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Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine Tumors

ConditionPulmonary Neuroendocrine Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Chest Hospital

About this trial

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 Treatment will continued until disease progression, death, intolerable toxicity, or withdrawn.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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];

Disqualifiers

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.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surufatinib Combined With Standard chemotherapy

    Drug

    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

    Drug

    Surufatinib: 300mg, qd, po

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Surufatinib Combined With Standard chemotherapyExperimental treatment 1 intervention
Group B: SurufatinibActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective 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

Secondary outcomes

1

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
2

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
3

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Source ClinicalTrials.gov
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