RecruitingPhase 2NCT04331093

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

A Single-cencer,Phase II Study of Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma


Sponsor

Di Wu

Enrollment

40 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — SHR-1210 (an immunotherapy drug that activates the immune system) and apatinib (a drug that blocks blood vessel growth in tumors) — given before surgery in people with a specific type of skin cancer called acral melanoma (occurring on the palms, soles, or under the nails) at an advanced but still potentially operable stage. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with acral melanoma at stage III or IV that can potentially be removed by surgery - You have at least one tumor that can be measured on a scan - You have not received any prior anti-cancer treatment for this condition - You are in good physical condition (ECOG 0–1) - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - You have already received any anti-tumor treatment - Your tumor cannot be measured or is not resectable - Your heart, liver, or kidney function does not meet study requirements - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-1210+Apatinib

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


Locations(1)

The first hospital of Jilin University

Changchun, Jilin, China

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NCT04331093


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