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

NCT04722718 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sintilimab+Apatinib+Albumin-Bound Paclitaxel(Nab-Paclitaxel)+Carboplatin

Sintilimab:200mg,ivgtt,d1,21days/cycle;Apatinib:250mg po,d1-14days,21days/cycle;Albumin-Bound Paclitaxel(Nab-Paclitaxel):125mg/m2,ivgtt,d1,d8,21days/cycle;Carboplatin:AUC=1.5,ivgtt,d1,d8, 21days/cycle.Monitoring of blood routine, biochemical and urine routine, electrocardiogram, and record the patient's drug-related adverse reactions every cycle,according to the curative effect of patients, compliance and tolerance, neoadjuvant therapy 6 cycles,every 2 cycles to evaluate curative effect (ultrasonic, breast X-ray CT, bone scan, brain, lungs, assessment and breast MRI imaging).

Sponsors & Collaborators

  • Jiuda Zhao

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04722718 on ClinicalTrials.gov