BridgeMD
New treatment option for Adrenocortical Carcinoma
Official title Phase II Study of PD-1 Antibody Combined With Radiotherapy in Recurrent or Metastatic Adrenal Cortical Carcinoma
ClinicalTrials.gov ID: NCT06587802
What this study is testing
What is Triprolizumab?
Triprolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adrenocortical carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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%.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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...
See the full eligibility 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...
- 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 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...
- Women of childbearing age must confirm their non-pregnant status before enrollment, and all enrolled people (whether male or female) should take adequate contraceptive measures during the whole treatment period and 4...
- The people were willing to return to the hospital for follow-up and had good compliance.
- 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...
- 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...
- 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...
- 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 people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.