RecruitingPhase 2NCT06165900

Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC

A Multicenter, Randomized Trial of Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) Versus Adebrelimab Combined With TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of Triple-negative Breast Cancer


Sponsor

Shengjing Hospital

Enrollment

136 participants

Start Date

Sep 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests stereotactic radiotherapy (highly precise, high-dose radiation) combined with adebrelimab (an immune checkpoint inhibitor) and chemotherapy (carboplatin and paclitaxel) for people with locally advanced non-small cell lung cancer (NSCLC). The goal is to shrink the tumor and improve outcomes. **You may be eligible if...** - You are 18 or older with locally advanced non-small cell lung cancer (Stage III) - Your disease has not spread to distant organs - Your general health and lung function allow chemotherapy and radiation - You have not had prior systemic cancer treatment for this cancer **You may NOT be eligible if...** - Your cancer has spread beyond the chest (Stage IV) - You have active autoimmune disease - You have severe lung disease (COPD, pulmonary fibrosis) that makes treatment risky - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGadebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

Adebrelimab plus radiotherapy phase: radiotherapy was started on the day of the second cycle of adebrelimab administration every other day for 3 fractions; Adebrelimab plus chemotherapy phase: starting within 3-5 weeks after completion of radiotherapy, every 3 weeks for 6 cycles.

DRUGadebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)


Locations(1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

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NCT06165900


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