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Recruiting NCT06778031

A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Phase II Interventional HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-A1811, SHR-1316, SHR-8068.
Who it may be relevant to
Registry conditions: HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Overview

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.

Interventions

  • Drug SHR-A1811
    SHR-A1811.
  • Drug SHR-1316
    SHR-1316.
  • Drug SHR-8068
    SHR-8068.

Primary outcome measures

  • Objective response rate (ORR) of the SHR-A1811 combination evaluated by investigators [Time frame: Screening up to study completion, an average of 3 year.]
Secondary outcome measures (5)
  • Duration of response (DoR) of the SHR-A1811 combination evaluated by investigators [Time frame: Screening up to study completion, an average of 3 year.]
  • Disease control rate (DCR) of the SHR-A1811 combination evaluated by investigators [Time frame: Screening up to study completion, an average of 3 year.]
  • Progression free survival (PFS) of the SHR-A1811 combination evaluated by investigators [Time frame: Screening up to study completion, an average of 3 year.]
  • Overall survival (OS) of the SHR-A1811 combination evaluated by investigators [Time frame: Screening up to study completion, an average of 3 year.]
  • Adverse events (AEs) [Time frame: Screening up to study completion, an average of 3 year.]

Eligibility criteria

Inclusion 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;
  • Subjects 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 recurrence;
  • According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
  • The main organ function is normal, in line with the program requirements;
  • Consent to contraception.

Exclusion criteria

  • Other active malignancies within 5 years or at the same time;
  • Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
  • Subjects 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Affiliated Cancer Hospital of Harbin Medical University — Harbin
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06778031 · SHR-A1811-215

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