Overview

The main objective of this study is to determine whether neoadjuvant chemotherapy combined with slulimumab sequential concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced cervical cancer could improve progression-free survival rates.

Women in the experimental arm will receive neoadjuvant chemotherapy (cisplatin plus paclitaxel) combined with slulimumab every 21 days during 2 cycles followed by concurrent chemoradiation therapy. Women in the control arm will receive concurrent chemoradiation therapy alone.

286 patients will be recruited during 2 years, with 3 years of follow up period.

Eligibility

Inclusion Criteria:

• Age ≥18 years old
• Patients must have histologically confirmed cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 Ib3-IIIc2.
• According to the RECIST 1.1 standard, the subject must have at least one measurable target lesion
• No prior treatment
• Expected survival period ≥ 3 months
• ECOG score: 0-1
• No obvious signs of hematological diseases, ANC≥1.5×10^9/L, platelet count≥100×10^9/L, Hb≥90g/L, WBC≥3.0×10^9/L, and no bleeding tendency before enrollment;
• Adequate hepato-renal function is needed, including: Total bilirubin (TBIL)≤1.5×ULN (Gilbert syndrome allows ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN Serum creatinine (Cr) ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50mL/min
• Cardiac Function: left ventricular ejection fraction (LVEF) >=50%;
• Patients voluntarily participated in the study and signed informed consent

Exclusion Criteria:

• Pregnant or breastfeeding female patients (women of child-bearing potential must confirm that the pregnancy test is negative within 7 days before the first administration. If it is positive, ultrasound examination must be performed to exclude pregnancy), or women of child-bearing potential who refused to receive contraceptive measures
• Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part
• Existence of any bone marrow dysplasia and other abnormal hematopoietic diseases
• Active infections, HIV infections, and viral hepatitis that require systematic treatment
• Patients with≥Grade 1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 5.0
• Had severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug intervention within 6 months
• It is known to have a history of allergies to research drugs or drug components
• Has clinically significant thyroid dysfunction before enrollment;
• Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication
• Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent
• The investigator believes that the patient is not suitable for participating in this clinical research