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 Treatment will continued until disease progression, death, intolerable toxicity, or withdrawn.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Surufatinib: 250mg , qd, po, Q4W Capecitabine: 75mg/m2, bid, po, D1-D14, Q4w Temozolomide: 150mg-200mg/m2, qd, po, D10-D14, Q4W or Surufatinib: 250mg , qd, po, Q3W Etoposide: 100mg/m2, IV, D1-D3, Q3W Carboplatin: AUC=5, IV, D1, Q3W
Surufatinib: 300mg, qd, po
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGShanghai chest hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate (ORR)(RECIST1.1)
The incidence of confirmed complete response or partial response
Time frame: From date of enrollment to the end of treatment, an average of 1.5 years
Disease control rate (DCR)(RECIST1.1)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Time frame: From date of enrollment to the end of treatment, an average of 1.5 years
Progression-free Survival (PFS) (RECIST1.1)
A duration from the date of randomization to disease progression or death of any cause.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival (OS)
Duration from the date of randomization to the date of death due to any cause
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
4-month PFS rate
Proportion of patients who did not develop disease progression (or death from any cause) at 4 months from the date of randomization
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 months
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