Adrenocortical Carcinoma
Conditions
Interventions
Queue A (Increasing)1:Tetrandrine tablets, monotherapy, 40 mg, three times daily, oral administration.
Queue A (Increasing)2:Tetrandrine
Queue A (Expansion):Tetrandrine tablets, monotherapy (dose regimen inferred from phase I)
Queue B (Increasing)2:Tetrandrine tablets, 60 mg, three times daily, oral administration, in combination with mitotane tablets.
Queue B (Expansion):Tetrandrine tablets, oral administration, in combination with mitotane tablets (dose regimen inferred from phase I)
Queue B (Increasing)1:Tetrandrine tablets, 40 mg, three times daily, oral administration, in combination with mitotane tablets.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adrenocortical carcinoma (ACC); 2. Patients with recurrent or metastatic ACC with disease progression after mitotane monotherapy or mitotane-containing combination therapy, or intolerance to current treatment; 3. Age >=18 years and =90 g/L; 2) Absolute neutrophil count (ANC) >=1.5 × 10^9/L; 3) Platelets (PLT) >=75 × 10^9/L; (2) Biochemical parameters: 1) Total bilirubin (TBIL) =60 mL/min; (3) Coagulation parameters: 1) International normalized ratio (INR) or prothrombin time (PT) <=1.5 × ULN; 2) Activated partial thromboplastin time (APTT) <=1.5 × ULN (subjects on anticoagulant therapy should have PT and APTT within the expected therapeutic range); (4) Cardiac parameters: 1) Fridericia-corrected QT interval (QTcF) <450 ms; 8. Males and females of reproductive potential must agree to use medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after the last dose of the study drug; 9. Females of reproductive potential: negative blood pregnancy test within 7 days prior to the first dose of study drug; participants must not be breastfeeding; 10. Disease progression prior to this trial without radiographic confirmation after the use of Hanfangji jiasu tablets; 11. High compliance as judged by the investigator, willingness to complete the study, and ability to follow the study protocol; 12. Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. History of any other malignant tumors in the past 5 years, except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical cancer in situ, and papillary carcinoma of the thyroid; 2. Patients with active (uncontrolled or clinically symptomatic) brain metastasis, carcinomatous meningitis, spinal cord compression, or a history of primary tumors of the central nervous system, or cerebral edema requiring steroids or dehydration intervention; (1) Patients with brain metastases who completed treatment at least 28 days prior to the first use of the study drug and have stable symptoms may be enrolled at the investigator’s discretion, provided cranial imaging (e.g., CT, MRI, or venography) confirms the absence of cerebral hemorrhage; 3. Received cytotoxic drugs, immunotherapy, targeted therapy, or participation in another clinical trial within 10 mg/day) or other immunosuppressive agents within 2 weeks prior to first study drug dose, except for physiological replacement in ACC (postoperative or disease-related) or for local inflammation, allergy prophylaxis, or antiemesis; inhaled or topical steroids and adrenal replacement therapy (>10 mg/day prednisone equivalent) are permitted in the absence of active autoimmune disease; 9. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years; replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement [<10
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of AEs;Serious adverse event;Objective response rate;Median overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactZheng Li
West China Hospital of Sichuan University
Outcome results
None listed