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A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC

NCT06632405 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-26

No results posted yet for this study

Summary

This is a phase II, explorative, open-labeled, multi-centered, double-arm, investigator-initiated clinical trial of Camrelizumab (an anti-PD-1 antibody) in combination with Nab-paclitaxel (a chemotherapeutic agent against breast cancer) and Levocetirizine (an antihistamine) in patients with advanced triple-negative breast cancer. 60 subjects will be enrolled in multiple centers. This study aims to evaluate the effects of Camrelizumab combined with Nab-paclitaxel and Levocetirizine in the treatment of advanced TNBC.

Conditions

Interventions

DRUG

Camrelizumab

Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.

DRUG

Nab paclitaxel

Nab paclitaxel 100mg/m2 will be administered as an intravenous infusion every 4 weeks in d1,8,15until unacceptable toxic effects or disease progression or other termination criteria appeared.

DRUG

Levocetirizine Hydrochloride

5mg daily, start 3 days before the 1st administration

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Jieqiong Liu · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-03-31
Completion
2027-03-31

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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 NCT06632405 on ClinicalTrials.gov