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

Phase 2

Not yet recruiting

• Conditions: ESCC; Biliary Tract Cancer; Gastric Cancer; Pancreas Cancer
• Interventions: Drug: Surufatinib; Drug: Serplulimab; Drug: standard chemotherapy

• Registration Number: NCT06531291
• Lead Sponsor: RenJi Hospital

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 chemo...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-28
• Last Update Submitted: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Study Start: 2024-08-10
• Primary Completion: 2027-08-09
• Study Completion: 2027-08-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 &gt; 3 months;

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Exclusion Criteria

• Have uncontrolled hypertension, defined as systolic blood pressure &gt;150 mmHg or diastolic blood pressure &gt;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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surufatinib + serplulimab + standard chemotherapy	Surufatinib	-
Surufatinib + serplulimab + standard chemotherapy	Serplulimab	-
Surufatinib + serplulimab + standard chemotherapy	standard chemotherapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Renji hospital; 🇨🇳 Shanghai, Shanghai, China