TNBCNCT07622836
A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.
A study testing Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapy in people with TNBC and Adjuvant Therapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer. After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TNBC, Adjuvant Therapy, Lymph Node Positive
- What is being tested?
- Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2026to 31 Dec 2030
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant voluntarily joins this study and signs the informed consent form.
- Female breast cancer participants aged ≥18 and ≤75 years, with a histologically or cytologically confirmed diagnosis of TNBC (IHC 0, IHC 1+, or IHC 2+/ISH-) based on the most recent biopsy or other pathological specimen, according to the latest ASCO/CAP guidelines. Patients with low ER or PR expression (1%-10%) may also be included in this study.
- Patients with high-risk TNBC (defined as lymph node-positive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Agree to provide intraoperatively obtained tumor histopathological specimens (FFPE, at least 5 sections) for biomarker testing.
- Expected survival ≥3 months.
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- Function of vital organs meets the following requirements (use of any blood components or cell growth factors within 14 days before the first dose is not allowed):
- Absolute neutrophil count ≥1.5×10⁹/L;
- Platelet count ≥100×10⁹/L;
- Hemoglobin ≥90 g/L;
- Serum albumin ≥30 g/L;
- Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should also be assessed; if FT3 and FT4 are within normal range, the patient may be enrolled);
- Serum total bilirubin ≤1.5×ULN;
- ALT and AST ≤2.5×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN;
- ALP ≤2.5×ULN (in patients with liver or bone metastases, ALP ≤5×ULN);
- Serum creatinine ≤1.5×ULN;
- International normalized ratio (INR) ≤1.5×ULN (not receiving anticoagulation therapy).
- Female participants who are not surgically sterilized or are of childbearing potential must use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment. Female participants of childbearing potential who are not surgically sterilized must have a negative serum or urine HCG test within 7 days before the first dose and must not be lactating.
Who cannot join
- Presence of any active autoimmune disease or history of autoimmune disease (e.g., including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism); however, participants with the following conditions are allowed to enroll: vitiligo, psoriasis, alopecia not requiring systemic treatment; well-controlled type I diabetes mellitus; hypothyroidism stable on hormone replacement; childhood asthma that has completely resolved and requires no intervention in adulthood; asthma requiring bronchodilators for medical intervention is excluded.
- Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
- History of severe hypersensitivity reaction to other monoclonal antibodies.
- Prior discontinuation of anti-PD-1/PD-L1 antibody therapy due to related toxicity.
- Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.
- History of CNS metastases or current central nervous system (CNS) metastases. Baseline imaging to rule out brain metastases is not mandatory. Patients with unknown CNS metastasis status but with any clinical signs suggestive of CNS metastases are eligible only if CT and/or MRI scans rule out CNS metastases.
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- Previous history of other malignancies (except for patients with non-melanoma skin cancer or carcinoma in situ of the cervix, who are eligible; patients with other prior malignancies must have been disease-free for at least 3 years).
- Hypertension poorly controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); achieving the above parameters with antihypertensive treatment is allowed. History of hypertensive crisis or hypertensive encephalopathy.
- Within 6 months before first dose, known history of unstable angina, myocardial infarction (MI), or chronic heart failure (CHF), or known history of clinically significant arrhythmia requiring antiarrhythmic therapy (except stable atrial fibrillation), or left ventricular ejection fraction <50%.
- Current thrombolytic or anticoagulant therapy; prophylactic use of low-dose aspirin or low-molecular-weight heparin is permitted.
- Presence of pleural effusion, ascites, or pericardial effusion requiring drainage; patients may be enrolled if clinically stable after drainage as assessed by the investigator.
- Arterial/venous thrombotic events occurring within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before start of study treatment.
- Major surgery (excluding diagnostic procedures) within 4 weeks before start of study treatment, or anticipated need for major surgery during the study.
- Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein >1.0 g.
- Prior radiotherapy (except palliative radiotherapy for bone lesions), chemotherapy, or surgery (except biopsy) with completion (last dose) less than 4 weeks before the first study dose; last dose of antibody therapy less than 4 weeks before first study dose; molecular targeted therapy (including oral targeted drugs from other clinical trials) less than 5 half-lives before first study dose, or adverse reactions from prior treatment (excluding alopecia) not recovered to ≤CTCAE grade 1.
- Active infection, unexplained fever ≥38.5°C within 7 days before dosing, or baseline white blood cell count >15×10⁹/L.
- Congenital or acquired immunodeficiency (e.g., HIV infection); hepatitis B surface antigen (HBsAg) positive with HBV DNA ≥2000 IU/mL; or hepatitis C virus antibody positive.
- Prior treatment with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or anti-CTLA-4.
- Receipt of live vaccine within 4 weeks before first study dose or possible vaccination during the study period.
- As judged by the investigator, any other condition that may affect the study results or cause forced premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including psychiatric illness) requiring concomitant treatment, severe laboratory abnormalities, or family/social factors that may affect patient safety.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Xiaoan Liu, +86 138 0517 0249, liuxiaoan@126.com
Xiaoan Liu
About this study
This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer.
After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17.
Read more
After completing treatment, participants will continue to undergo post-treatment safety follow-up and survival follow-up. For participants who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted after treatment ends.
