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

NCT ID: NCT06531291

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-10

Study Completion Date

2027-08-09

Brief Summary

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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

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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.

Conditions

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ESCC Biliary Tract Cancer Gastric Cancer Pancreas Cancer

Keywords

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surufatinib Neuroendocrine Differentiation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surufatinib + serplulimab + standard chemotherapy

Group Type EXPERIMENTAL

Surufatinib

Intervention Type DRUG

250 mg, po, qd, q3w

Serplulimab

Intervention Type DRUG

200 mg, iv, d1, q3w

standard chemotherapy

Intervention Type DRUG

Decided by PI

Interventions

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Surufatinib

250 mg, po, qd, q3w

Intervention Type DRUG

Serplulimab

200 mg, iv, d1, q3w

Intervention Type DRUG

standard chemotherapy

Decided by PI

Intervention Type DRUG

Eligibility Criteria

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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;

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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liwei wang

Director of department of oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liwei Wang, Doctorate

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Renji hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Liwei Wang, Doctorate

Role: CONTACT

Phone: +86 16621086648

Email: [email protected]

Liwei Wang

Role: CONTACT

Phone: +86 16621086648

Email: [email protected]

Facility Contacts

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Liwei Wang, Dr

Role: primary

Other Identifiers

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CPOGCNED-14

Identifier Type: -

Identifier Source: org_study_id