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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 as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07670273
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
- This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR).
- 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 HER2-positive people voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.
- Age ≥ 18 years old, gender not limited;
- Locally advanced or metastatic cholangiocarcinoma, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma)...
- Not suitable for radical surgical resection or local treatment. people who have not received any systemic anti-tumor therapy in the past; allowed to...
- 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
- Histological or cytological pathology confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma...
- Having another active malignant tumor within 5 years or simultaneously; excluding cervical carcinoma in situ that has been fully treated, as well as...
- Participants who have previously received immunotherapy, HER2-targeted, or ADC drug treatment, including immune checkpoint inhibitors (such 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...
See the full eligibility criteria
Who can join
- The HER2-positive people voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.
- Age ≥ 18 years old, gender not limited;
- Locally advanced or metastatic cholangiocarcinoma, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer, which has been confirmed by pathological...
- Not suitable for radical surgical resection or local treatment. people who have not received any systemic anti-tumor therapy in the past; allowed to have received radical treatment previously (including surgical...
- 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 people with fertile partners and female people with fertile partners, they must take effective contraceptive measures from the moment they sign the informed consent form until 7 months after the last...
What rules you out
- Histological or cytological pathology confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, mucinous cystic...
- Having another active malignant tumor within 5 years or simultaneously; excluding cervical carcinoma in situ that has been fully treated, as well as basal cell or squamous cell carcinomas of the skin.
- Participants who have previously received immunotherapy, HER2-targeted, or ADC drug treatment, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies...
- 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 one year prior to enrollment, or those who had a history of active tuberculosis infection more than one year ago but did not receive proper treatment.
- The study excluded those who had a history of gastrointestinal bleeding within 6 months prior to treatment or who had a clear tendency towards gastrointestinal bleeding; those with known hereditary or acquired bleeding...
- Within 4 weeks prior to the start of the treatment, if one has undergone major surgical procedures (except for biopsy procedures); if the surgical incision has not fully healed; if major surgical treatment is expected...
- Severe, non-healed or open wounds, active ulcers or untreated fractures;
- Previous or current presence of central nervous system metastasis;
- The first study requires that the people use attenuated live vaccines within 28 days before the start of the treatment, or that they are expected to use attenuated live vaccines during the study treatment period or...
- Patients with active autoimmune diseases, or those with a history of autoimmune diseases and who 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 abuse, having other serious...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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, 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.