RecruitingPhase 3NCT05789043

Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

140 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — camrelizumab (an immunotherapy), apatinib (a drug that cuts off blood supply to tumors), and temozolomide (a chemotherapy) — as a first-line treatment for advanced acral melanoma. Acral melanoma is a rare type of skin cancer that occurs on the palms, soles, or under nails, and is more common in Asian populations. **You may be eligible if...** - You are 18 or older - You have confirmed acral melanoma that has spread or cannot be surgically removed (stage III/IV) - You have not received any prior systemic cancer treatment for this cancer - Your cancer is measurable on scans - Your overall health status is good (ECOG 0–1) and your organs are functioning well - Your life expectancy is more than 12 weeks **You may NOT be eligible if...** - You are currently receiving other chemotherapy, radiation, or immunotherapy - You have had other cancers (except certain treated skin or cervical cancers) - You have active autoimmune disease - You have significant heart problems - You are pregnant or breastfeeding - You received a live vaccine within 4 weeks before enrollment 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

DRUGcamrelizumab+apatinib+TMZ

camrelizumab 200mg,q2w+apatinib 250mg,qd+TMZ 200mg/m2,day1-5/28

DRUGcamrelizumab+apatinib

camrelizumab 200mg,q2w+apatinib 250mg qd

DRUGcamrelizumab

camrelizumab 200mg,q2w


Locations(1)

Beijing Cancer Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT05789043


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