A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer

Prior treatment

• Concurrent Malignancy: History of other active malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin.
• Recent Anti-cancer Therapy: Any anti-cancer therapy (including chemotherapy, radical radiotherapy, hormonal therapy, biological therapy, or anti-cancer Chinese herbal medicine) within 4 weeks prior to the initiation of study treatment.
• Recent Major Surgery/Trauma: Major surgical procedure (excluding diagnostic biopsy) or significant traumatic injury within 4 weeks prior to the first dose of study drug, or anticipation of the need for major surgery during the study period.
• Prior Neurotoxicity: History of ≥ Grade 3 neurological adverse reactions attributed to prior anti-microtubule therapy.
• Severe Comorbidities: Any uncontrolled or severe concurrent medical condition that, in the investigator's judgment, would preclude participation, including but not limited to:
  • Severe cardiovascular or cerebrovascular disease.
  • Uncontrolled diabetes mellitus or hypertension.
  • Active severe infection.
  • Active peptic ulcer disease.
  • Uncontrolled psychiatric illness/disorder.

Other illness

• Hypersensitivity: Known or suspected hypersensitivity to any component of the study drugs or their excipients.
• General Exclusion: Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or compliance, or make the patient unsuitable for study participation.
• Contraindication to Steroids: Conditions for which corticosteroid use is contraindicated.

Other

• Symptomatic CNS Metastases: Patients with symptomatic central nervous system (CNS) metastases.
• Pregnancy/Lactation: Women who are pregnant or breastfeeding.

• Informed Consent: Patients must voluntarily sign an informed consent form prior to any study-related procedures.
• Age: Aged ≥18 years and ≤75 years.
• Diagnosis: Histologically or cytologically confirmed recurrent or metastatic cervical carcinoma.
• Performance Status: With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Measurable Disease: With at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Prior Therapy:
  • Patients must have received at least one line of standard systemic chemotherapy for recurrent/metastatic disease, OR
  • Patients with rapid disease progression (occurring within 6 months) during or after prior neoadjuvant or concurrent chemoradiotherapy.
• Treatment-Related Toxicity: Recovery from all toxicities related to prior anti-cancer therapies to ≤ Grade 1 (according to CTCAE v5.0). Patients with alopecia of any grade are eligible.
• Adequate Hematological Function (within 1 week prior to enrollment, per local laboratory reference ranges):
  • White blood cell count (WBC) ≥ 2.5 × 10⁹/L.
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L.
  • Platelet count (PLT) ≥ 100 × 10⁹/L.
  • Hemoglobin (Hb) ≥ 9.0 g/dL (transfusion or erythropoietin use is permitted to meet this criterion).
• Adequate Liver and Kidney Functions (within 1 week prior to enrollment, per local laboratory reference ranges):
  • Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases).
  • Calculated creatinine clearance (Ccr) ≥ 60 mL/min.
• Contraception: Patients of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days after the last dose of study treatment. A negative serum or urine pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment.
• Life Expectancy: Anticipated life expectancy of at least 12 weeks.
• Compliance: Patients must be able and willing to comply with the study protocol for treatment and follow-up.