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

Korábbi kezelés

• Prior treatment with anti-PD-1/CTLA-4 bispecific antibodies;
• Active autoimmune disease requiring systemic control with corticosteroids (≥10 mg/day prednisone equivalent) or immunosuppressants within 14 days prior to enrollment;
• Systemic infections requiring IV antibiotics >7 days within 2 weeks prior to treatment;
• Administration of live attenuated vaccines within 4 weeks before/after treatment;
• Concurrent participation in other clinical trials.

Más betegség

• 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;
• Other malignancies within 3 years (excluding cured BCC, superficial bladder Ca, DCIS, or papillary thyroid Ca);
• Known immunodeficiency disorders;
• History of allogeneic hematopoietic stem cell or solid organ transplantation (excluding corneal grafts);

Laborértékek

• Clinically significant cardiovascular/cerebrovascular events within 6 months prior to treatment, including:
  • Acute myocardial infarction
  • Unstable angina
  • Cerebrovascular accident
  • Symptomatic arterial/venous thrombosis or ischemic cardiomyopathy
  • Clinically significant ventricular arrhythmias (sustained VT, VF, torsades de pointes)
  • NYHA Class III/IV heart failure
  • QTcF ≥480 ms or congenital long QT syndrome
  • LVEF <50% or severe wall motion abnormality per echocardiography
  • Uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg)
  • Other clinically significant arrhythmias (e.g., third-degree AV block);

Egyéb

• Pregnancy or lactation;
• Investigator-assessed ineligibility;

• Patients with recurrent/metastatic cervical cancer who previously experienced failure of PD-1 blockade therapy;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Life expectancy ≥3 months;
• 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.
• Adequate organ function within 14 days prior to treatment:
  • Absolute neutrophil count (ANC) ≥1.0×10⁹/L
  • Hemoglobin ≥60 g/L
  • Platelet count ≥50×10⁹/L
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN (≤5×ULN for hepatic metastasis)
  • Serum creatinine ≤2×ULN
• Reproductive requirements:
  • Non-childbearing potential (surgically sterilized or postmenopausal) OR
  • 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
• Ability to comply with scheduled visits, treatment plans, and laboratory tests;
• Voluntarily signed written informed consent.