About this trial
The following issues warrant in-depth investigation: further refinement of staging by primary tumor site, the increasing prognostic weight of T classification, risk assessment for lymph node metastasis and postoperative recurrence/distant metastasis, and whether NET G3 with poor prognosis requires more aggressive postoperative intervention. This study plans to enroll patients classified as Stage III according to the AJCC 9th Edition staging system, including NET G1/G2 and all G3 patients, for a clinical trial on postoperative adjuvant therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide written informed consent and voluntarily participate in the study.
Aged 18-80 years, male or female.
Confirmed as Stage III NET G1/G2 or any-stage NET G3 after surgical treatment.
Other postoperative NET patients deemed by the investigator to have high-risk factors.
Disqualifiers
Major surgery, open biopsy, or significant trauma within 28 days prior to the first dose.
History of severe or poorly controlled interstitial lung disease.
Poorly controlled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite antihypertensive medication.
Significant bleeding tendency or clinically significant bleeding within 3 months prior to the first dose (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis).
Trial design
Single group
Treatments tested in this trial
surufatinib
DrugSurufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy.
Treatment groups
Trial outcomes
Primary outcomes
Recurrence Free Survival(RFS)
Refers to the time from when a patient achieves complete response after anticancer therapy or surgery until the occurrence of disease recurrence or death from any cause.
Secondary outcomes
Overall Survival (OS)
Refers to the time from the start of randomization (or the start of treatment in a single-arm trial) until death due to any cause.
Adverse Event (AE)
In a drug clinical trial, it refers to all adverse medical events that occur in subjects after receiving the investigational medicinal product, which can manifest as symptoms, signs, diseases, or laboratory abnormalities, but are not necessarily causally related to the investigational medicinal product.
Other outcomes
Biomarkers
Concentrations of NSE and ProGRP in blood samples, evaluated as percentage changes at each tumor assessment from baseline to treatment
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: