Combining PD-1 antibody with radiotherapy for advanced adrenal cancer

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

This study is testing if a new treatment that combines a PD-1 antibody with radiotherapy can help adults with advanced adrenal cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, prednisone, immunotherapy, Sunitinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06587802 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of combining a PD-1 antibody, Triprolizumab, with radiotherapy in patients with recurrent or metastatic adrenal cortical carcinoma (ACC). Given the aggressive nature of ACC and the limited effectiveness of current treatment options, this study aims to explore a novel therapeutic approach that may improve patient outcomes. Eligible participants include adults with a confirmed diagnosis of ACC who have not responded to previous treatments. The study will assess the safety and effectiveness of this combination therapy in managing the disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recurrent or metastatic adrenal cortical carcinoma who have previously undergone treatment but have not achieved satisfactory results.

Not a fit: Patients who have not been diagnosed with adrenal cortical carcinoma or those who are not eligible for further treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that improves survival rates and quality of life for patients with advanced adrenal cortical carcinoma.

How similar studies have performed: Previous studies have explored immunotherapy for adrenal cortical carcinoma, but this specific combination of PD-1 antibody and radiotherapy is a novel approach.

Eligibility criteria

Inclusion Criteria:

* Patients voluntarily participated in this study and signed informed consent;
* Patients ≥18 years old;
* ECOG score ≤2 points; Expected survival ≥6 months;
* Pathological diagnosis of adrenal cortical carcinoma;
* Inability or unwillingness to surgically resect recurrent or metastatic adrenal cortical cancer;
* 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;
* Have at least one measurable lesion (RECIST1.1);
* 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;
* Women of childbearing age must confirm their non-pregnant status before enrollment, and all enrolled subjects (whether male or female) should take adequate contraceptive measures during the whole treatment period and 4 weeks after the end of treatment;
* The subjects were willing to return to the hospital for follow-up and had good compliance.

Exclusion Criteria:

* Receiving anti-tumor monoclonal antibodies or other investigational drugs before enrollment
* Previously received other anti-PD-1 monoclonal antibody therapy or other drug therapy for PD-1 / PD-L1
* Radiotherapy has been used in the lesion area in the past
* The lesion invades the intestinal duct, and there are contraindications to radiotherapy such as the risk of intestinal fistula caused by radiotherapy
* Known allergic reaction to the active ingredient of PD-1 monoclonal antibody or any excipients
* Have a medical condition that interferes with oral medication, including but not limited to difficulty swallowing, chronic diarrhea, or intestinal obstruction
* Uncontrolled heart disease, such as heart failure with NYHA rating ≥2, unstable angina pectoris, history of myocardial infarction in the past year, and ventricular or supraventricular arrhythmias requiring treatment
* Central nervous system metastasis with clinical symptoms, such as brain edema, requiring hormonal intervention, or brain metastasis progression;
* Serious infections (CTCAE \> Grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging examination indicating active lung inflammation, signs and symptoms of infection within 2 weeks prior to first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use)
* Receive systemic sex hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone/day within 4 weeks of signing the informed consent. Participants with a systemic sex hormone dose ≤10mg prednisone/day or inhaled/topical corticosteroids could be enrolled
* chronic hepatitis B active stage or active hepatitis C patients. Screening period hepatitis B surface antigen (HepatitsBSurfaceAntigen, HBsAg) or hepatitis b core antibody (HBcAb HepatitsBcoreAntibody,) or hepatitis c virus (HepatitisCVirus, HCV) antibody positive patients, Only through HepatitisBVirus (HBV) DNA detection (no more than 104 copies /mL or 2000IU/mL) and HCVRNA detection (no more than the lower limit of the assay) will he be included in the group test after the disease has been controlled. Hepatitis B virus carriers, hepatitis B whose disease has been controlled after drug treatment (no more than 104 copies /mL of DNA or 2000IU/mL), and cured hepatitis C patients can be enrolled
* Significant vital organ dysfunction or uncontrollable comorbiditions, including but not limited to uncontrolled hypertension, decompensated cirrhosis, active peptic ulcer or bleeding disease
* History of interstitial lung disease or non-infectious pneumonia; Participants with a history of drug-induced or radiation-induced non-infectious pneumonia without symptoms were admitted
* Pregnant and lactating women and subjects of childbearing age who do not want to take contraceptive measures
* Persons with mental illness, a history of alcohol or drug abuse, or inability to obtain informed consent
* Other researchers have determined that participants are not suitable for this study, such as serious diseases, including mental illness, serious abnormal test results, and other social or family high-risk risk factors that require timely intervention
* refuse or can not sign the informed consent.
* Patients suspected of having other primary cancers; Patients with other primary malignancies within the 5 years prior to the study period (other than adequately treated cervical or skin cancer in situ, such as basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer)

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Shengjie Guo, doctor

Conditions Adrenocortical Carcinoma; radiotherapy; immunotherapy