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

Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06531291

Enrollment

Registered

2024-07-31

Start date

2024-08-10

Completion date

2027-08-09

Last updated

2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer, ESCC, Gastric Cancer, Pancreas Cancer

Keywords

surufatinib, Neuroendocrine Differentiation

Brief summary

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.

Detailed 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.

Interventions

DRUGSurufatinib

250 mg, po, qd, q3w

DRUGSerplulimab

200 mg, iv, d1, q3w

DRUGstandard chemotherapy

Decided by PI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Progression-Free Survival (PFS)	approximately 1 years	time from first-dose to the first documented disease progression or death

Secondary

Measure	Time frame	Description
Objective response rate (ORR)	approximately 1 years	the proportion of patients with complete response or partial response, using RESIST v1.1
Disease Control Rate (DCR)	approximately 1 years	the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1

Countries

China

Contacts

Primary ContactLiwei Wang, Doctorate

lwwang2013@163.com+86 16621086648

Backup ContactLiwei Wang