drugset / Trial / NCT04722718

Efficacy and Safety of Sintilimab and Apatinib Combined Chemotherapy in Breast Cancer

NCT04722718 ↗

Phase 2 Unknown 34 enrolled Jiuda Zhao
NaSingle-groupOpen-labelTreatment

Summary

1. The efficacy and safety of immunotherapy and antiangiotherapy in combination with chemotherapy in neoadjuvant therapy for triple-negative breast cancer (TNBC) were determined by the addition of sintilimab and apatinib to neoadjuvant chemotherapy 2. To clarify the breast-conserving rate, toxicity, difference in pathologic complete response (pCR) rate of patients with PD-L1 (+) and PD-L1 (-) after neoadjuvant treatment of TNBC with immunotherapy and anti-vascular therapy combined with chemotherapy and the relationship between pCR rate of immunomodulated type (IM) and non-immunomodulated type patients in "Fudan classification". 3. Through post-treatment efficacy evaluation and safety analysis, we provide new treatment strategies for TNBC patients, increase the pCR rate of TNBC patients, and ultimately improve the long-term survival of patients.

Timeline

Start
2021-02-01
Primary completion
2022-12-31
Completion
2023-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Rivoceranib Small molecule 250 mg Oral
Subject Sintilimab Monoclonal antibody 200 mg Intravenous

Indications