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A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.

NCT06371274 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-08-12

No results posted yet for this study

Summary

To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy.

Conditions

  • Triple-negative Breast Cancer

Interventions

DRUG

ATRA

ATRA is the main active metabolite of vitamin A. Studies have shown that ATRA can also reduce the number of MDSC in solid tumor patients, promote their differentiation and maturation, remove the immunosuppressive ability of MDSC, improve the tumor immune microenvironment, and thus improve the tumor treatment efficacy.

DRUG

Toripalimab

Toripalimab is a fully human monoclonal antibody injection against PD-1 receptor. The NMPA has accepted the application of Toripalimab for a new indication for the treatment of initial metastatic or relapsed metastatic TNBC with PD-L1 positive (CPS≥1).

Sponsors & Collaborators

  • Shanghai Longfine Biotechnology Co., Ltd.

    collaborator UNKNOWN

  • TopAlliance

    collaborator UNKNOWN

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Xiaochen Zhang, MD · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371274 on ClinicalTrials.gov