Neuroendocrine Tumor
Conditions
Interventions
Experimental group:Tucidinostat and Surufatinib
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adequately understand the study and voluntarily sign the Informed Consent Form; 2. Aged 18-75 years; 3. Patients have a confirmed histologically pathology diagnosis of well differentiated advanced (unresectable or distant metastatic) NETs: (1) For gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs), G1 is defined as 20/10 HPF and/or > 20% Ki-67 index; (2) For NETs originating from the lung and thymus gland, G1 is defined as = 1.5 x 10^9/L, platelet count >= 100 x 10^9/L, and hemoglobin >= 9 g/dL; Serum total bilirubin < 1.5 times the upper limit of normal (ULN); Patients who do not have liver metastasis, with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels <= 2.5 times the ULN; and who do have liver metastasis, with ALT and AST <= 5 times ULN; Serum creatinine or creatinine < 1.5 times ULN; 7. International Normalized Ratio (INR) <= 1.5 ULN and activated partial thromboplastin time (APTT) <= 1.5 ULN; 8. Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale; 9. Male or females patients with reproductive potential must agree to use an effective contraceptive method, for example, double-barrier device, condom, oral or injected birth control medication or intrauterine device, during the study and within 90 days after study treatment discontinuation. All female patients are considered to be fertile, unless the patient had natural menopause or artificial menopause or sterilization (such as hysterectomy, bilateral oophorectomy or ovarian irradiation); 10. Have expected survival of more than 3 months.
Exclusion criteria
Exclusion criteria: 1. High grade (G3) neuroendocrine cancer, adenocarcinoid, pancreatic islet cell carcinoma, goblet cell carcinoid, large cell neuroendocrine carcinoma and small cell carcinoma; 2. Functional NETs which need to be treated with long acting SSAs to control disease related syndromes, such as insulinoma, gastrinoma, glucagonoma, somatostatinoma, ACTHoma, VIPoma, accompanied by carcinoid syndrome, Zollinger-Ellison syndrome or other active symptoms; 3. Have received anti-VEGF/VEGFR targeted drugs and progressed upon these drugs in 6 months; 4. Have received histone deacetylase inhibitors; 5. Urinalysis shows urine protein >= 2+ or 24-hour protein quantity test shows urinary protein >= 1 g; 6. Serum potassium, calcium (albumin-bound ionic or corrected) or magnesium exceed the normal range with clinical significance; 7. Under anti-hypertension treatment, still uncontrolled hypertension, defined as: systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg; 8. Gastrointestinal disease or condition that investigators suspect may affect drug absorption, including, but not limited to, active gastric and duodenal ulcers, ulcerative colitis and other digestive disease, gastrointestinal tumor with active bleeding, or other gastrointestinal conditions that may cause bleeding or perforation by investigator's discretion; 9. History or presence of a serious hemorrhage (>30 mL within 3 months), hemoptysis (> 5 mL blood within 4 weeks) or a thromboembolic event (including transient ischemic attack) within 12 months; 10. Mean corrected QT interval (QTc) >= 480 msec; 11. Pregnant or lactating female; 12. Any other conditions deemed inappropriate by the investigator to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Maximum tolerated dose;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of remission;Overall survival; | — |
Countries
China
Contacts
Public ContactWei Wang
Sun Yat-sen University Cancer Center
Outcome results
None listed