Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma

  • STATUS
    Recruiting
  • End date
    Dec 3, 2026
  • participants needed
    40
  • sponsor
    Di Wu
Updated on 3 June 2021

Summary

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.

Description

SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).

Details
Condition Acral Melanoma
Treatment SHR-1210+Apatinib
Clinical Study IdentifierNCT04331093
SponsorDi Wu
Last Modified on3 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 measurable
lesion is spiral CT (Or MRI scan with a long diameter 10mm or an enlarged
lymph node with a short diameter 15mm), patients with metastasis can also be
enrolled; 3. Have not received any anti-tumor medication before. 4. ECOG score
is 0 or 1. 5. Tumor tissue specimens must be provided for genetic testing
(preoperative biopsy / intraoperative tissue removal)
\. Expected survival time 12 weeks. 7. The level of organ function must meet
the following requirements (7 days before randomization)
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); . International normalized ratio (INR) and activated partial thromboplastin time (APTT) 1.5 ULN (only applicable to patients who have not received anticoagulant therapy and received anticoagulant therapy, and anticoagulant drugs should meet the treatment requirements)
Cardiac function is normal, that is, the result of ECG is normal or has no
clinical significance. Left ventricular ejection fraction (LVEF) of cardiac
ultrasound examination is> 50%
\. Women of childbearing age must have a negative pregnancy test within 7
days before treatment; males of reproductive capacity or women who are at risk
of pregnancy must use effective contraception throughout the study period and
continue contraception for 3 months after the end of treatment
\. Can swallow pills normally. 10. Voluntarily participate in the research
and sign the informed consent form, with good compliance and willingness to
cooperate with the follow-up

Exclusion Criteria

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
In the case of HBsAg or HBcAb positive, additional HBVDNA testing (results
above the lower limit of detection specified by the study site)
In the case of HCV antibody positive, perform additional HCVRNA detection
\. 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
Have autoimmune disease, or have a history of autoimmune disease or a
syndrome requiring systemic treatment with steroids / immunosuppressants, such
as pituitary inflammation, pneumonia, colitis, hepatitis, nephritis
hyperthyroidism and thyroid Hypofunction
The following occurred within the first 6 months of randomization: 1) deep
vein thrombosis or pulmonary embolism; 2) percutaneous coronary intervention
acute coronary syndrome, coronary artery bypass grafting; 3) cerebrovascular
accident, Transient ischemic attack
Other serious and uncontrolled companion diseases that may affect the
compliance of the agreement or the interpretation of the results, including
active opportunistic or progressive (severe) infection, uncontrolled diabetes
cardiovascular disease (graded by the New York Heart Association) System-
defined grade III or IV heart failure, grade II heart block, myocardial
infarction in the past 6 months, unstable arrhythmia or unstable angina
cerebral infarction in the past three months, etc.). Or lung disease (history
of interstitial pneumonia, obstructive pulmonary disease, and symptomatic
bronchospasm)
\. 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
investigators
\. Other conditions that the researchers consider to be non-compliant or not
applicable to participation
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