Surufatinib Combined With Serplulimab And Standard Chemotherapy As First-line Treatment In Advanced Solid Tumors With Neuroendocrine Differentiation

Study Overview

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

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.

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.

ESCC
Biliary Tract Cancer
Gastric Cancer
Pancreas Cancer

DRUG: Surufatinib
DRUG: Serplulimab
DRUG: standard chemotherapy

CPOGCNED-14

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-07-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-28
First Submitted that Met QC Criteria 2024-07-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-31
First Posted (ACTUAL) 2024-07-31	Results First Posted N/A	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Surufatinib + serplulimab + standard chemotherapy	DRUG: Surufatinib 250 mg, po, qd, q3w DRUG: Serplulimab 200 mg, iv, d1, q3w DRUG: standard chemotherapy Decided by PI

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Surufatinib + serplulimab + standard chemotherapy

DRUG: Surufatinib

250 mg, po, qd, q3w

DRUG: Serplulimab

200 mg, iv, d1, q3w

DRUG: standard chemotherapy

Decided by PI

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

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Liwei Wang, Doctorate

Phone Number: +86 16621086648

Email: lwwang2013@163.com

Study Contact Backup

Name: Liwei Wang

Phone Number: +86 16621086648

Email: lwwang2013@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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;

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Liwei Wang, Doctorate, RenJi Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record