Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer

Laborértékek

• Tumor recurrence or distant metastasis at screening.
  • Active autoimmune disease requiring systemic therapy, or any chronic condition requiring long-term high-dose corticosteroids (≥10 mg/day prednisone or equivalent) or other immunosuppressive agents.
  • Systemic corticosteroids (>10 mg/day prednisone or equivalent) or any other immunosuppressive drugs within 14 days before first study dose or anticipated during the study.
  • Live-attenuated vaccination within 30 days before first dose or planned during the study.
  • Prior organ transplantation or known HIV infection.
  • Active hepatitis B (HBV DNA >2000 IU/mL or >10⁴ copies/mL, or HBsAg positive) or active hepatitis C (HCV RNA >10³ copies/mL); co-infection with both viruses is also excluded.
  • Prior therapy with any agent targeting PD-1, PD-L1, PD-L2, CD137, CTLA-4 (e.g., ipilimumab), or any other antibody or drug that modulates T-cell co-stimulation or checkpoint pathways.
  • Known hypersensitivity to monoclonal antibodies, fusion proteins, or any excipients in the investigational products.
  • History of another malignancy within the past 5 years, except adequately treated cervical carcinoma in situ, basal-cell carcinoma of the skin, or other localized malignancies considered cured.
  • Severe non-surgical comorbidity or acute infection.
  • Peripheral neuropathy > Grade 1 (NCI-CTCAE).
  • Inadequate hematologic or organ function:
  • WBC < 4.0 × 10⁹/L, ANC < 1.5 × 10⁹/L, platelets < 100 × 10⁹/L, Hb < 90 g/L
  • TBIL > 1.5 × ULN, ALT/AST > 2.5 × ULN, BUN > 1.5 × ULN, creatinine > 1.5 × ULN
  • Symptomatic brain metastases.
  • Clinically significant cardiac arrhythmias, myocardial ischemia, severe conduction block, heart failure, or severe valvular disease.
  • Severe bone-marrow failure.
  • Uncontrolled psychiatric illness.
  • Pregnant or lactating women.
  • Investigator-judged unsuitability for the trial.
  • Concurrent participation in another interventional clinical study.

• Women aged 18-75 years.
  • Histologically confirmed, previously untreated locally advanced cervical cancer of squamous, adenocarcinoma, or adenosquamous type.
  • At least one measurable lesion that has not received prior local therapy (non-nodal lesion ≥ 10 mm longest diameter or pathological lymph node ≥ 15 mm short axis, per RECIST 1.1).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  • Estimated life expectancy ≥ 6 months.
  • Investigator-assessed eligibility for concurrent chemoradiotherapy.
  • No clinically significant active bleeding.
  • Laboratory values: WBC > 4 × 10⁹/L; platelets > 100 × 10⁹/L.
  • No history of other malignancies.
  • Women of child-bearing potential must have a negative serum pregnancy test and use effective contraception throughout the study.
  • Written informed consent obtained prior to any study-related procedures.