Health TrialsbyHealthPanel

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

ConditionAcral Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDi Wu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 applicable to patients who have not received anticoagulant therapy and received anticoagulant therapy, and anticoagulant drugs should meet the treatment requirements);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-1210+Apatinib

    Drug

    Drug: SHR-1210 SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg Drug: Apatinib Apatinib tablet will be administered orally,once daily until progression

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: resectable stage III-IV Acral melanomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pCR

Pathological complete response rate

Time frame
3 months

Secondary outcomes

1

npCR

Near pathological complete response rate

Time frame
3 months
2

ORR

Objective response rate

Time frame
3 months
3

3 Year RFS

Recurrence free survival in 3 years

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Di Wu

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov
Apply now