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Neuroendocrine Carcinomas (NEC)Phase 2NCT07156019

Sintilimab in Combination With Surufatinib and Temozolomide in the Advanced Neuroendocrine Carcinoma

A Phase 2 study testing Sintilimab+Temozolomide+Surufatinib in people with Neuroendocrine Carcinomas (NEC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study will evaluate the efficacy, safety and tolerability of Surufatinib + Temozolomide + Sintilimab in subjects. A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neuroendocrine Carcinomas (NEC)
What is being tested?
Sintilimab+Temozolomide+Surufatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
Oct 2025to Dec 2027
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
  • Locally advanced unresectable or metastatic neuroendocrine carcinoma confirmed by histopathology or cytology (excluding small cell lung cancer);
  • Disease progression or toxicity intolerance after previous first-line and above treatment;
  • At least one measurable lesion according to RECIST v1.1;
  • Eastern Cooperative Oncology Group Performance Status（ECOG PS） score is 0-1;
  • Age ≥18 and ≤75 years old;
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  • Can provide tumor specimens for biomarker detection；
  • Major organ and bone marrow function levels meet the following requirements within 7 days prior to treatment:
  • ① Blood routine: Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥90×10^9/L; Hemoglobin (Hb) ≥9.0 g/dL; Have not received transfusions of blood products (including erythrocyte and platelet products, etc.) and have not used supportive therapy of growth factors (including colony-stimulating factor, interleukin and erythropoietin, etc.) within 2 weeks before the examination;
  • ② Liver function: serum total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN); alanine Aminotransferase（ALT） and aspartate aminotransferase (AST) in subjects without liver metastasis ≤3.0×ULN, and ALT and AST in subjects with liver metastasis ≤5.0×ULN;
  • ③ Renal function: serum creatinine (Cr) ≤1.5×ULN;
  • ④ Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
  • ⑤ Urine routine results showed that urine protein <2+; For patients with urine protein ≥2+ in routine urine testing at baseline, a 24-hour urine protein quantity of <1g is required;
  • Expected survival time ≥3 months;
  • Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period.

Who cannot join

  • Previous exposure to any anti-PD-1 /PD-L1/PD-L2/CTLA-4 antibody, VEGF/VEGFR targeting drugs;
  • Previous treatment with temozolomide;
  • Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs within 4 weeks prior to enrollment, or remained within 5 half-lives of such drugs;
  • Known to be allergic to any monoclonal antibody, temozolomide preparations, and solfantinib preparations;
  • Use of immunosuppressive drugs within 4 weeks prior to initial administration, excluding nasal, inhalation, or other routes of local corticosteroids or physiological doses of systemic corticosteroids;
  • There was toxicity caused by previous anti-tumor therapy that did not recover to NCI CTCAE5.0 version ≤ Grade 1 before the first administration;
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  • History of other primary malignancies, except the following: non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence, carcinoma in situ with adequate treatment and no evidence of disease recurrence;
  • Patients with metastatic central nervous system or cancerous meningitis with clinical symptoms;
  • Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;
  • Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
  • Have serious heart disease or discomfort;
  • The patient has any active autoimmune disease or a history of autoimmune disease within 2 years;
  • Pregnant or nursing female patients;
  • A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Had undergone major surgery within 4 weeks prior to enrollment or expected to require major surgery during the study treatment;
  • Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
  • Has a serious concomitant disease or other comorbidities that interfere with planned treatment;
  • Any other circumstances deemed inappropriate for participation in this study by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yihebali Chi contact

010-67781331

yihebalichi@hotmail.com

About this study

Official title: A Prospective, Single-center, Single-arm Phase II Study of Sintilimab in Combination With Surufatinib and Temozolomide in the Treatment of Advanced Neuroendocrine Carcinoma

This study will evaluate the efficacy, safety and tolerability of Surufatinib + Temozolomide + Sintilimab in subjects. A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months. Efficacy evaluation was performed at the end of every 2 treatment cycles. After termination of study treatment, participants will be followed up for safety and survival (survival follow-up every 90 days).

Read the detailed description

This study will evaluate the efficacy, safety and tolerability of Surufatinib + Temozolomide + Sintilimab in subjects. After fully informed and signed informed consent, subjects will receive Sintilimab (200mg each fixed dose, once every 21 days) combined with Temozolomide (body surface area（BSA）≤1.7m2; BSA >1.7m2 was administered with 300mg, once daily, d1-d5, and with Surufatinib (250mg, once daily, continuous administration). A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months. Efficacy evaluation was performed at the end of every 2 treatment cycles. For subjects whose disease progression was evaluated for the first time according to Response Evaluation Criteria in Solid Tumors, version 1.1（RECIST v1.1）, the investigator determined that the subjects were clinically stable and still had clinical benefit, the subjects could continue to receive treatment, and the disease progression was confirmed according to Immune Response Evaluation Criteria in Solid Tumors（iRECIST） criteria 4-6 weeks later. After termination of study treatment, participants will be followed up for safety and survival (survival follow-up every 90 days).

Being tested
Sintilimab+Temozolomide+Surufatinib
Keywords
Surufatinib, Temozolomide, Sintilimab, Neuroendocrine carcinomas, Prospective observational study
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

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

  • Sintilimab+Temozolomide+SurufatinibDrug

    After fully informed and signed informed consent, subjects will receive Sintilimab (200mg each fixed dose, once every 21 days) combined with Temozolomide (BSA≤1.7m2; BSA \&amp;amp;gt; 1.7m2 was administered with 300mg, QD, d1-d5, and with Surufatinib (250mg, QD, continuous administration). A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months.

Study groups in NCT07156019
Study groupRoleWhat they receive
Surufatinib + Surufatinib + SintilimabExperimentalAfter fully informed and signed informed consent, subjects will receive Sintilimab (200mg each fixed dose, once every 21 days) combined with Temozolomide (body surface area（BSA）≤1.7m2; BSA >1.7m2 was administered with 300mg, once daily, d1-d5, and with Surufatinib (250mg, once daily, continuous administration). A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months.
Receives: Drug: Sintilimab+Temozolomide+Surufatinib

What is being measured

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

  1. Objective response rate

    Objective response rates assessed according to RECIST v1.1 criteria. It defines as the proportion of patients who achieve either a Complete Response (CR) or Partial Response (PR) of total evaluable patients.

    Measured: From enrollment to the end of treatment at 1 year

Secondary outcomes (4)

  1. Progression-free survival

    Time from randomization/treatment initiation to disease progression (PD), or death from any cause (whichever occurs first).

    Measured: From enrollment to the end of treatment at 1 year

  2. Disease control rates

    The proportion of patients who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD).

    Measured: From enrollment to the end of treatment at 1 year

  3. Overall survival

    The time from randomization/treatment initiation to death from any cause.

    Measured: From enrollment to the end of treatment at 1 year

  4. Incidence of Treatment-Emergent Adverse Events

    Incidence and severity of adverse events (AES) and serious adverse events (SAEs) during treatment as assessed by the National Cancer Institute Standard for Common Terminology for Adverse Events (CTCAE) version 5.0 and their association with the investigational drugs.

    Measured: From enrollment to the end of treatment at 1 year

Timeline

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

  1. First posted4 Sep 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07156019
Sponsor's protocol ID
24/371-4651
Status last verified
Sep 2025
First submitted
21 Dec 2024
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab+Temozolomide+Surufatinib in people with Neuroendocrine Carcinomas (NEC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

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 15 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: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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 Yihebali Chi (010-67781331, yihebalichi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From enrollment to the end of treatment at 1 year). 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 NCT07156019.

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 4 Sep 2025.

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