RecruitingPhase 2NCT06587802

Phase II Study of PD-1 Antibody Combined With Radiotherapy in Recurrent or Metastatic Adrenal Cortical Carcinoma


Sponsor

Sun Yat-sen University

Enrollment

18 participants

Start Date

Mar 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Adrenal cortical cancer is an extremely rare and highly aggressive malignancy with an incidence of 0.7-2 per million people · year and a 5-year overall survival rate of 15-44%, among which the 5-year survival rate of stage IV cortical cancer is only 13% and the prognosis is poor. Complete surgical resection is one of the most important ways to cure cortical cancer, but the surgical trauma is large, the complications are high, the postoperative recovery of patients is slow, and the tumor is difficult to achieve complete resection, and the postoperative recurrence and metastasis rate of patients is high, even for localized cortical cancer (stage I-III), the recurrence and metastasis rate is still close to 60%. Recurrent or metastatic cortical cancer is mainly treated with drugs. However, the current first-line drug therapy is only 22.3% effective, the tumor progression-free time is 5.6 months, and the serious adverse reaction rate is as high as 58.1%. The effective rate of second-line treatment with chemotherapy and targeted drugs was less than 10%, and the tumor progression-free time was only 2.8 months. The Phase II study of PD-1 monoclonal antibody in the treatment of cortical cancer showed that the treatment effective rate was 23%, and the tumor progression-free survival time was 2.1 months, which was comparable to the first-line regimen, and has been approved by the guidelines for advanced cortical cancer. Radiation therapy has high efficiency and local control rate, small side effects, and can inhibit tumor growth, relieve local pressure and pain. However, it only has a good effect on the irradiated site, and it is difficult to inhibit the progression of non-radiotherapy lesions and the generation of other new lesions. The synergistic effect of immunotherapy combined with radiation therapy for metastatic stoves has been confirmed in many solid tumors such as kidney cancer, which can improve the local control rate of solid tumors and prolong the time of tumor progressive-free. In the early stage, this research team applied PD-1 monoclonal antibody combined with radiotherapy to treat recurrent or metastatic adrenal cortical cancer in many cases after receiving first-line drug therapy regimen, which not only achieved local control of the radiotherapy focus, but also inhibited the progression of other metastases, and achieved longer disease control effect.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a PD-1 immunotherapy drug (which activates the immune system to fight cancer) with radiation therapy can improve outcomes in patients with recurrent or metastatic adrenal cortical carcinoma — a rare and aggressive cancer of the adrenal glands — that cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of adrenal cortical carcinoma (confirmed by pathology) - Your cancer has come back or spread after prior treatment - Surgery to remove the recurrent or metastatic cancer is not possible or you are not willing to undergo surgery - Your overall health is rated 0–2 on standard performance scales and expected survival is at least 6 months **You may NOT be eligible if...** - You have uncontrolled active infections - You have active autoimmune conditions requiring systemic treatment - You have had prior immunotherapy (anti-PD1/PD-L1) for this cancer - You are pregnant or breastfeeding - You have severe organ dysfunction 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

DRUGTriprolizumab

At the end of radiotherapy, 240mg of triplizumab was administered intravenously every cycle (21 days)

DEVICErodiotherapy

SBRT radiotherapy (radiotherapy dose: 40Gy, 5 times, 8Gy each time, number of metastatic radiotherapy: ≤5)


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06587802


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