BridgeMD
New treatment option for Biliary Tract Neoplasms Immunotherapy
Official title Pembrolizumab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer
ClinicalTrials.gov ID: NCT06230471
What this study is testing
What is Pembrolizumab,Lenvatinib and Gemox Chemotherapy（Gemcitabine and Oxaliplatin）?
Pembrolizumab,Lenvatinib and Gemox Chemotherapy（Gemcitabine and Oxaliplatin） is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for biliary tract neoplasms immunotherapy.
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
- Explore the impact of the first-line application of Pembrolizumab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 80
You may be able to join if
- The people voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.
- They are over 18 years of age and gender is not restricted when signing the informed consent form.
- They have histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic...
- Patients who are diagnosed with unresectable or metastatic disease and have not received prior treatment are eligible for inclusion.
- Patients who have undergone curative surgery and experienced disease recurrence after more than 6 months; or patients who have completed adjuvant...
You likely can't join if
- Previous systemic treatment received.
- ECOG score \> 1.
- Pancreatic cancer.
- Pregnant (positive pregnancy test before medication) or breastfeeding women.
- Known allergy or intolerance to recombinant humanized PD-1 monoclonal antibody drugs, lenvatinib and its components (or any excipients).
- Received local anti-tumor treatment within 4 weeks before the first study drug treatment, including but not limited to surgery, radiotherapy, hepatic...
See the full eligibility criteria
Who can join
- The people voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.
- They are over 18 years of age and gender is not restricted when signing the informed consent form.
- They have histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
- Patients who are diagnosed with unresectable or metastatic disease and have not received prior treatment are eligible for inclusion.
- Patients who have undergone curative surgery and experienced disease recurrence after more than 6 months; or patients who have completed adjuvant therapy (chemotherapy and/or radiotherapy) and have been disease-free for...
- They have at least one measurable lesion (as defined by RECIST 1.1, the measurable lesion is a spiral CT scan long diameter ≥10mm or lymph node short diameter ≥15mm).
- Their ECOG score is 0-1 in the week prior to enrollment.
- Based on the investigator's assessment, their estimated survival time is ≥3 months.
- Patients with active hepatitis B or C require relevant antiviral treatment, with HBV-DNA \<2000 IU/ml (\<104 copies/ml), and have received at least 14 days of antiviral treatment before participating in the study. HCV...
- Their hematological and organ functions are adequate, based on laboratory test results obtained within 14 days before the start of the study (unless otherwise specified):
- Hematology: (no blood transfusion, no G-CSF, no drug correction within 14 days prior to screening) Hb ≥90 g/L; neutrophil count ≥1.5×109/L; PLT ≥100×109/L.
- Biochemistry: (no albumin transfusion within 14 days) Appropriate liver function: ALT and AST ≤2.5×ULN; for patients with liver metastases, ALT and AST ≤5 × ULN. Serum bilirubin ≤2.0×ULN; these conditions do not apply...
- Women of childbearing potential: agree to abstain from sexual intercourse or use contraceptive methods with a failure rate of less than 1% during the treatment period and for at least 6 months after the last dose. If a...
- Male: agree to abstain from sexual intercourse or use contraceptive measures, agree not to donate sperm, as defined below: When the female partner is of childbearing potential, male patients must abstain during the...
What rules you out
- Previous systemic treatment received.
- ECOG score \> 1.
- Pancreatic cancer.
- Pregnant (positive pregnancy test before medication) or breastfeeding women.
- Known allergy or intolerance to recombinant humanized PD-1 monoclonal antibody drugs, lenvatinib and its components (or any excipients).
- Received local anti-tumor treatment within 4 weeks before the first study drug treatment, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery infusion, radiofrequency...
- Previous or existing grade 3 or higher gastrointestinal fistula or non gastrointestinal fistula (such as skin) according to CTCAE 5.0 criteria. Multiple factors affecting oral administration of lenvatinib (such as...
- Major surgery (except biopsy) has been performed within 4 weeks before the first study drug treatment, or the surgical incision has not completely healed; minor surgery (such as simple excision, biopsy, etc.) was...
- Significant cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, cerebrovascular accidents or transient ischemic attacks within 6 months...
- Persistent infection \> grade 2 (CTCAE 5.0).
- History of thrombotic events (including stroke and/or transient ischemic attacks) within the past 6 months.
- Poorly controlled hypertension (systolic blood pressure \>160mmHg, diastolic blood pressure \>100mmHg) despite treatment with antihypertensive medications. Active autoimmune disease or history of autoimmune disease...
- Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate as long as they are stable (evidence of no progression on...
- Known human immunodeficiency virus (HIV) infection.
- Known active hepatitis B or C infection and not receiving regular treatment.
- During the screening period, HBV DNA ≥2000 IU/ml (or ≥104 copies/ ml) must be reduced to \<2000 IU/ml (or \<104 copies/ml) with entecavir before enrollment. For eligible participants with Anti-HBc (+)/HBsAg (+)/ HBV...
- Severe non-healing wounds, ulcers, or fractures.
- History of substance abuse or any medical, psychological, or social condition that may affect the study, patient compliance, or endanger patient safety.
- Unresolved toxicity of grade \>1 (CTCAE 5.0) caused by any prior treatment/procedure, except for hair loss, anemia, and hypothyroidism.
- Severe non-healing wounds, ulcers, or fractures.
- Objective evidence of severe pulmonary impairment, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-related pneumonia.
- Treatment with a strong CYP3A4 inhibitor (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole, etc.) within 7 days before participating in the study, or...
- Concomitant malignancy, except for previously treated skin basal cell carcinoma, squamous cell carcinoma, carcinoma in situ of the breast or cervix, superficial bladder cancer that has been treated, and prostate cancer...
- The investigator determines that the participant is unsuitable for the study based on overall medical condition.
- Concurrent participation in another clinical study.
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 80 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.