TNBCNCT07491822
A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer
A study testing treatment group in people with TNBC, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
Camrelizumab + Chemoradiotherapy for Early TNBC Sponsor/Leading Center: Tianjin Medical University Cancer Institute and Hospital Study Type: Single-arm, single-center, Phase Ⅱ clinical study Planned Enrollment: 43 patients Eligible Population 18-75-year-old female patients with newly diagnosed, untreated early… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- TNBC
- What is being tested?
- treatment group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2026to 15 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years and ≤75 years with treatment-naive breast cancer;
- Histopathologically confirmed early-stage triple-negative invasive breast cancer as defined by the latest ASCO/CAP guidelines, meeting all of the following criteria: Pathological subtype must be triple-negative, specifically: ER-negative: IHC <1%, PR-negative: IHC <1%, HER2-negative: IHC 0/1+ or IHC 2+ but ISH-negative;
- Primary triple-negative breast cancer patients with clinical staging cT1c-T4d and any cN status;
- Center-assessed Ki67 and sTIL values;
- Expected survival ≥ 3 months;
- At least one measurable lesion present per RECIST 1.1 criteria;
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- Organ function levels must meet the following requirements: 1) Complete blood count (CBC) neutrophil count (ANC) ≥ 1.5 × 10⁹/L (no hematopoietic growth factor use within 14 days prior to first study dose); White blood cell count (WBC) ≥3.0×10⁹/L and ≤15×10⁹/L; lymphocyte count (LC) ≥0.5×10⁹/L; platelet count (PLT) ≥100×10⁹/L (no blood transfusion within 14 days prior to first study dose) Hemoglobin (Hb) ≥90 g/L; 2) Blood Biochemistry: TBIL ≤1.5×ULN; ALT and AST ≤2.5×ULN; ALP ≤2.5×ULN; BUN and Cr ≤1.5×ULN with creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); INR and APTT ≤ 1.5×ULN (without anticoagulant therapy); Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, assess T3 and T4 levels; inclusion permitted if T3 and T4 levels are normal; 3) Cardiac function: Echocardiogram: LVEF ≥ 50%; Lead ECG: QT interval, females < 470 ms.
- Contraception: Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to first dosing and agree to use a medically approved highly effective contraceptive method during the study and for 90 days after the last study drug administration. The investigator or designated personnel will select an appropriate contraceptive method for the subject and her partner from the options below after consultation, confirming the subject understands how to use it correctly and consistently. At the timepoints listed in the protocol, the investigator will notify the subject of the need for continuous, correct contraception. Additionally, the subject must be aware that they must immediately notify the investigator if they discontinue the selected contraceptive method or if they suspect or confirm pregnancy. A highly effective contraceptive method is one that, when used correctly and consistently alone or in combination with other methods, has an annual failure rate of less than 1%. These include the following: 1) Correct placement of an intrauterine device (IUD). 2) Condoms used in combination with a spermicide (i.e., foam, gel, film, cream, or suppository). 3) Bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion surgery (occlusion confirmed effective by relevant instrumentation). 4) Male vasectomy.
- Voluntarily enrolled in this study, signed informed consent, demonstrated good compliance, and agreed to participate in follow-up visits.
Who cannot join
- Tumor-Related Symptoms and Treatments
- Patients with metastatic breast cancer or bilateral breast cancer;
- Patients with inflammatory breast cancer;
- Received any antitumor therapy within 12 months prior to signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy, or tumor embolization;
- Previous treatment with PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other PD-1/PD-L1 inhibitors;
- Concurrent Diseases/Medical History
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- Active malignancies within 5 years prior to or concurrent with informed consent. Patients with cured localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, or cervical carcinoma in situ may be eligible.
- Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or patients not yet fully recovered from such procedures (tissue biopsies for diagnostic purposes and peripheral intravenous catheter placement for central venous access [PICC] are permitted);
- Subjects with any known or suspected autoimmune disease, except:
- Hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; Subjects with stable, well-controlled type 1 diabetes mellitus; 4) Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease (e.g., diabetes mellitus, pulmonary fibrosis, acute pneumonia); 5) History of live attenuated vaccine administration within 28 days prior to first study dose or anticipated live attenuated vaccine administration during the study period; 6) Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS); Hepatitis B Virus Surface Antigen (HBsAg) positive, or Hepatitis B Core Antibody (HBcAb) positive followed by positive HBV-DNA test (HBV-DNA testing only for HBsAg negative and HBcAb positive patients) ; positive HCV-RNA test following positive HCV antibody test (HCV-RNA testing only performed in HCV antibody-positive patients); autoimmune hepatitis; 7) Severe infection within 4 weeks prior to first dosing, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; or active infection of CTCAE ≥ Grade 2 requiring systemic antibiotic treatment within 2 weeks prior to first dosing; or unexplained fever >38.5°C during screening/prior to first dosing (fever attributable to tumor may be acceptable for enrollment at investigator's discretion) ; evidence of active tuberculosis infection within 1 year prior to dosing; 8) Subjects with a history of or scheduled for allogeneic bone marrow transplantation or solid organ transplantation; 9) Peripheral neuropathy ≥ Grade 2; 10) Severe cardiac disease or discomfort, including but not limited to: History of heart failure or systolic dysfunction (LVEF < 50%); high-risk uncontrolled arrhythmias such as atrial tachycardia; resting heart rate >100 bpm; significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher-degree atrioventricular block (i.e., Mobitz II second-degree AV block or third-degree AV block); coronary artery disease requiring antianginal medication; clinically significant valvular heart disease; ECG evidence of transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- Treatment-Related Exclusions
- ① Subjects who received systemic immunostimulatory agents (including but not limited to interferon or interleukin-2, including investigational immunostimulants) within 4 weeks prior to the first dose;
- ② Subjects who received systemic immunosuppressive therapy (including but not limited to glucocorticoids, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to the first dose. Excludes intranasal or inhaled corticosteroids or physiologically dosed systemic steroids (i.e., physiologically dosed corticosteroids not exceeding 10 mg/day of prednisone or equivalent);
- ③ Known allergy to the study drug or any of its excipients; or history of severe allergic reactions to other monoclonal antibodies;
- Pregnant or lactating women; women of childbearing potential with a positive baseline pregnancy test; or women of childbearing potential unwilling to use effective contraception throughout the study period.
- History of established neurological or psychiatric disorders, including epilepsy or dementia; subjects with known history of psychiatric drug abuse, alcoholism, or substance abuse;
- Any other condition deemed by the investigator to make the patient unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Camrelizumab + Chemoradiotherapy for Early TNBC Sponsor/Leading Center: Tianjin Medical University Cancer Institute and Hospital Study Type: Single-arm, single-center, Phase Ⅱ clinical study Planned Enrollment: 43 patients Eligible Population 18-75-year-old female patients with newly diagnosed, untreated early invasive triple-negative breast cancer (TNBC) (ER-/PR-/HER2- per ASCO/CAP guidelines), clinical stage cT1c-T4d (any cN); central assessment of Ki67 and sTIL values, at least one measurable lesion (RECIST 1.1), normal major organ function, expected survival ≥3 months; negative pregnancy test (women of childbearing potential) with agreement to effective contraception; signed informed consent and good compliance.
Exclusion: Metastatic/bilateral/inflammatory TNBC; prior anti-tumor/PD-1/PD-L1 treatment within 12 months; active other malignancies, autoimmune diseases, interstitial lung disease, uncontrolled severe infections/heart disease; pregnancy/lactation; allergy to study drugs.
Read more
Study Design Treatment Regimen (Neoadjuvant + Individualized Follow-up)
All patients receive the same combined therapy, followed by surgery (with extended treatment for non-responders):
12-week core neoadjuvant treatment: Camrelizumab (200mg IV, Q3W) + nab-paclitaxel (100mg/m² IV, weekly) + carboplatin (AUC=1 IV, weekly) + SBRT (10Gy × 2 sessions, on the 3rd day after chemotherapy in Week 3 and 6).
Post-12-week evaluation \& treatment:
Clinical responders: Undergo surgery within 3 weeks. Clinical non-responders: Continue with 12-week EC regimen (epirubicin 80mg/m² + cyclophosphamide 600mg/m², IV Q3W, 4 cycles) + camrelizumab, then surgery within 3 weeks.
Study Procedures Screening (≤28 days): Complete imaging, laboratory and physical examinations to confirm eligibility.
Treatment period: Scheduled combined therapy with regular efficacy assessments (breast imaging every 2 cycles) and safety monitoring.
Follow-up: Mandatory surgery after treatment; 90-day safety follow-up post-last dose, and long-term survival follow-up (q3m for Year 1, q6m thereafter) for 5 years.
Primary Outcome Pathological complete response (pCR, defined as ypT0/Tis ypN0: no residual invasive cancer in resected breast and sampled lymph nodes).
