Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine T… (NCT07357623) | Clinical Trial Compass
RecruitingPhase 2
Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine Tumors
China96 participantsStarted 2025-09-22
Plain-language summary
The goal of this clinical trial is to investigate if chemotherapy works with surufatinib to treat pulmonary neuroendocrine tumors. It will also learn about the safety of this combination regimen. The main questions it aims to answer are:
Does chemotherapy combined with surufatinib could bring more survival benefits (ie. higher response rate or longer survival time) for patients with pulmonary neuroendocrine tumors? Is this combination regimen safe?
Researchers will compare chemotherapy plus surufatinib with surufatinib monotherapy to see if this combination regimen works to treat pulmonary neuroendocrine tumors.
Participants will:
Take chemotherapy(Etoposide+Carboplatin, EC or Capecitabine+Temozolomide, CAPTEM) plus surufatinib or surufatinib monotherapy every 3 or 4 weeks as a cycle.
Visit the clinic once every cycle for checkups and tests. Tumor assessment is performed every 2 cycles. Treatment will continued until disease progression, death, intolerable toxicity, or withdrawn.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have a full understanding of this study and voluntarily sign the informed consent form;
. 18-75 years old (including cut-off value), male or female;
. Patients must have at least one measurable lesion (RECIST 1.1);
. Histologically or cytologically confirmed pulmonary neuroendocrine tumor (typical or atypical carcinoid) \[at least one neuroendocrine immunohistochemistry marker (CD56, CgA, Syn) definitively positive on the basis of morphological features of neuroendocrine tumors\];
. Patients who have not received systemic therapy in the past (Note: neoadjuvant or adjuvant chemotherapy is allowed in the early stage, and if disease progression/recurrence occurs ≥ 6 months after the end of neoadjuvant/adjuvant last therapy, it can also be included);
. ECOG PS 0-1 (PS 0-2 for amputees);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR)(RECIST1.1)
Timeframe: From date of enrollment to the end of treatment, an average of 1.5 years
. Blood test (without blood transfusion within 14 days) 1) Absolute neutrophil value ≥1.5×109/L, platelet ≥ 100×109/L, hemoglobin ≥9g/dL; 2) Liver function tests (AST and ALT≤2.5×ULN, total bilirubin≤1.5×ULN; AST and ALT ≤5×ULN) if liver metastases are present; 3) Renal function (serum creatinine ≤1.5×ULN, creatinine clearance (CCr) ≥60ml/min);
Exclusion criteria
. Patients who have received surufatinib or other anti-angiogenic drugs in the past;
. Received approved or investigational systemic anti-tumor therapy within 4 weeks before enrollment, including: chemotherapy, any form of radiotherapy, biological immunotherapy, targeted therapy, etc.;
. Participated in other domestic drug clinical trials that have not been approved or marketed within 4 weeks before enrollment and received corresponding trial drug treatment;
. Undergoing any surgery or invasive treatment or operation within 4 weeks before enrollment that affects wound healing (except for intravenous catheterization, puncture and drainage, etc.);
. International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \>1.5× ULN;
. Clinically significant electrolyte abnormalities judged by the investigator;
. Presence of hypertension that cannot be controlled by medication, as prescribed as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
. Patient currently has any disease or condition that affects drug absorption, or patient cannot take surufatinib orally;