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RECRUITING
NCT06817525
PHASE2

Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

Summary

We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.

Official title: Nab-P+Cb+PD1 Inhibitor Neoadjuvant Therapy for Early TNBC: a Single Center, Non Blinded, Randomized Phase II Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2024-11-06

Completion Date

2026-05-31

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

DRUG

6*Nab-P (d 1)+6*Cb ( d 1)+6*PD1 (d 1)

This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage. Group A: Albumin-bound paclitaxe (260 mg/m²,d 1)+Carboplatin (AUC=5, d 1)+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles;

DRUG

6*Nab-P (d 1,8,15)+6*Cb ( d 1)+6*PD1 (d 1)

This study is a single center, non blinded, randomized phase II clinical trial. A total of 64 TNBC patients are planned to be enrolled. Patients who meet the inclusion criteria will be randomly divided into two groups at a ratio of 1:1 and stratified according to T stage and N stage. Group B: Albumin-bound paclitaxe (125 mg/m²,d 1,8,15)+Carboplatin (AUC=5, d 1 )+Camrelizumab (200 mg, d 1), 21 days as one cycle, 6 cycles;

Locations (1)

Henan cancer hospital

Zhengzhou, Henan, China