- Conditions
- TNBC
- Being tested
- treatment group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment groupDrug
- Albumin-bound paclitaxel;
- Carboplatin;
- Camrelizumab injection;
- Stereotactic Body Radiotherapy;
- Epirubicin;
- Cyclophosphamide;
- Surgery;
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | All enrolled patients will first receive 12 weeks of combination therapy with albumin-bound paclitaxel, carboplatin, and camrelizumab. Albumin-bound paclitaxel and carboplatin will be administered weekly. Additionally, two doses of 10 Gy stereotactic body radiation therapy (SBRT) will be delivered during weeks 3 and 6, respectively. Camrelizumab will be administered according to a 3-week dosing schedule. Following completion of this phase, clinical assessment based on MRI results was required. Patients achieving clinical response underwent surgery within 3 weeks. Those without clinical response continued the 12-week EC plus camrelizumab regimen (EC regimen: epirubicin plus cyclophosphamide). Receives: Drug: treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR(ypT0/Tis ypN0)
Following completion of neoadjuvant systemic therapy, no residual invasive carcinoma was detected in the completely resected breast specimen or in lymph nodes from all sampled regions.
Measured: through study completion, an average of 1 year.
Secondary outcomes (7)
PCR rate among ethnic minority populations
Measured: through study completion, an average of 1 year.
pCR rates based on different definitions of pCR (ypT0/is ypN0, ypT0 ypN0/+, ypT0/is ypN0/+, pCR with no restrictions on ypT and ypN0)
Measured: through study completion, an average of 1 year.
Objective Response Rate (ORR)
Measured: 18 to 24 weeks after the first dose
Breast-conserving surgery rate
Measured: 18 to 24 weeks after the first dose
Disease-free survival(DFS)
Measured: From the first dose until disease progression/recurrence/death, or up to 3 years after the first dose, whichever occurs first
Event-free survival(EFS)
Measured: From the first dose until disease progression/recurrence/death, or up to 3 years after the first dose, whichever occurs first
Overall survival(OS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start25 Mar 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491822
- Sponsor's protocol ID
- CEM-IPTNBC-01
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07491822
- Acronym / sponsor ID
- CEM-IPTNBC-01
- Conditions
- TNBC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Mar 2031 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Camrelizumab + Chemoradiotherapy for Early TNBC Sponsor/Leading Center: Tianjin Medical University Cancer Institute and Hospital Study Type: Single-arm, single-center, Phase Ⅱ clinical study Planned Enrollment: 43 patients Eligible Population 18-75-year-old female patients with newly diagnosed, untreated early invasive triple-negative breast cancer (TNBC) (ER-/PR-/HER2- per ASCO/CAP guidelines), clinical stage cT1c-T4d (any cN); central assessment of Ki67 and sTIL values, at least one measurable lesion (RECIST 1.1), normal major organ function, expected survival ≥3 months; negative pregnancy test (women of childbearing potential) with agreement to effective contraception; signed informed consent and good compliance.
Exclusion: Metastatic/bilateral/inflammatory TNBC; prior anti-tumor/PD-1/PD-L1 treatment within 12 months; active other malignancies, autoimmune diseases, interstitial lung disease, uncontrolled severe infections/heart disease; pregnancy/lactation; allergy to study drugs.
Study Design Treatment Regimen (Neoadjuvant + Individualized Follow-up)
All patients receive the same combined therapy, followed by surgery (with extended treatment for non-responders):
12-week core neoadjuvant treatment: Camrelizumab (200mg IV, Q3W) + nab-paclitaxel (100mg/m² IV, weekly) + carboplatin (AUC=1 IV, weekly) + SBRT (10Gy × 2 sessions, on the 3rd day after chemotherapy in Week 3 and 6).
Post-12-week evaluation \& treatment:
Clinical responders: Undergo surgery within 3 weeks. Clinical non-responders: Continue with 12-week EC regimen (epirubicin 80mg/m² + cyclophosphamide 600mg/m², IV Q3W, 4 cycles) + camrelizumab, then surgery within 3 weeks.
Study Procedures Screening (≤28 days): Complete imaging, laboratory and physical examinations to confirm eligibility.
Treatment period: Scheduled combined therapy with regular efficacy assessments (breast imaging every 2 cycles) and safety monitoring.
Follow-up: Mandatory surgery after treatment; 90-day safety follow-up post-last dose, and long-term survival follow-up (q3m for Year 1, q6m thereafter) for 5 years.
