QL1706 in Patients With Recurrent and Metastatic Cervical Cancer Resistant to Prior PD-1/PD-L1 Antibody Therapy

Inclusion Criteria:

1. Patients with recurrent/metastatic cervical cancer who previously experienced failure of PD-1 blockade therapy;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Life expectancy ≥3 months;
4. At least one measurable lesion per RECIST v1.1:

   Non-lymph node lesion: Longest diameter ≥10 mm Lymph node lesion: Short-axis diameter ≥15 mm Note: Previously irradiated lesions must be outside radiation fields or demonstrate progression post-radiation.
5. Adequate organ function within 14 days prior to treatment:

   1. Absolute neutrophil count (ANC) ≥1.0×10⁹/L
   2. Hemoglobin ≥60 g/L
   3. Platelet count ≥50×10⁹/L
   4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN (≤5×ULN for hepatic metastasis)
   5. Serum creatinine ≤2×ULN
6. Reproductive requirements:

   1. Non-childbearing potential (surgically sterilized or postmenopausal) OR
   2. Women of childbearing potential:

   Negative serum pregnancy test within 7 days prior to enrollment Commitment to use double-barrier contraception throughout the study and for 180 days post-treatment
7. Ability to comply with scheduled visits, treatment plans, and laboratory tests;
8. Voluntarily signed written informed consent.

Exclusion Criteria:

1. Prior treatment with anti-PD-1/CTLA-4 bispecific antibodies;
2. Active autoimmune disease requiring systemic control with corticosteroids (≥10 mg/day prednisone equivalent) or immunosuppressants within 14 days prior to enrollment;
3. Clinically significant cardiovascular/cerebrovascular events within 6 months prior to treatment, including:

   1. Acute myocardial infarction
   2. Unstable angina
   3. Cerebrovascular accident
   4. Symptomatic arterial/venous thrombosis or ischemic cardiomyopathy
   5. Clinically significant ventricular arrhythmias (sustained VT, VF, torsades de pointes)
   6. NYHA Class III/IV heart failure
   7. QTcF ≥480 ms or congenital long QT syndrome
   8. LVEF \<50% or severe wall motion abnormality per echocardiography
   9. Uncontrolled hypertension (SBP \>160 mmHg or DBP \>100 mmHg)
   10. Other clinically significant arrhythmias (e.g., third-degree AV block);
4. Uncontrolled comorbidities potentially affecting protocol compliance:

   * Severe respiratory diseases (ILD, severe asthma)
   * Active infections:

     * HBV (HBsAg+ AND HBV-DNA \>500 IU/mL)
     * HCV (HCV-Ab+ AND HCV-RNA+)
     * HIV-Ab+
     * Active TB or systemic infections requiring treatment ≤14 days
   * GI perforation/fistula ≤6 months (exceptions: resolved surgically)
   * Clinically significant bleeding ≤1 month (hematemesis, hemoptysis, etc.)
   * Active diverticulitis, abdominal abscess, or bowel obstruction;
5. Other malignancies within 3 years (excluding cured BCC, superficial bladder Ca, DCIS, or papillary thyroid Ca);
6. Known immunodeficiency disorders;
7. History of allogeneic hematopoietic stem cell or solid organ transplantation (excluding corneal grafts);
8. Systemic infections requiring IV antibiotics \>7 days within 2 weeks prior to treatment;
9. Administration of live attenuated vaccines within 4 weeks before/after treatment;
10. Pregnancy or lactation;
11. Investigator-assessed ineligibility;
12. Concurrent participation in other clinical trials.