Actively Recruiting
A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2024-09-19
147
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to observe and evaluate the efficacy and safety of multiple drug combinations in the treatment of advanced esophageal squamous cell carcinoma.
CONDITIONS
Official Title
A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Histologically or cytologically confirmed esophageal squamous cell carcinoma, locally advanced, unresectable, or with local recurrence or distant metastases
- Disease progression or intolerance after first-line chemotherapy or immunotherapy, including certain chemoradiotherapy cases
- Best overall response to first-line immunotherapy is complete response, partial response, or stable disease with progression-free survival of at least 3 months
- At least one measurable lesion by RECIST 1.1 criteria, untreated by local therapy or confirmed progressive after radiotherapy
- Provision of tissue samples for biomarker analysis, preferably newly obtained
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate major organ function as defined by specific blood and biochemical test values
- Left ventricular ejection fraction of at least 50% by Doppler ultrasound
- Women of childbearing age must agree to contraception during and for 6 months after the study; negative pregnancy test within 7 days before recruitment; non-lactating women
- Male subjects must agree to contraception during and for 6 months after the study
- Voluntary participation with signed informed consent and willingness to comply with study and follow-up requirements
You will not qualify if you...
- Active autoimmune disease or history of autoimmune disease, including autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis; hyperthyroidism; vitiligo; asthma requiring medical intervention
- Grade 3 or higher immune-related adverse events during prior treatment
- Recent radiation therapy with unresolved radiation pneumonia or toxicities requiring corticosteroids
- Use of immunosuppressants or systemic hormone therapy exceeding 10 mg/day prednisone equivalent within 2 weeks before enrollment
- Active bleeding in primary esophageal lesions
- Previous treatment with the same type of drugs as in this study (except immune checkpoint inhibitors)
- Conditions affecting oral drug absorption or administration
- Brain metastases within the past 3 months
- Severe or uncontrolled diseases including poorly controlled blood pressure, cardiac conditions, active infections, liver diseases, significant proteinuria
- Unhealed wounds or long-term bone fractures
- Significant bleeding events or bleeding tendencies within 4 weeks before recruitment
- Recent arterial or venous thrombotic events within 6 months
- Tumor invasion of major blood vessels with risk of fatal hemorrhage
- Pregnancy or lactation
- History of other malignancies within 5 years except certain cured cancers
- Psychotropic drug abuse or mental disorders preventing participation
- Participation in other drug clinical trials within 4 weeks
- Any other conditions judged by the investigator to impair safety or study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
F
Feng Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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