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

NCT07156019 | Not Yet Recruiting Phase 2

• 1 other identifier: 24/371-4651
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Neuroendocrine Carcinomas (NEC)

Keywords

Surufatinib; Temozolomide; Sintilimab; Neuroendocrine carcinomas; Prospective observational study

Outcome Measures

Primary Outcomes (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.

  From enrollment to the end of treatment at 1 year

Secondary Outcomes (4)

• Progression-free survival

  From enrollment to the end of treatment at 1 year

• Disease control rates

  From enrollment to the end of treatment at 1 year

• Overall survival

  From enrollment to the end of treatment at 1 year

• Incidence of Treatment-Emergent Adverse Events

  From enrollment to the end of treatment at 1 year

Study Arms (1)

Surufatinib + Surufatinib + Sintilimab

EXPERIMENTAL

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.

Drug: Sintilimab+Temozolomide+Surufatinib

Interventions

Sintilimab+Temozolomide+Surufatinib DRUG

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 \> 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.

Surufatinib + Surufatinib + Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Yihebali Chi

  National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Yihebali Chi

CONTACT

010-67781331; yihebalichi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: September 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share