Status:
NOT_YET_RECRUITING
Sintilimab in Combination With Surufatinib and Temozolomide in the Advanced Neuroendocrine Carcinoma
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Neuroendocrine Carcinomas (NEC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 intoleran...
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 Sintilima...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07156019
Start Date
October 1 2025
End Date
December 1 2027
Last Update
September 4 2025
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