Actively Recruiting
Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma
Led by National Taiwan University Hospital · Updated on 2024-12-02
35
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma.
CONDITIONS
Official Title
Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older who can understand and provide written informed consent
- Histologically confirmed esophageal squamous cell carcinoma
- Advanced ESCC that is unresectable locally advanced, recurrent, or metastatic, with prior failure of platinum-based chemotherapy and anti-PD-1/PD-L1 therapy
- Measurable disease by RECIST 1.1, excluding stable lesions in previously irradiated areas unless progressed
- ECOG performance status of 0 or 1
- Availability of archival tumor tissue for Trop-2 expression and optional fresh biopsy
- Adequate blood counts without recent transfusion or growth factor support
- Adequate liver function with bilirubin, AST, ALT, and albumin within specified limits
- Creatinine clearance of at least 30 mL/min
- Use of protocol-specified contraception methods for males and females of childbearing potential
- Willingness and ability to comply with study requirements and restrictions
You will not qualify if you...
- Positive pregnancy test or breastfeeding women
- Known allergy or hypersensitivity to sacituzumab govitecan or its components
- Need for ongoing or recent use of prohibited medications
- Recent anticancer biologic therapy within 4 weeks or chemotherapy, targeted therapy, or radiation within 2 weeks without recovery from adverse events
- Not recovered from prior treatment adverse events, except neuropathy or alopecia
- Prior treatment with topoisomerase 1 inhibitors
- Active second cancers, except certain surgically cured or low-risk tumors
- Active inflammatory bowel disease or recent gastrointestinal perforation
- Active serious infection requiring antibiotics
- Known HIV infection with detectable viral load or interference with study drug metabolism
- Active hepatitis B or C infection with detectable viral load
- Concurrent medical or psychiatric conditions that could interfere with study participation
- Any medical condition posing undue risk as judged by investigators
- Use of other investigational drugs within 28 days or 5 half-lives before study drug
- No adequate tumor tissue available for Trop-2 testing
- Active central nervous system metastases
- Adenocarcinoma of the esophagus or gastroesophageal junction
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
C
Chih-Hung Hsu, M.D., Ph.D.
CONTACT
J
Jhe-Cyuan Guo, M.D., Ph.D.
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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