gastrointestinal pancreatic neuroendocrine carcinoma
Conditions
Interventions
Combination therapy group:surufatinib combined with HIAC(mFOLFOX)
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who volunteered to join the study signed the informed consent form, which showed good compliance and cooperated with the follow-up; 2. Gastrointestinal pancreatic neuroendocrine carcinoma with liver metastases confirmed by histology or cytology; 3. 18-70 years old (boundary values included); 4. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2); 5. Life expectancy > 12 weeks; 6. Patients with neuroendocrine cancer who had disease progression following etoposide combined with carboplatin/cisplatin as first-line chemotherapy or disease progression within 6 months after termination of first-line therapy (according to RECIST 1.1 criteria); 7. Patients with unresectable type III liver metastases and Child-Pugh liver function = 1cm is accurately measured by enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT), and the study target lesion has not received local treatment (including but not limited to HAIC, radiofrequency ablation, argon-helium knife, radiation therapy) and other local treatments); 9. The main organs and bone marrow functions are basically normal (the use of any blood components and cell growth factors within 14 days before enrollment is not allowed): (1) Blood routine: white blood cells >= 4.0 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90g/L; (2) International Normalized Ratio (INR) = 50% detected by two-dimensional echocardiography; 10. Suitable for HAIC surgery pre-specified by the study center without any contraindications, can accept HAIC treatment; 11. Women of childbearing age must have taken a serum pregnancy test negative within 7 days prior to treatment and be willing to use medically approved effective contraception (e.g. an intrauterine device, contraceptive, or condom) during the study period and for 3 months after the last study drug use; For male subjects whose partner is a woman of reproductive age, surgical sterilization is required or effective contraceptive methods are recommended during the study period and for 3 months after the last study treatment; 12. All patients must provide tumor samples for central pathology review to verify that the patient's diagnosis and grading meet the inclusion criteria.
Exclusion criteria
Exclusion criteria: 1. Received approved or ongoing-study systemic anti-tumor therapy within 4 weeks before enrollment, including: photodynamic therapy, chemotherapy, radical radiotherapy, ablation, local radiotherapy (completed at least 2 weeks before study drug treatment palliative radiotherapy for metastases), biological immunotherapy, targeted therapy, etc.; 2. Previously received hepatic arterial chemoembolization or hepatic arterial infusion chemotherapy containing fluorouracil; 3. Participated in clinical trials of other domestically unapproved or unmarketed drugs within 4 weeks before enrollment and received corresponding experimental drug treatment; 4. Previously received or plan liver transplantation; 5. Had other malignancies within the past 5 years or at the same time (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 6. With untreated CNS metastases; 7. The patient currently has any disease or condition that affects drug absorption, or the patient cannot take surufatinib orally; 8. Patients with severe hypersensitivity to oxaliplatin, calcium folinate, fluorouracil and iodinated contrast agents; 9. Have taken drugs containing Hypericum perforatum components within 3 weeks before the study drug first-taken, or have taken other strong inducers or strong inhibitors of CYP3A4 within the first 2 weeks; 10. Received systemic, radical brain or meningeal metastases in the past (radiotherapy or surgery) (if imaging confirmed that the stability has been maintained for at least 1 month, asymptomatic patients can be included); 11. Received any surgery (except biopsy) or invasive treatment or operation within 4 weeks before enrollment and the surgical incision was not completely healed (except for venous catheterization, puncture, and drainage, etc.); 12. Investigator-determined clinically significant electrolyte abnormalities; 13. Uncontrollable hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite optimal drug treatment); 14. Urine routine indicates urinary protein >= ++, and the 24-hour urine protein quantification is greater than 1.0 g; 15. International Normalized Ratio (INR)>1.5 x Upper Limit of Normal (ULN), and Activated Partial Thromboplastin Time (APTT)>1.5 x ULN; 16. Gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator; 17. Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment(>30 ml within 3 months, appeared hematemesis, black dung, hematochezia) or hemoptysis (>5 mL of fresh blood within 4 weeks), etc. Or a history of thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months; 18. Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass surgery within 6 months before enrollment; congestive heart failure New York Heart Association (NYHA) class>2; Ventricular arrhythmia requiring medical therapy; electrocardiogram (ECG) showing QT c interval >= 480 ms; 19. Active or uncontrolled serious infection (>=CTCAE grade 2); 20. Unresolved toxicity > CTCAE grade 1 due to any prior anticancer therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Disease control rate (DCR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactYu Wang
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed