Actively Recruiting
Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy
Led by Xiujuan Qu · Updated on 2026-04-01
20
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
his single-center phase II clinical study enrolls patients with unresectable locally advanced or metastatic HER2-overexpressing biliary tract cancer or urothelial carcinoma who have failed standard treatment. Participants receive trastuzumab in combination with serplulimab and chemotherapy. The study aims to evaluate the efficacy and safety of this regimen in this patient population. The primary endpoint is objective response rate (ORR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety.
CONDITIONS
Official Title
Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female.
- Histologically or cytologically confirmed recurrent and/or metastatic advanced biliary tract cancer or urothelial carcinoma.
- Disease progression after at least one prior line of systemic antitumor therapy.
- HER2 overexpression confirmed by immunohistochemistry 3+ or 2+ with in situ hybridization positive.
- Left ventricular ejection fraction 50% or greater.
- No prior anti-HER2 therapy.
- At least one measurable lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Adequate organ reserve function including urine protein 1+ or less and albumin greater than 2.7 g/dL.
- Life expectancy of at least 3 months as judged by the investigator.
- Ability to provide written informed consent and comply with study requirements.
- Female patients of childbearing potential must agree to use highly effective contraception during treatment and for 12 weeks after last dose; male patients must agree to use highly effective contraception during treatment and for 6 months after last dose.
You will not qualify if you...
- Known HER2-negative or HER2-low expression.
- Active autoimmune disease or history of autoimmune disease with potential for relapse.
- Presence of other malignancies within the past 2 years or currently, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 14 days prior to enrollment.
- Weight loss of 20% or more within 2 months prior to enrollment.
- Untreated chronic hepatitis B or active hepatitis C infection.
- Known allergy to any study drug or excipient.
- Palliative radiotherapy within 14 days prior to enrollment.
- Prior anti-HER2 therapy.
- Major surgery within 28 days prior to enrollment, except for minimally invasive procedures such as PICC placement.
- Any underlying medical condition or substance abuse that may interfere with study treatment or safety assessments.
- Concurrent participation in another therapeutic clinical study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
X
Xiujuan Qu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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