Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University

About this trial

This is a phase II, single arm, open-label, multicenter study to evaluate the efficacy and safety of Sintilimab combined with IBI310 and Surufatinib for the treatment of high-grade advanced-neuroendocrine neoplasm

Eligibility criteria

Qualifiers

Fully aware of this study and voluntary to sign the informed consent form (the informed consent form must be signed before any trial-specific procedure is performed);

Aged 18-75 (inclusive);

Histologically or cytologically confirmed patients with inoperable or metastatic high-grade neuroendocrine neoplasm (Ki67 index > 20% or with mitotic count of more than 20 mitoses per high power field);

Patients who failed to receive standard treatment (Have progressed on previous treatment, or treatment toxicity and side effects are not tolerated), or cannot receive standard treatment (including patients who are intolerant to standard treatment, who are judged by the investigator to be unsuitable for standard treatment or who refuse to receive standard treatment), or who have no standard treatment plan;

Disqualifiers

Presence of other malignancies in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix, which were effectively controlled);

Currently participate in an interventional clinical study, or have been treated with another study drug or medical equipment within 4 weeks prior to the first dose;

Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways (including but not limited to OX-40, CD137, etc.), anti-VEGF/VEGFR-targeted drugs;

Having abnormal thyroid function with symptoms ongoing or requiring treatment at screening (only hypothyroidism that can be controlled by thyroid hormone replacement therapy can be included);

Trial design

Treatments tested in this trial

  • Sintilimab
  • IBI310
  • Surufatinib

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Peking University

Lead sponsor

Peking University Cancer Hospital & Institute

Sponsor institution