💬In plain words
What the trial is, and whether it could suit you
Triple-negative breast cancer (TNBC) accounts for about 20% of breast cancers, is poorly differentiated, progresses rapidly, and frequently recurs, making it the subtype with the worst prognosis. Owing to the absence of actionable receptors on tumor cells, chemotherapy has historically been the mainstay of TNBC treatment.
With advances in basic research, more immune checkpoint inhibitors (ICIs) targeting distinct pathways have entered clinical use. Avellutolimab (QL1706) combines two engineered monoclonal antibodies-anti-PD-1 and anti-CTLA-4-in a fixed \~2:1 ratio. By blocking PD-1, it inhibits immune escape; by blocking CTLA-4, it relieves immune suppression and activates antitumor immunity. Preclinical studies show QL1706 has stronger antitumor activity than either anti-PD-1 or anti-CTLA-4 alone. Clinically, QL1706 monotherapy demonstrated notable efficacy as second-line therapy for a
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Female patients aged ≥18 and ≤70 years with newly diagnosed invasive breast cancer.
2. Triple-negative breast cancer (TNBC) with clinical stage cT2-T4 and cN0-cN3.
3. Unilateral disease.
4. No prior chemotherapy or immunotherapy for invasive breast cancer.
5. ECOG performance status of 0-1.
6. Adequate renal, hepatic, cardiovascular, and bone marrow function.
7. The patient voluntarily participates and signs the informed consent form.
8. According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, patients should have measurable tumor lesion.
9. Estimated life expectancy ≥6 months
10. Female subjects enrolled must be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during study treatment and for 6 months after the end of study treatment. The serum or urine pregnancy test within 7 days prior to enrollment must be negative, and the subject must not be breastfeeding.
11. Able to comply with study and follow-up procedures and willing to adhere to the visit schedule and the prohibitions and restrictions specified in the protocol.
Exclusion Criteria:
1. History of invasive malignant tumor within ≤5 years prior to signing the informed consent form, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
2. History of autoimmune disease;
3. Active hepatitis B or C virus infection, except for hepatitis B virus carriers or patients stabilized after antiviral therapy, who may be enrolled if HBV DNA titer is ≤500 IU/mL or \<2500 copies/mL. Active hepatitis C is defined as known HCV antibody positivity with a known HCV RNA quantitative result above the lower limit of detection of the assay.
4. Presence of any active infection requiring systemic therapy.
5. Currently using corticosteroids or immunosuppressive agents.
6. Prior treatment with immune checkpoint inhibitors.
7. Presence of psychiatric disorders or other conditions that may affect patient compliance.
8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
9. Pregnant or breastfeeding female patients.
10. Known allergy to the investigational drugs used in this study or their components.
11. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this clinical trial.
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