Primary Outcome Pathological complete response (pCR, defined as ypT0/Tis ypN0: no residual invasive cancer in resected breast and sampled lymph nodes).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: treatment groupAll enrolled patients will first receive 12 weeks of combination therapy with albumin-bound paclitaxel, carboplatin, and camrelizumab. Albumin-bound paclitaxel and carboplatin will be administered weekly. Additionally, two doses of 10 Gy stereotactic body radiation therapy (SBRT) will be delivered during weeks 3 and 6, respectively. Camrelizumab will be administered according to a 3-week dosing schedule. Following completion of this phase, clinical assessment based on MRI results was required. Patients achieving clinical response underwent surgery within 3 weeks. Those without clinical response continued the 12-week EC plus camrelizumab regimen (EC regimen: epirubicin plus cyclophosphamide). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients aged ≥18 years and ≤75 years with treatment-naive breast cancer;
- Histopathologically confirmed early-stage triple-negative invasive breast cancer as defined by the latest ASCO/CAP guidelines, meeting all of the following criteria: Pathological subtype must be triple-negative, specifically: ER-negative: IHC <1%, PR-negative: IHC <1%, HER2-negative: IHC 0/1+ or IHC 2+ but ISH-negative;
- Primary triple-negative breast cancer patients with clinical staging cT1c-T4d and any cN status;
- Center-assessed Ki67 and sTIL values;
- Expected survival ≥ 3 months;
Key exclusion criteria (17 listed)
- Tumor-Related Symptoms and Treatments
- Concurrent Diseases/Medical History
- Hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; Subjects with stable, well-controlled type 1 diabetes mellitus; 4) Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease (e.g., diabetes mellitus, pulmonary fibrosis, acute pneumonia); 5) History of live attenuated vaccine administration within 28 days prior to first study dose or anticipated live attenuated vaccine administration during the study period; 6) Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS); Hepatitis B Virus Surface Antigen (HBsAg) positive, or Hepatitis B Core Antibody (HBcAb) positive followed by positive HBV-DNA test (HBV-DNA testing only for HBsAg negative and HBcAb positive patients) ; positive HCV-RNA test following positive HCV antibody test (HCV-RNA testing only performed in HCV antibody-positive patients); autoimmune hepatitis; 7) Severe infection within 4 weeks prior to first dosing, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; or active infection of CTCAE ≥ Grade 2 requiring systemic antibiotic treatment within 2 weeks prior to first dosing; or unexplained fever >38.5°C during screening/prior to first dosing (fever attributable to tumor may be acceptable for enrollment at investigator's discretion) ; evidence of active tuberculosis infection within 1 year prior to dosing; 8) Subjects with a history of or scheduled for allogeneic bone marrow transplantation or solid organ transplantation; 9) Peripheral neuropathy ≥ Grade 2; 10) Severe cardiac disease or discomfort, including but not limited to: History of heart failure or systolic dysfunction (LVEF < 50%); high-risk uncontrolled arrhythmias such as atrial tachycardia; resting heart rate >100 bpm; significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher-degree atrioventricular block (i.e., Mobitz II second-degree AV block or third-degree AV block); coronary artery disease requiring antianginal medication; clinically significant valvular heart disease; ECG evidence of transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- Treatment-Related Exclusions
- ① Subjects who received systemic immunostimulatory agents (including but not limited to interferon or interleukin-2, including investigational immunostimulants) within 4 weeks prior to the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment group* Albumin-bound paclitaxel; * Carboplatin; * Camrelizumab injection; * Stereotactic Body Radiotherapy; * Epirubicin; * Cyclophosphamide; * Surgery; | Drug | Treatment group |
Primary outcome
pCR(ypT0/Tis ypN0)
Time frame: through study completion, an average of 1 year.
Following completion of neoadjuvant systemic therapy, no residual invasive carcinoma was detected in the completely resected breast specimen or in lymph nodes from all sampled regions.
7 secondary outcomes
PCR rate among ethnic minority populations
Time frame: through study completion, an average of 1 year.
pCR rates based on different definitions of pCR (ypT0/is ypN0, ypT0 ypN0/+, ypT0/is ypN0/+, pCR with no restrictions on ypT and ypN0)
Time frame: through study completion, an average of 1 year.
Objective Response Rate (ORR)
Time frame: 18 to 24 weeks after the first dose
Breast-conserving surgery rate
Time frame: 18 to 24 weeks after the first dose
Disease-free survival(DFS)
Time frame: From the first dose until disease progression/recurrence/death, or up to 3 years after the first dose, whichever occurs first
Event-free survival(EFS)
Time frame: From the first dose until disease progression/recurrence/death, or up to 3 years after the first dose, whichever occurs first
Overall survival(OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing treatment group in people with TNBC, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongsheng jia Tianjin Medical University Cancer Institute (13302019383, yongshengjia@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR(ypT0/Tis ypN0) (time frame: through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.