Pheochromocytoma/paraganglioma
Conditions
Interventions
one:Anrotinib hydrochloride capsule 12mg QD was taken orally for 2 consecutive weeks and then discontinued for 1 week, with a time interval of > 12h
one:Piamprizumab 200mg intravenously every 3 weeks
Sponsors
Cancer Hospital of Sun Yat-sen
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients voluntarily participate in this study and sign informed consent; (2) Patients aged =18 years and =75 years; (3) ECOG score =2 points; Expected survival =6 months; (4) Pathological diagnosis of advanced pheochromocytoma/paraganglioma: including clinical stage IV inoperable resection, postoperative recurrence or transfer Metastatic pheochromocytoma/paraganglioma; (5) Unwilling or unsuitable for chemotherapy and radionuclide therapy. (6) At least one measurable lesion (RECIST 1.1); (7) The main organs function well, and the laboratory examination indicators meet: Blood routine examination: Hemoglobin (HB) = 90g/L(5.6 mmol/L); Absolute neutrophil count (ANC) =1.5×109/L; Total white blood cells =3.5×109/L; ? Platelet (PLT) = 80×109/L; Blood biochemical examination: ? Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 × ULN (liver metastasis/bone metastasis =5 × ULN; Bone metastases =5 ULN); ? Serum total bilirubin (TBIL) =1.5 × ULN; ? Serum creatinine Cr=1.5×ULN or creatinine clearance =60 ml/min; Blood urea nitrogen (BUN)=2.5 × upper limit of normal value (ULN); ? Albumin (ALB)=30 g/L; Blood clotting test: ? Activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) = 1.5×ULN; ? Women of childbearing age must confirm their non-pregnant status before enrollment, and all enrolled subjects (regardless of male or female) should be treated completely Use adequate contraception during treatment and within 4 weeks after the end of treatment; (3) The subjects voluntarily joined the study and were willing to return to the hospital for follow-up, and the compliance was good; Myocardial enzymes and ejection fraction were normal.
Exclusion criteria
Exclusion criteria: (1) known allergic reactions to anrotinib hydrochloride capsules, piamplizumab active ingredients or any excipients; (2) Receiving anti-tumor monoclonal antibodies or other investigational drugs before enrollment; Previous treatment with other anti-PD-1 monoclonal antibodies or other medications targeting PD-1 / PD-L1; (3) Previous use of anrotinib hydrochloride capsules or other anti-angiogenic drugs, such as Sunitinib, bevacizumab, etc.; (4) Patients were taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (doses greater than 10mg/day prednisone or other equivalent hormones) and were still taking them within 2 weeks prior to enrollment; (5) The patient has any active autoimmune disease or a history of autoimmune disease; Have clinical symptoms or diseases of the heart that are not well controlled; (6) Congenital or acquired immune deficiency; (7) History of gastrointestinal perforation or open biopsy within 4 weeks prior to enrollment; =CTCAE grade 3 for any bleeding event, presence of unhealed wounds, ulcers, or fractures; (8) Hyperarterial/venous thrombosis events occurred within 6 months before the study period, such as non-cardiovascular and cerebrovascular events (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and cured by investigators), pulmonary embolism, etc.; Cardiac angioplasty or coronary bypass surgery for unstable arrhythmia, unstable angina pectoris or myocardial (9) infarction; (10) People with active bleeding or bleeding tendency; (11) Correcting QT interval > 480msec; If a patient has QT interval prolongation, but the cause of the prolongation is assessed by the investigator as a pacemaker (and no other cardiac abnormalities), the patient should be considered suitable for inclusion in the study after discussion with the sponsor study physician; (12) Patients suspected of having other primary cancers; Patients with other primary malignancies within the 5 years prior to the study (other than adequately treated cervical or skin cancer in situ, such as basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer); (13) Complicated diseases/medical history: ? Clinically significant hemoptysis (> 50ml daily hemoptysis) occurred within 3 months prior to enrollment; Or clinically significant bleeding symptoms or Have a definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood or above at baseline, or have vasculitis; (2) hypertension, which is not well controlled by antihypertensive drugs (systolic blood pressure =150 mmHg or diastolic blood pressure =100mmHg); In the 6 months prior to randomization, the following conditions had occurred: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, clinically significant supracentricular or ventricular arrhythmias, and symptomatic congestive heart failure; (3) interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/ L), pulmonary fibrosis and acute pneumonia, etc.); Renal failure requires hemodialysis or peritoneal dialysis; 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 analytical methods) or chronic hepat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Duration of remission;Duration of remission;Overall survival; | — |
Countries
China
Contacts
Public ContactGuo Shengjie
Cancer Hospital of Sun Yat-sen
Outcome results
None listed