Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

Eligibility criteria

Qualifiers

Histopathologically confirmed locally advanced or metastatic unresectable ESCC, BTC, PC or GC with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CgA, Syn));

Have at least one measurable lesion according to RECIST v1.1;

ECOG performance status: 0-1;

No previous systemic therapy;

Disqualifiers

Have uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;

With active bleeding or bleeding tendency;

Severe history of cardiovascular and cerebrovascular diseases;

Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

Trial design

Treatments tested in this trial

  • Surufatinib
  • Serplulimab
  • standard chemotherapy

Treatment groups

80 Participants
are divided into 1 treatment group

Locations

1
Renji hospital200127, ShanghaiShanghai Municipality, China

Sponsors and collaborators

RenJi Hospital

Lead sponsor