagnosed by imaging and histology as unresectable, recurrent, locally advanced, or with metastatic lesions are defined as stage IIIA or above according to the AJCC-8 staging...
- Radical surgery/local treatment, including focal excision, ablation, transcatheter arterial chemoembolization, hepatic arterial infusion chemotherapy, and radiotherapy, is not appropriate for at least 4 weeks prior to...
- Patients were intolerant or failed for ≥1 month after first-line systemic therapy, required palliative care, and patient adverse events were controlled (NCI-CTCAE≤ Grade I).
- At least one measurable lesion (a spiral CT scan of a measurable lesion ≥10mm or an enlarged lymph node ≥15mm, as required by RECIst version 1.1).
- The ECOG score in the first week of enrollment was 0-1. Survival was expected to be ≥3 months as assessed by the investigators.
- Active hepatitis B and C patients are required to receive relevant antiviral therapy, HBV-DNA \< 2000 IU/ml (\< 104 copies /ml), and have received anti-HBV therapy for at least 14 days prior to study entry and continue...
- Hematology and organ function are adequate, based on the following laboratory results obtained within 14 days prior to initiation of investigational therapy (unless otherwise indicated)
- Any clinically significant biliary obstruction should be resolved before randomization.
- Adequate renal function: creatinine ≤1.5×ULN, or creatinine clearance \>50mL/min
- Women who are fertile: agree to abstain from sex (abstain from heterosexual intercourse) or use a contraceptive method with an annual contraceptive failure rate of \< 1% during treatment and for at least 6 months after...
- Men: agree to abstain from sex (no heterosexual intercourse) or use contraception, and agree not to donate sperm.
What rules you out
- Those who have previously received treatment with immune checkpoint inhibitors, lenvatinib or paclitaxel, or are known to be allergic to or intolerant to immune checkpoint inhibitors, lenvatinib or paclitaxel and their...
- Any systemic anti-tumor treatment received within the three months prior to participating in the study, including but not limited to intravenous infusion and/or oral chemotherapy, targeted drugs, antibody drugs and...
- The patient is undergoing approved or under-development systemic anti-cancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or traditional Chinese medicine therapy with clear indications...
- The histopathological results show a mixture of liver cancer, squamous cell carcinoma or sarcoma cell components, or ampullary carcinoma.
- Accompanied by other malignant tumors, but having had other uncured malignant tumors in the past (within 5 years) or simultaneously.
- Significant digestive tract diseases: Pre-existing or existing grade 3 or above digestive tract fistula or non-digestive tract fistula as per CTCAE 5.0 criteria. There is evidence or history of bleeding mechanism...
- Cardiovascular and cerebrovascular diseases with significant clinical significance Including but not limited to having experienced acute myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident...
- Liver and kidney insufficiency: Liver insufficiency: Characterized by jaundice, ascites and/or bilirubin \>3×ULN. Renal insufficiency: Creatinine ratio \>3.5g/24 hours, urine routine showing urine protein ≥++ or...
- Have active autoimmune diseases or a history of autoimmune diseases or are at risk of immune diseases: Have suffered from active, known or suspected autoimmune diseases in the past two years, including but not limited...
- Neurological disorders: Known or untreated brain metastases, or patients with epilepsy requiring drug treatment. Known active central nervous system metastases and/or cancerous meningitis. people with previously treated...
- Infectious disease: Persistent infection with grade \>2 (CTCAE 5.0). A known history of active tuberculosis (Mycobacterium tuberculosis). A known history of human immunodeficiency virus (HIV) infection.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 Beijing, Beijing 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.