Actively Recruiting
Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma
Led by Di Wu · Updated on 2021-05-26
40
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acral melanoma is a melanoma that affects acral areas of the skin, which is the most prevalent site of melanoma in non-Caucasians.Data in this subgroup is scarce.This study is to evalueate the efficiency and safety of Neoadjuvant SHR-1210 plus apatinib in this particular group,menawhile to determine the predictive value for efficiency of several biomarkers.
CONDITIONS
Official Title
Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Clinically or pathologically diagnosed resectable stage III-IV acral melanoma with at least one measurable lesion
- No previous local treatment of the measurable lesion
- No prior anti-tumor medication received
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Provide tumor tissue specimens for genetic testing
- Expected survival time of at least 12 weeks
- Organ function within required limits including blood counts, liver and kidney function, coagulation, and normal cardiac function
- Negative pregnancy test for women of childbearing age within 7 days before treatment
- Use of effective contraception during the study and for 3 months after treatment for men and women at risk of pregnancy
- Ability to swallow pills normally
- Voluntary participation with signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, or VEGFR tyrosine kinase inhibitors
- Participation in other clinical drug studies within 4 weeks before enrollment
- Major surgery, vaccines, or systemic hormone therapy within 4 weeks before study start; radiation therapy within 2 weeks
- Other malignancies within past 3 years except certain cured skin and early cancers
- Use of hematopoietic stimulating factors within 1 week before study
- Positive HIV test
- Active hepatitis B or C infection
- Significant proteinuria confirmed by 24-hour urine test
- Uncontrolled high blood pressure
- Symptomatic pleural effusion or ascites
- Ocular or central nervous system metastases
- History of active tuberculosis
- Autoimmune diseases or history requiring systemic immunosuppressive treatment
- Serious recent cardiovascular events or uncontrolled medical conditions
- Conditions affecting drug swallowing or absorption
- Previous stem cell or organ transplant
- Pregnancy or lactation with positive pregnancy test within 7 days before treatment
- History of addiction to antipsychotic drugs or mental illness
- Other serious medical conditions or laboratory abnormalities increasing risk or affecting study results
- Any condition deemed by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The first hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
Research Team
D
Di Wu, MD
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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