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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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).

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Sintilimab+Temozolomide+Surufatinib

Treatment groups

32 Participants
are divided into 1 treatment group

Locations

This trial has no locations