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NCT06401005Not yet recruiting

SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)

A Single-arm, Open, Phase II Clinical Study of SBRT, Chemotherapy, and Ivonescimab Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)
Hubei Cancer HospitalPhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Breast Cancer
Drug/Device/Intervention
Lvonescimab (AK112)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Hubei Cancer Hospital
Timeline & enrollment
Phase
Phase 2
Start date
Sep 01, 2024
End date
Sep 01, 2027
Enrollment
51 participants
Primary outcome

Complete pathologic remission (pCR) rate

Summary

Studies have indicated that the improvement in pathological complete response (pCR) is
 significantly correlated with triple-negative breast cancer(TNBC)patients' overall survival
 (OS). Patients with TNBC have poor efficacy for neoadjuvant chemotherapy. The combination of
 neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the
 pCR rate of TNBC patients, increasing it from 45% to approximately 60%. Therefore, how to
 further improve the pCR rate of luminal-type breast cancer became the main objective of this
 study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills
 the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+
 T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered
 that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and
 efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1/VEGF-A bispecific
 antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was
 proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant
 treatment modality, in the treatment of TNBC.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06401005
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06401005 through Pure Global AI's free database. This Phase 2 trial is sponsored by Hubei Cancer Hospital and is currently Not yet recruiting. The study focuses on Breast Cancer. Target enrollment is 51 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.