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

Launched by SUN YAT-SEN UNIVERSITY · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with recurrent or metastatic adrenal cortical carcinoma, a rare and aggressive type of cancer. The researchers are exploring the combination of a PD-1 antibody, which helps boost the immune system's response to cancer, with radiation therapy, which uses high-energy rays to target and shrink tumors. The goal is to see if this combination can better control the cancer and improve patients' outcomes compared to existing treatments.

To qualify for the study, participants must be at least 18 years old and have a confirmed diagnosis of adrenal cortical carcinoma that has either returned or spread after receiving standard treatments. They should also have at least one measurable tumor and be in good overall health, with no major organ dysfunction. Participants can expect to receive this combined treatment and will be monitored closely for their response. It's important to note that the trial is not yet recruiting participants, so there will be more information available as it progresses.

Gender

ALL

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)