Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carbop... | NCT07283692

Studies
Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)

NCT07283692

Sponsor

RenJi Hospital

Status

Recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

46Estimated

Phase

Phase 2

Conditions

Triple Negative Breast Cancer

Interventions

Serplulimab
Paclitaxel
Carboplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Sep 2031Estimated

First Submitted Date

Dec 4, 2025

First Submission Date that Met QC Criteria

Dec 4, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant serplulimab plus weekly paclitaxel and carboplatin in patients with triple-negative breast cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neoadjuvant serplulimab	Experimental	serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy	Drug: Serplulimab Drug: Paclitaxel Drug: Carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serplulimab	Drug	1.5mg/kg qw, start from C1D15	neoadjuvant serplulimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with pCR	Number of patients with pathological complete response/Number of all eligible patients	1-2 weeks after surgery

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with adverse events	Number of patients with adverse events during neoadjuvant therapy assessed according to the NCI CTCAE v5.0/Number of all eligible patients	From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, Aged ≥18 and ≤70 years
Histologically confirmed triple negative breast cancer (ER<10%, PR<10%, and HER2 negative)
Subjects with at least one evaluable lesion
ECOG 0-1
Adequate organ function

Exclusion Criteria:

Metastatic disease (Stage IV)
Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenjin Yin, M.D.	Contact	86(21)68385569		yinwenjin@renji.com

Overall Officials

Name	Affiliation	Role
Wenjin Yin, M.D.	Renji Hospital,School of Medicine, Shanghai Jiaotong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, School of Medicine, Shanghai Jiaotong University	Recruiting	Shanghai		200127	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study protocol, SAP and ICF are to be shared with other researchers.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

starting 6 months after publication

Access Criteria

IPD can be accessed from the corresponding author on reasonable request.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D064726	Triple Negative Breast Neoplasms
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017239	Paclitaxel
D016190	Carboplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided