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New treatment option for Biliary Tract Cancer
Official title Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07636798
What this study is testing
What is HAIC Combined Regimen Treatment Group?
HAIC Combined Regimen Treatment Group is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract 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
- Advanced biliary tract cancer has a poor prognosis and limited efficacy with current regimens. This multicenter single-arm phase Ib/II trial explores the efficacy and safety of HAI-GP chemotherapy combined with intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable 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
- Patients must meet all of the following
- Age between 18 years and [missing value] years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed biliary tract carcinoma, deemed unsuitable for radical surgical resection.
- At least one measurable lesion as determined by the investigator in accordance with mRECIST or RECIST version 1.1.
You likely can't join if
- Patients meeting any of the following criteria will be excluded:
- Known hypersensitivity to the investigational drug(s).
- Current participation in another treatment clinical trial, or receipt of any investigational drug or use of investigational device within 4 weeks...
- History of malignancy outside the biliary tract within 5 years prior to first dosing, except for adequately treated basal cell carcinoma of the skin...
- Previous treatment with immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or...
- History of solid organ or hematopoietic stem cell transplantation.
See the full eligibility criteria
Who can join
- Patients must meet all of the following
- Age between 18 years and [missing value] years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed biliary tract carcinoma, deemed unsuitable for radical surgical resection.
- At least one measurable lesion as determined by the investigator in accordance with mRECIST or RECIST version 1.1.
- Estimated life expectancy greater than 3 months.
- No prior systemic therapy or local anti-tumor treatment, except for surgery (biliary drainage is permitted).
- Patients who experience relapse more than 6 months after completion of postoperative adjuvant therapy may be enrolled.
- Child-Pugh score of [missing value] points.
- Adequate organ function to meet the criteria for chemotherapy:
- Bone marrow function: absolute neutrophil count ≥ [missing value]/L; platelet count ≥ [missing value]; hemoglobin ≥ [missing value];
- Hepatic function: total bilirubin ≤ [missing value] × upper limit of normal (ULN); for patients without liver metastases, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ [missing value] × ULN; for...
- Renal function: serum creatinine ≤ [missing value] × ULN; routine urinalysis showing urinary protein \< [missing value]; if baseline urinary protein is [missing value], a 24-hour urine collection must confirm total...
- Coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; for patients receiving anticoagulant therapy, PT must be within the therapeutic range intended for the anticoagulant used.
- Female patients must be postmenopausal or, if premenopausal, have a negative urine or serum pregnancy test; male patients must agree to use effective contraception or have undergone surgical sterilization during the...
What rules you out
- Patients meeting any of the following criteria will be excluded:
- Known hypersensitivity to the investigational drug(s).
- Current participation in another treatment clinical trial, or receipt of any investigational drug or use of investigational device within 4 weeks prior to first dosing.
- History of malignancy outside the biliary tract within 5 years prior to first dosing, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that...
- Previous treatment with immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
- History of solid organ or hematopoietic stem cell transplantation.
- Any condition requiring systemic corticosteroids (equivalent to prednisone or above) or other immunosuppressive therapy within 14 days prior to randomization.
- Active autoimmune disease or history of autoimmune disease with potential for recurrence.
- Radiographic evidence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or prior noninfectious pneumonitis identified on screening chest computed tomography (CT).
- Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia.
- Severe chronic or active infection (including tuberculosis) requiring systemic (oral or intravenous) antibiotic therapy within 14 days prior to randomization.
- Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV-1/2 antibody positive); untreated active Hepatitis B. \ Note: people with Hepatitis B meeting the following criteria are eligible: HBV viral load...
- Concurrent participation in another therapeutic clinical trial.
- Presence of obstructive jaundice (enrollment permitted following active intervention such as biliary drainage or stenting and subsequent normalization of liver function).
- Meeting any of the following cardiovascular criteria:
- New York Heart Association (NYHA) Class II or higher heart failure within 3 months prior to initiation of study treatment;
- Major cardiovascular events including myocarditis, myocardial infarction, cerebrovascular events, unstable arrhythmia, or unstable angina within 6 months prior to initiation of study treatment;
- Symptomatic pulmonary embolism within [missing value] months prior to randomization;
- Known artery disease or left ventricular ejection fraction (LVEF) \< 40%.
- Lactating women.
- Women of childbearing potential unwilling to use contraception.
- Vulnerable populations other than elderly or illiterate individuals, including those with mental illness, cognitive impairment, or critical illness.
- Any other reason deemed by the investigator to render the subject unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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 Chengdu, Sichuan, 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.