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Neuroendocrine CarcinomaPhase 1/2NCT05747729

A Single-arm, Open-label, Clinical Trial of Surufatinib/Serplulimab/Platinum/Etoposide in Neuroendocrine Carcinoma.

A Phase 1/2 study testing Surufatinib and Serplulimab in people with Neuroendocrine Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a prospective open-label, single-arm, single-center clinical study. Patients with neuroendocrine carcinoma who had not previously received standard therapy were enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Carcinoma
What is being tested?
Surufatinib and Serplulimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
21 Jun 2023to 28 Jul 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent;
  • With histologically or cytologically confirmed extra-pulmonary neuroendocrine carcinoma (including mixed neuroendocrine or non-neuroendocrine tumors [at least 30% neuroendocrine carcinoma component]);
  • Previously untreated with systemic therapy;
  • age ≥18 years;
  • Have at least one measurable lesion according to RECIST v1.1;
  • ECOG performance status: 0-1;
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  • Expected survival time > 3 months;
  • For evidence of sufficient organ functions, the subjects shall meet the following laboratory parameters: 1) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without use of granulocyte colony stimulating factor in recent 14 days; 2) Platelet count ≥ 100 × 109/L without blood transfusion in recent 14 days; 3) Hemoglobin > 9 g/dL without blood transfusion or erythropoietin use in recent 14 days; 4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); or total bilirubin > ULN, direct bilirubin ≤ ULN; 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (ALT or AST ≤ 5 × ULN for patients with liver metastasis); 6) Blood creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft- Gault formula) ≥ 50 mL/min;
  • Women of childbearing potential need to use at least one medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment and within 180 days after the end of the study treatment; Before the first dose, serum HCG examination must be negative; and women must be non-lactating.

Who cannot join

  • Neuroendocrine carcinoma of the lung;
  • With known allergic reactions to the drugs in this study;
  • Unable or unwilling to swallow Surufatinib or suffering from significant digestive system diseases that may interfere with absorption, metabolism, or excretion;
  • With clinically significant or uncontrolled heart diseases, including unstable angina, acute myocardial infarction within 6 months before the first dose, grade III/IV congestive heart failure (New York Heart Association), and uncontrolled arrhythmia (subjects with pacemakers or with atrial fibrillation but well controlled heart rate are allowed); With ECG changes or medical history considered clinically significant by the investigator; QTc interval > 450 ms for male or > 470 ms for female at screening;
  • With active ulcers, intestinal perforation, and intestinal obstruction;
  • With active bleeding or bleeding tendency;
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  • With uncontrolled hypertension (systolic pressure > 150 mmHg or diastolic pressure > 100 mmHg) after the optimal medical treatment;
  • Urine protein ≥ ++ and the amount of urine protein in 24 hours >1.0g;
  • Any active autoimmune disease requiring systemic treatment or with a history of autoimmune disease within 2 years, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, hypophysitis, vasculitis, systemic lupus erythematosus, etc. (Vitiligo, psoriasis, alopecia or Grave's disease without systemic treatment within the past 2 years, and type I diabetic patients who only need insulin replacement therapy can be included); with a history of primary immunodeficiency; patients only with positive autoimmune antibody need to confirm according to the investigator;
  • Received systemic immunostimulant therapy within 4 weeks before the first dose;
  • Received any live vaccines or live attenuated vaccines within 4 weeks prior to the first dose or planned to be administered live vaccines or live attenuated vaccines during the study;
  • Pleural effusion, ascites, or pericardial effusion with obvious clinical symptoms that require drainage;
  • Diagnosed with malignant tumors within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ;
  • Presence of severe infection in the active phase or with poor clinical control;
  • With known history of human immunodeficiency virus (HIV) infection or confirmed with positive immune test results;
  • Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA > 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA > 103 copies/mL; or other hepatitis, liver cirrhosis.
  • Symptomatic brain metastases (confirmed or suspected)
  • The investigator confirms that the patients has any clinical or laboratory abnormalities who are not suitable for participating in this clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tao Zhang contact

8618971656660

1277577866@qq.com

China1 site, 1 recruiting

  • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Tao Zhang, MD, 027-85871982, 1277577866@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open-label, Single-center Clinical Trial of Surufatinib and Serplulimab Combined With Standard Chemotherapy (Platinum/Etoposide) in Neuroendocrine Carcinoma.

This study is a prospective open-label, single-arm, single-center clinical study. Patients with neuroendocrine carcinoma who had not previously received standard therapy were enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. This clinical trial evaluates the efficacy and safety of surufatinib and serplulimab combined with standard chemotherapy (Platinum/Etoposide) in neuroendocrine carcinoma.

Being tested
Surufatinib and Serplulimab
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surufatinib and SerplulimabDrug

    Surufatinib: Safety lead-in : Oral, QD, starting dose 250 mg, adjusted according to DLT. Dose expansion: administration according to the dose determined in the safety lead-in phase.

    Serplulimab: 300 mg intravenous infusion on day 1, repeated every 3 weeks.

Study groups in NCT05747729
Study groupRoleWhat they receive
Surufatinib/Serplulimab/Platinum/EtoposideExperimentalNot described
Receives: Drug: Surufatinib and Serplulimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival

    Progression-Free Survival (PFS) According to RECIST v1.1 criteria

    Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start21 Jun 2023
  3. Primary completion28 Oct 2026 (estimated)
  4. Study completion28 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05747729
Sponsor's protocol ID
UNIONEC
Status last verified
Jul 2026
First submitted
18 Feb 2023
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Surufatinib and Serplulimab in people with Neuroendocrine Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tao Zhang (8618971656660, 1277577866@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05747729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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