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OncoMatch/Clinical Trials/NCT06587802

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

Is NCT06587802 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Triprolizumab and rodiotherapy for adrenocortical carcinoma.

Phase 2RecruitingSun Yat-sen UniversityNCT06587802Data as of May 2026

Treatment: Triprolizumab · rodiotherapyAdrenal 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: mitotan monotherapy, chemotherapy, or first-line regimens based on mitotan combined with cisplatin chemotherapy (mitotan, cisplatin) — first-line

Adrenal cortical cancer has recurred or metastasized after receiving mitotan monotherapy, chemotherapy, or first-line regimens based on mitotan combined with cisplatin chemotherapy and has progressed, unable to tolerate or unwilling to accept the regimens

Cannot have received: anti-tumor monoclonal antibodies or other investigational drugs

Receiving anti-tumor monoclonal antibodies or other investigational drugs before enrollment

Cannot have received: anti-PD-1 monoclonal antibody therapy or other drug therapy for PD-1 / PD-L1

Previously received other anti-PD-1 monoclonal antibody therapy or other drug therapy for PD-1 / PD-L1

Cannot have received: radiotherapy

Exception: Radiotherapy has been used in the lesion area in the past

Radiotherapy has been used in the lesion area in the past

Lab requirements

Blood counts

Hemoglobin (HB) ≥90g/L; ANC ≥1.5×10^9/L; Total white blood cells ≥3.5×10^9/L; Platelet (PLT) ≥80×10^9/L

Kidney function

Serum creatinine Cr≤1.5×ULN or creatinine clearance ≥60ml/min; Blood urea nitrogen (BUN)≤2.5×ULN

Liver function

ALT and AST ≤2.5×ULN (liver metastasis/bone metastasis ≤5× ULN); Serum total bilirubin (TBIL) ≤1.5×ULN; Albumin (ALB)≥30g/L

The main organs function well, and the laboratory examination indicators meet: (1) Blood routine examination: Hemoglobin (HB) ≥90g/L(5.6mmol/L); Absolute neutrophil count (ANC) ≥1.5×109/L; Total white blood cells ≥3.5×109/L; Platelet (PLT) ≥80×109/L; (2) Blood biochemical examination: ① Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (liver metastasis/bone metastasis ≤5× ULN; Tumor bone metastasis ≤5ULN); ② Serum total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine Cr≤1.5×ULN or creatinine clearance ≥60ml/min; Blood urea nitrogen (BUN)≤2.5× upper limit of normal value (ULN); ④ Albumin (ALB)≥30g/L; (3) Blood coagulation test: Activated partial thromboplastin time (APTT), International Normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN;

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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