induction chemotherapy combined with immunotherapy followed by concurrent chemoradiation in advanced cervical cancer

Conditions: Cervical Cancer

Summary: 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 criteria:
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