Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer

Korábbi kezelés

• Participated in other clinical trials within 30 days before receiving the first dose of chemotherapy drugs or during the treatment period.
• Previously received any other anti-tumor treatment for cervical cancer.
• Concurrent diseases or abnormal test results that interfere with the subject's ability to receive anti-tumor treatment as judged by the investigator, such as the estimated inability of the subject to tolerate at least 2 cycles of neoadjuvant chemotherapy plus surgery or concurrent chemoradiotherapy, etc.
  • Participation in this study is deemed not conducive to the maximum benefit of the subject as judged by the investigator.

Más betegség

• Non-HPV-related cervical cancer.
• Patients with known allergies to the active ingredients of the study drugs or their excipients.
• Diagnosed with other malignant tumors in the past 5 years (except those judged to be cured by the investigator).
• Active infections requiring systemic treatment.
• Positive for human immunodeficiency virus (HIV) antibody.
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody.

Egyéb

• Needing to receive other anti-tumor treatments during the study treatment period.
• Peripheral neuropathy with a grade of ≥ 2 according to the NCI-CTCAE (Version 5.0).

• Aged ≥ 18 years and ≤ 70 years;
• Cervical cancer with pathological types being squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
• Staged IB3 or IIA2 according to the FIGO 2018 staging system, as assessed by the investigator;
• ECOG performance status of 0-2, or KPS score ≥ 70;
• Expected survival time of more than 3 months;
• Having at least one measurable lesion in accordance with RECIST 1.1;
• Laboratory test results meeting the following criteria without drug intervention:
  • Hemoglobin ≥ 90 g/dl, neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L;
  • Creatinine ≤ 1.5 times the upper limit of normal range;
  • Total bilirubin, alanine transaminase (ALT), and aspartate transaminase (AST) < 2 times the upper limit of normal;
• Postmenopausal, or reproductive-aged women who meet all the following conditions: non-lactating, not pregnant, and able to use effective contraceptive measures during the study treatment period;
• Voluntarily participating in this study and signing the informed consent form.