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New treatment option for Acral Melanoma
Official title Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma
ClinicalTrials.gov ID: NCT04331093
What this study is testing
What is SHR-1210+Apatinib?
SHR-1210+Apatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acral melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1.18 to 75 years. 2. Clinically diagnosed or pathologically diagnosed, resectable stage III-IV Acral melanoma with at least one measurable lesion...
- Peripheral blood: absolute neutrophil count (≥) 1.5 × 109 / L, platelet count (≥) 100 × 109 // L, hemoglobin (Hb) ≥9g / dL (no blood transfusion...
- Liver: serum total bilirubin (≤) 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (or AST, ALT ≤ 5 × ULN);
- Serum creatinine ≤1.5 × ULN or endogenous creatinine clearance ≥50mL / min (using Cockcroft-Gault formula); ④. International normalized ratio (INR)...
You likely can't join if
- Patients who have been treated with anti-PD-1, anti-PD-L1, VEGFRTKI;
- Patients who are participating or are participating in clinical studies of other drugs or treatments, within 4 weeks before enrollment (prior to...
- Patients who received major surgery, vaccines, and systemic hormone therapy within 4 weeks before the study began; and patients who received...
- In the past 3 years, other malignancies other than acral or mucosal melanoma, except for cured skin basal cell carcinoma, skin squamous cell...
- Receive hematopoietic stimulating factors (such as granulocyte colony stimulating factor (G-CSF) and erythropoietin) within 1 week before the start...
- HIV positive test;
See the full eligibility criteria
- 1.18 to 75 years. 2. Clinically diagnosed or pathologically diagnosed, resectable stage III-IV Acral melanoma with at least one measurable lesion that has not been treated locally (according to RECISTv1.1, this...
- Peripheral blood: absolute neutrophil count (≥) 1.5 × 109 / L, platelet count (≥) 100 × 109 // L, hemoglobin (Hb) ≥9g / dL (no blood transfusion within 14 days before detection);
- Liver: serum total bilirubin (≤) 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (or AST, ALT ≤ 5 × ULN);
- Serum creatinine ≤1.5 × ULN or endogenous creatinine clearance ≥50mL / min (using Cockcroft-Gault formula); ④. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (only...
- Patients who have been treated with anti-PD-1, anti-PD-L1, VEGFRTKI;
- Patients who are participating or are participating in clinical studies of other drugs or treatments, within 4 weeks before enrollment (prior to randomization);
- Patients who received major surgery, vaccines, and systemic hormone therapy within 4 weeks before the study began; and patients who received radiation therapy within 2 weeks;
- In the past 3 years, other malignancies other than acral or mucosal melanoma, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, early prostate cancer and cervical cancer;
- Receive hematopoietic stimulating factors (such as granulocyte colony stimulating factor (G-CSF) and erythropoietin) within 1 week before the start of the study.
- HIV positive test;
- Patients with active hepatitis B or C: ①. In the case of HBsAg or HBcAb positive, additional HBVDNA testing (results above the lower limit of detection specified by the study site). ②. In the case of HCV antibody...
- Urine routine indicates urinary protein ≥ ++ and it has been confirmed that the amount of urinary protein in 24 hours is\> 1.0g;
- Suffering from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Pleural effusion or ascites with clinical symptoms and symptomatic treatment;
- People with ocular shape and central nervous system (CNS) metastasis;
- Have a history of active tuberculosis;
- Have any uncontrollable clinical problems, including but not limited to: ①. Have autoimmune disease, or have a history of autoimmune disease or a syndrome requiring systemic treatment with steroids / immunosuppressants...
- Patients with any condition that affects swallowing the drug, and any condition that affects the absorption of the research product in vivo, including any type of gastrointestinal resection or surgery;
- Previous stem cell transplant or organ transplant;
- Women with childbearing potential or pregnant or lactating women with a positive serum or urine pregnancy test within 7 days before the start of treatment;
- Previously addicted to antipsychotic drugs, cannot be quit, or have a history of mental illness;
- Other serious, acute or chronic medical conditions or laboratory abnormalities may increase the risks associated with participating in the research or may interfere with the interpretation of the research results by...
- Other conditions that the researchers consider to be non-compliant or not applicable to participation.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.