Trial Title:
A Phase II Trial of Camrelizumab in Combination With Apatinib for Neoadjuvant Treatment of Early-stage TNBC With a High Proportion of TILs
NCT ID:
NCT05556200
Condition:
Breast Cancer
Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Apatinib
Antibodies
Antibodies, Monoclonal
Tyrosine Kinase Inhibitors
Conditions: Keywords:
anti-PD-1 antibody
VEGFR2 TKI
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Anti-PD-1 monoclonal antibody
Description:
Camrelizumab 200 mg, iv, d1, q3W (3 mg/kg if weight <50 kg)
Arm group label:
Experiment
Other name:
Camrelizumab
Intervention type:
Drug
Intervention name:
VEGFR2 Tyrosine Kinase Inhibitor
Description:
Apatinib 250 mg, po, qd
Arm group label:
Experiment
Other name:
Apatinib
Summary:
This is a phase II, open-labeled, multi-centered, single-arm, investigator-initiated
clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a
VEGFR2 TKI) for neoadjuvant treatment of patients with triple-negative breast cancer and
>10% tumor-infiltrating lymphocytes (TILs) in baseline breast tumors. We will enroll 58
subjects (Simon's two stage design). The study is designed to evaluate the efficacy and
safety of camrelizumab in combination with apatinib in the neoadjuvant treatment of TNBC
with a high proportion of TILs.
Detailed description:
This a phase II, open-labeled, multi-centered, single-arm, investigator-initiated
clinical trial to assess the efficacy and safety of camrelizumab combination with
apatinib in female patients age of 18 to 70 with TNBC, and baseline tumor-infiltrating
lymphocytes > 10%. The number of patients to be included is 58 patients (Simon's two
stage design). The primary objective is to assess the pCR. All enrolled patients will be
treated with camrelizumab 200mg (iv. 3mg/kg for patient whose weight is below 50kg) on
day 1 of each 21-day cycle, and apatinib 250mg daily (po, d1-d21).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients sign the written informed consent.
2. Women aged 18-70.
3. Patients with histologically confirmed operable invasive breast cancer (T1cN1-2 or
T2-4N0-2)［ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative（IHC-/+ or IHC++
and FISH/CISH-）］.
4. Percentage of tumor-infiltrating lymphocytes >10% in baseline breast tumor.
5. Patients with at least one measuring lesion that was conformed to RECIST v1.1
standard.
6. No previous breast cancer-related treatment, including chemotherapy, immunotherapy,
endocrine therapy, radical surgery, or radiotherapy.
7. Patients can swallow pills.
8. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
9. Patients with a life expectancy of at least 12 weeks.
10. The patient's blood test results prior to enrollment met the following criteria： •
Hb≥90g/L; • Plt≥100^9/L; • Serum albumin ≥3g/dL; • Neutrophils≥1.5^9/L;
• TSH≤ normal upper limit (ULN);
- ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);
- TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis
subjects);
- ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);
- AKP≤ 2.5 ULN;
- Renal function within 7 days before the first administration: serum creatinine
≤1.5 ULN or creatinine clearance ≥60mL/min.
11. Female subjects of childbearing potential must have a negative serum pregnancy test
within 7 days before the first dose and must be willing to use very efficient
barrier methods of contraception for the course of the study through 6 months after
the last dose of study treatment.
Exclusion Criteria:
1. Combination of other malignancies or previous malignancies other than breast cancer
within the last 5 years, except for basal cell carcinoma or flat cell carcinoma of
the skin or carcinoma in situ of the uterine cervix that has been adequately
controlled by treatment.
2. Those who are not suitable for immunotherapy in combination with active infection.
3. The combination of severe non-malignant disease that would affect patient compliance
or put the patient at risk.
4. Concomitant with other antineoplastic therapy or are participating in other clinical
trials.
5. Male breast cancer, bilateral breast cancer or inflammatory breast cancer.
6. Patients with dementia, mental abnormality or any mental illness that prevents
understanding of the informed consent form.
7. Patients with history of allergic reaction or contraindication to the use of any
drug component of this trial.
8. Patients with any active autoimmune disease or a history of autoimmune disease
(e.g., the following, but not limited to: autoimmune hepatitis, interstitial
pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis,
nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or whose asthma
has completely resolved in childhood and does not require any intervention in
adulthood may be included; (Patients with asthma that requires medical intervention
with bronchodilators cannot be included).
9. Have cardiac clinical symptoms or disease that are not well controlled, such as:
(1) NYHA class 2 or higher heart failure; (2) Unstable angina pectoris; (3) Myocardial
infarction within 1 year; (4) clinically significant supraventricular or ventricular
arrhythmias requiring treatment or intervention.
10. Urine routine suggestive of urine protein ≥++, or confirmed 24-hour urine protein
amount ≥1.0g.
11. Known presence of hereditary or acquired bleeding and thrombotic tendencies (e.g.,
hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.).
12. Patients with congenital or acquired immune deficiencies (e.g., HIV-infected
individuals).
13. Live vaccines administered less than 4 weeks prior to study drug administration or
possibly during the study.
14. Active tuberculosis. 15. Patients have received oral or intravenous antibiotic
therapy within 2 weeks prior to neoadjuvant therapy.
16. Major surgical procedure within 4 weeks prior to the start of study treatment or
anticipated need for major surgical procedure during the course of the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Jieqiong Liu, M.D., Ph.D.
Facility:
Name:
Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
Address:
City:
Shanwei
Zip:
516600
Country:
China
Status:
Recruiting
Contact:
Last name:
Yandan Yao, M.D., Ph.D.
Email:
yaoyand@mail.sysu.edu.cn
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Zhou, M.D., Ph.D.
Email:
zhouwenbin@njmu.edu.cn
Facility:
Name:
Second Military Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Hengyu Li, M.D., Ph.D.
Email:
lhy@smmu.edu.cn
Start date:
December 1, 2022
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05556200
