RecruitingPhase 2NCT04318730

Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma

Sponsor

West China Hospital

Enrollment

21 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

Adrenocortical Carcinoma

Summary

Adrenocortical carcinoma (ACC) is a rare aggressive malignant tumor. According to the literature, the 5-year survival rate of ACC is 12%-47%. For patients with advanced ACC, mitotane alone or combined with traditional chemotherapy was the first-line standard treatment, but its progression-free survival was only about 1 year. However, for patients who fail the first-line treatment, there is a lack of effective treatment. For ACC patients who had failed first-line chemotherapy, a phase II clinical trial found that the objective response rate and the disease control rate of PD-1 inhibitor Keytruda were 14% and 64% respectively, and no grade 3 or 4 adverse events were observed. Anti-tumor angiogenic drugs combined with PD-1 inhibitors have shown impressive clinical data in many solid tumors. This study is aimed to evaluate the efficacy and safety of PD-1 inhibitor camrelizumab combined with apatinib in patients with recurrent or metastatic ACC after standard treatment failure, and to seek new treatment for this population.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — camrelizumab (an immunotherapy that removes brakes on the immune system) and apatinib (a drug that cuts off blood supply to tumors) — as a second-line treatment for adrenocortical carcinoma (cancer of the adrenal glands) that has come back or spread after standard treatment. **You may be eligible if...** - You are at least 18 years old - You have a confirmed diagnosis of adrenocortical carcinoma - Your cancer is metastatic or cannot be surgically removed and has progressed after first-line treatment (mitotane, chemotherapy, or both) - You are in good physical condition (ECOG performance status 0 or 1) - You have at least one measurable tumor on imaging - Your blood counts, organ function, and heart function meet minimum requirements **You may NOT be eligible if...** - You have not yet tried first-line treatment - You have active brain metastases with symptoms - You have active autoimmune disease or are on immune-suppressing medications - You are pregnant or breastfeeding - You have serious heart problems 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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