Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial
To explore the efficacy and tolerability of a platinum-based regimen combined with the PD-1 antibody toripalimab administered prior to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.
• 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.