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

Shanghai Jiao Tong University

Status and phase

Not yet enrolling

Phase 2

Conditions

Gastric Cancer

Biliary Tract Cancer

ESCC

Pancreas Cancer

Treatments

Drug: Surufatinib

Drug: Serplulimab

Drug: standard chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06531291

CPOGCNED-14

Details and patient eligibility

About

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.

Full description

This is a single-arm, multi-cohort, open-label, single-center, prospective, exploratory clinical study. We planned to enroll 80 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment of advanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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;
Urine protein< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
Expected survival time > 3 months;

Exclusion criteria

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.