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New treatment option for HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Official title A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
ClinicalTrials.gov ID: NCT06778031
What this study is testing
What is SHR-A1811?
SHR-A1811 is an investigational medicine, being studied as a potential treatment for her2-positive locally advanced or metastatic 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
- This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.
- 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
- Age 18-75 years old (including both ends), male or female;
- ECOG-PS score: 0 or 1;
- Expected survival ≥ 12 weeks;
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
- people who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the...
You likely can't join if
- Other active malignancies within 5 years or at the same time;
- Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
- people with biliary obstruction should be excluded;
- There is active autoimmune disease or a history of autoimmune disease that may recur;
- Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung...
- Severe infection within 4 weeks prior to initiation of study treatment;
See the full eligibility criteria
- Age 18-75 years old (including both ends), male or female;
- ECOG-PS score: 0 or 1;
- Expected survival ≥ 12 weeks;
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
- people who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease...
- According to the RECIST v1.1 standard, the people had at least one measurable lesion;
- The main organ function is normal, in line with the program requirements;
- Consent to contraception.
- Other active malignancies within 5 years or at the same time;
- Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
- people with biliary obstruction should be excluded;
- There is active autoimmune disease or a history of autoimmune disease that may recur;
- Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
- Severe infection within 4 weeks prior to initiation of study treatment;
- Active hepatitis B virus (HBV) infection;
- Have serious cardiovascular and cerebrovascular diseases.
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
- Shanghai, Shanghai 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 Harbin, Heilongjiang, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
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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.