Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • surufatinib

    Drug

    Surufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 years

Secondary outcomes

1

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.

Time frame
4 years
2

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.

Time frame
4 years

Other outcomes

1

Biomarkers

Concentrations of NSE and ProGRP in blood samples, evaluated as percentage changes at each tumor assessment from baseline to treatment

Time frame
4 years

Locations

This trial has no locations.

Sponsors and contacts

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