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).
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;
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;
Single group
Sintilimab+Temozolomide+Surufatinib
DrugAfter 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.
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.
Progression-free survival
Time from randomization/treatment initiation to disease progression (PD), or death from any cause (whichever occurs first).
Disease control rates
The proportion of patients who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Overall survival
The time from randomization/treatment initiation to death from any cause.
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.
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