After enrollment, safety assessments will be performed every 3 weeks, and imaging evaluations will be performed every 12 weeks (±7 days) until confirmed disease progression per RECIST v1.1, initiation of another new anti-cancer therapy, withdrawal of informed consent, or death, whichever occurs first.
Read the detailed description
This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer.
After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17.
After completing treatment, participants will continue to undergo post-treatment safety follow-up and survival follow-up. For participants who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted after treatment ends.
After enrollment, safety assessments will be performed every 3 weeks, and imaging evaluations will be performed every 12 weeks (±7 days) until confirmed disease progression per RECIST v1.1, initiation of another new anti-cancer therapy, withdrawal of informed consent, or death, whichever occurs first.
- Conditions
- TNBC, Adjuvant Therapy, Lymph Node Positive
- Being tested
- Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapy
- Keywords
- TNBC, QL1706
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapyDrug
After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17.
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT GROUP（QL1706 + AC-T ） | Experimental | After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17. Receives: Drug: Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival rate (DFS%)
The 3-year disease-free survival rate refers to the proportion of patients who, within a 3-year follow-up period from randomization or the start of treatment (e.g., after surgery or completion of chemotherapy), remain alive and free from disease, without disease recurrence, disease progression, or death from any cause in a clinical trial (typically in oncology research).
Measured: within a 3-year follow-up period
Secondary outcomes (1)
3-year distant disease-free survival rate (DDFS%)
The 3-year distant disease-free survival rate refers to the proportion of patients who, within a 3-year follow-up period from randomization or the start of treatment (e.g., after surgery or completion of adjuvant chemotherapy), remain alive and free from distant disease, without developing distant metastases (e.g., to bones, liver, lungs, brain, or other distant organs) or death from any cause in a clinical trial (typically in oncology research).
Measured: within a 3-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start5 Jun 2026 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Dec 2030 (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.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Liu Xiaoan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622836
- Sponsor's protocol ID
- QL-BC-QIBA-3039
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT07622836
- Acronym / sponsor ID
- QL-BC-QIBA-3039
- Conditions
- TNBC, Adjuvant Therapy, Lymph Node Positive
- Keywords
- TNBC, QL1706
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Jun 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.
This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer.
After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17.
After completing treatment, participants will continue to undergo post-treatment safety follow-up and survival follow-up. For participants who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted after treatment ends.
After enrollment, safety assessments will be performed every 3 weeks, and imaging evaluations will be performed every 12 weeks (±7 days) until confirmed disease progression per RECIST v1.1, initiation of another new anti-cancer therapy, withdrawal of informed consent, or death, whichever occurs first.
Detailed description
This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer.
After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17.
After completing treatment, participants will continue to undergo post-treatment safety follow-up and survival follow-up. For participants who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted after treatment ends.
After enrollment, safety assessments will be performed every 3 weeks, and imaging evaluations will be performed every 12 weeks (±7 days) until confirmed disease progression per RECIST v1.1, initiation of another new anti-cancer therapy, withdrawal of informed consent, or death, whichever occurs first.
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（QL1706 + AC-T ） | Experimental | Drug: Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapyAfter enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The participant voluntarily joins this study and signs the informed consent form.
- Female breast cancer participants aged ≥18 and ≤75 years, with a histologically or cytologically confirmed diagnosis of TNBC (IHC 0, IHC 1+, or IHC 2+/ISH-) based on the most recent biopsy or other pathological specimen, according to the latest ASCO/CAP guidelines. Patients with low ER or PR expression (1%-10%) may also be included in this study.
- Patients with high-risk TNBC (defined as lymph node-positive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Agree to provide intraoperatively obtained tumor histopathological specimens (FFPE, at least 5 sections) for biomarker testing.
Key exclusion criteria (22 listed)
- Presence of any active autoimmune disease or history of autoimmune disease (e.g., including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism); however, participants with the following conditions are allowed to enroll: vitiligo, psoriasis, alopecia not requiring systemic treatment; well-controlled type I diabetes mellitus; hypothyroidism stable on hormone replacement; childhood asthma that has completely resolved and requires no intervention in adulthood; asthma requiring bronchodilators for medical intervention is excluded.
- Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
- History of severe hypersensitivity reaction to other monoclonal antibodies.
- Prior discontinuation of anti-PD-1/PD-L1 antibody therapy due to related toxicity.
- Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.
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 |
|---|---|---|
| Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapyAfter enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17. | Drug | TREATMENT GROUP（QL1706 + AC-T ） |
Primary outcome
3-year disease-free survival rate (DFS%)
Time frame: within a 3-year follow-up period
The 3-year disease-free survival rate refers to the proportion of patients who, within a 3-year follow-up period from randomization or the start of treatment (e.g., after surgery or completion of chemotherapy), remain alive and free from disease, without disease recurrence, disease progression, or death from any cause in a clinical trial (typically in oncology research).
1 secondary outcome
3-year distant disease-free survival rate (DDFS%)
Time frame: within a 3-year follow-up period
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 3 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapy in people with TNBC and Adjuvant Therapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 18 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xiaoan Liu (+86 138 0517 0249, liuxiaoan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival rate (DFS%) (time frame: within a 3-year follow-up period). 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 3 Jun 2026.