Pheochromocytoma/paraganglioma
Conditions
Interventions
Test group:Bectumomab 1200mg i.v.gtQ3w
Anlotinib was given orally at a dose of 12 mg for 14 days followed by 7 days off for a course of 21 days
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in this study and signed informed consent. 2. patients aged >=18 and =6 months. 4. Advanced pheochromocytoma/paraganglioma diagnosed by pathology: including clinical stage IV pheochromocytoma/paraganglioma that could not be resected, postoperative recurrence or metastasis; 5. unwilling or not suitable for chemotherapy and radionuclide therapy. 6. at least one measurable lesion (RECIST 1.1); 7. The main organs function was good, and the laboratory examination indicators met: Blood routine examination: (1) Hemoglobin (HB) >= 90g/L(5.6 mmol/L); (2) Absolute neutrophil count (ANC) >=1.5×10^9/L; White blood cell count >=3.5×10^9/L; (3) Platelet (PLT) >= 80×10^9/L; Blood biochemical tests: (1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 ml/min; Blood urea nitrogen (BUN) =30 g/L; Coagulation function tests: (1) Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) <= 1.5×ULN; (2) Women of childbearing age must confirm their non-pregnancy status before enrollment. All enrolled subjects (male or female) should take adequate contraceptive measures during the whole treatment period and for 4 weeks after the end of treatment; (3) Subjects voluntarily participated in this study and were willing to return to the hospital for follow-up, with good compliance; Myocardial enzymes and ejection fraction were normal.
Exclusion criteria
Exclusion criteria: 1. known allergic reaction to anlotinib hydrochloride capsules, the active ingredient of bermosubamab, or any excipients; 2. patients received anti-tumor monoclonal antibodies or other study drugs before enrollment; Prior treatment with other anti-PD-1 monoclonal antibodies or other PD-1 / PD-L1 drugs; 3. previous use of anlotinib hydrochloride capsules or other anti-angiogenic drugs, such as sunitinib, bevacizumab, etc.; 4. patients were receiving immunosuppressive or systemic hormone therapy for immunosuppression (prednisone at a dose greater than 10mg/day or equivalent) within 2 weeks before enrollment; 5. patients with any active autoimmune disease or a history of autoimmune disease; Patients with uncontrolled cardiac symptoms or diseases; 6. patients with congenital or acquired immune deficiency; 7. history of gastrointestinal perforation or open biopsy within 4 weeks before enrollment; Any bleeding events >=CTCAE grade 3, the presence of unhealed wounds, ulcers, or fractures; 8. arterial/venous thrombosis events occurred within 6 months before enrollment, such as non-cardio-cerebrovascular events (including transient ischemic attack), deep vein thrombosis (except venous thrombosis caused by venous catheterization due to previous chemotherapy, which was judged by the investigator to be cured), and pulmonary embolism. "Unstable arrhythmia, due to unstable angina pectoris, or myocardium. 9. Admission for cardiac angioplasty or coronary artery bypass grafting; 10. patients with active bleeding or bleeding tendency; 11. corrected QT interval > 480msec; If a patient had a prolongation of the QT interval that was assessed by the investigator as being due to the pacemaker (and in the absence of other cardiac abnormalities), a decision about enrollment was made after discussion with the sponsor research physician. 12. patients with suspected other primary cancers; Patients with other primary malignancies within 5 years before the study (except adequately treated cervical cancer or skin cancer in situ, such as basal cell carcinoma, squamous cell carcinoma, or nonmelanoma skin cancer); 13. Comorbidities/Medical history: (1) Clinically significant hemoptysis (> 50ml/day) within 3 months before enrollment; Or clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood or above, or angiitis; (2) hypertension that is not well controlled by antihypertensive medication (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100mmHg); Within 6 months before randomization, myocardial infarction, severe or unstable angina, NYHA class 2 or higher cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure occurred; (3) Interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases such as poorly controlled diabetes (fasting blood glucose > 10mmol/ L), pulmonary fibrosis and acute pneumonia; (4) renal failure requiring hemodialysis or peritoneal dialysis; (5) Liver cirrhosis, decompensated liver disease, active hepatitis (hepatitis B, defined as HBV-DNA= 500 IU/ml; Hepatitis C, defined as HCV-RNA above the lower detection limit of the assay) or chronic hepatitis requiring antiviral therapy; (6) vaccination history of live attenuated vaccine within 28 days before the first study medication or expected vaccination during the study period; (7) Human immun
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Duration of response;Overall survival; | — |
Countries
Chian
Contacts
Public ContactGuo Shengjie
Sun Yat-sen University Cancer Center
Outcome results
None listed