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New treatment option for Biliary Tract Neoplasms Immunotherapy
Official title Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07704177
What this study is testing
What is Trastuzumab Rezetecan?
Trastuzumab Rezetecan is an investigational medicine, given as an 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
- An investigation into the survival outcomes, progression-free survival, and safety of triple therapy with Trastuzumab Rezetecan, Adebrelimab, and Lenvatinib in patients with advanced HER2-positive/low-expressing biliary tract cancer after the failure of at least two prior systemic therapies.
- 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 80
You may be able to join if
- The people voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.
- Age: 18 years or above, Gender: Open to al
- Locally advanced or metastatic cholangiocarcinoma confirmed by pathological histology or cytology, including cholangiocarcinoma (intrahepatic...
- Having progressed or experienced intolerance after at least one systemic treatment regimen in the past
- HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2/CEP17 ≥ 2.0), HER2 low expression (IHC 2+/FISH- or IHC 1+)
You likely can't join if
- Histopathological examination confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small...
- Having another active malignant tumor within 5 years or simultaneously, excluding cervical carcinoma in situ that has been fully treated, as well as...
- The adverse reactions from previous anti-tumor treatments have not yet recovered to a NCI-CTCAE v5.0 rating of ≤ 1 (excluding cases of hair loss...
- Any disease evidence determined by the researchers (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, moderate...
- History of severe cardiovascular and cerebrovascular diseases: Within 12 months prior to randomization, there were manifestations of NYHA "grade 3 or...
- The people have congenital or acquired immune system deficiencies (such as HIV-infected individuals); or have a history of organ transplantation.
See the full eligibility criteria
- The people voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.
- Age: 18 years or above, Gender: Open to al
- Locally advanced or metastatic cholangiocarcinoma confirmed by pathological histology or cytology, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer
- Having progressed or experienced intolerance after at least one systemic treatment regimen in the past
- HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2/CEP17 ≥ 2.0), HER2 low expression (IHC 2+/FISH- or IHC 1+)
- There is at least one measurable lesion that meets the requirements of RECIST v1.1.
- The ECOG score is between 0 and 1.
- Expected survival period ≥ 12 weeks
- The organs and bone marrow have sufficient functions and meet the following requirements: (within 14 days before starting the treatment): 1) Blood routine examination: (within 14 days before the screening, no blood...
- For both male participants with fertile female partners and female participants with fertile partners, they must take effective contraceptive measures from the moment they sign the informed consent form until 7 months...
- Histopathological examination confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, mucinous cystic tumor, etc
- Having another active malignant tumor within 5 years or simultaneously, excluding cervical carcinoma in situ that has been fully treated, as well as skin basal cell or squamous cell carcinoma
- The adverse reactions from previous anti-tumor treatments have not yet recovered to a NCI-CTCAE v5.0 rating of ≤ 1 (excluding cases of hair loss, meeting the numerical requirements of the inclusion criteria, or other...
- Any disease evidence determined by the researchers (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, moderate or severe ascites with clinical symptoms; uncontrollable or moderate to...
- History of severe cardiovascular and cerebrovascular diseases: Within 12 months prior to randomization, there were manifestations of NYHA "grade 3 or above" congestive heart failure, unstable angina pectoris, myocardial...
- The people have congenital or acquired immune system deficiencies (such as HIV-infected individuals); or have a history of organ transplantation.
- Those who had active tuberculosis within 1 year prior to enrollment, or those who had a history of active tuberculosis infection more than 1 year ago but did not receive proper treatment.
- The study excluded patients who had a history of gastrointestinal bleeding within 6 months prior to treatment or who had a clear tendency towards gastrointestinal bleeding; patients with known hereditary or acquired...
- Within 4 weeks prior to the start of the treatment, had undergone major surgical procedures (except for biopsy procedures); the surgical incision had not yet fully healed; was expected to undergo major surgical...
- Severe, non-healed or open wounds, active ulcers or untreated fractures
- Previous or current presence of central nervous system metastasis
- The first study: Using attenuated live vaccines within 28 days before the start of the treatment, or it is expected that attenuated live vaccines will be needed during the study treatment period or within 60 days after...
- Patients with active autoimmune diseases, or those who have a history of autoimmune diseases and require long-term use of systemic glucocorticoids (equivalent dose of prednisone ≥ 10 mg/day, for more than 2 weeks) or...
- Based on the researchers' assessment, there are other factors that might have affected the research results or led to the premature termination of this study, such as alcohol abuse, drug addiction, having other serious...
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.