Status:
COMPLETED
Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in NACT for Locally Advanced Cervical Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Cervical Cancer
Chemotherapy Effect
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
To determine the safety and efficacy of Sindilimab combined with Paclitaxel and Cisplatin in neoadjuvant chemotherapy for Locally Advanced Cervical Cancer
Detailed Description
A total of 47 patients will be enrolled in this study. After screening, patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles. CT/MR o...
Eligibility Criteria
Inclusion
- Patients aged 18 to 65 years with primary cervical cancer;
- Clinical diagnosis of cervical cancer stage IB3 or IIA2 (FIGO stage, 2018). The stage was determined by two associate senior physicians or above after examining the patients;
- no distant organ metastasis, and the short diameter of retroperitoneal lymph nodes was less than 1 cm;
- according to the RECIST version 1.1 criteria, the measurable lesion of the cervix assessed by imaging was \> 3.5 cm;
- histological types includes cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma;
- no radiotherapy, chemotherapy or targeted therapy before;
- the expected survival time was greater than 3 months;
- the ECOG score of the Eastern Cooperative Oncology Group was 0 - 1;
- the function of important organs met the requirements of surgery, chemotherapy and radiotherapy.
Exclusion
- Patients with other malignant tumors;
- Patients is pregnancy or in perinatal period;
- Patients with myocardial infarction or stroke, or unstable angina pectoris, decompensated heart failure, or deep venous thrombosis;
- Patients with NCI-CTCAE 5.0 ≥ grade 2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
- Patients with active pneumonia: hepatitis patients with progressive loss of appetite, general weakness, nausea, acid reflux, anorexia, abdominal distension and other clinical manifestations, abnormal liver function and jaundice such as yellow eyes, yellow urine and other clinical symptoms;
- Patients with liver dysfunction (aspartate/alanine aminotransferase \> 2.5 times the upper limit of the standard);
- Patients with renal insufficiency (serum creatinine \> 2 times the upper limit of the standard);
- History of chronic lung disease with restrictive respiratory dysfunction;
- History of important organ transplantation, history of immune diseases;
- History of severe mental illness, History of cerebral dysfunction;
- history of drug abuse or drug use;
- patients are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose \> 10 mg prednisone or other effective hormones), and continue to use 2 weeks before enrollment;
- coagulation abnormalities (INR \> 2.0, PT \> 16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin,Low molecular weight heparin;
- Congenital or acquired immunodeficiency (such as HIV infection);
- Received live vaccine within 30 days before the first dose;
- Unable or unwilling to sign the informed consent form or comply with the study requirements;
- Have a history, disease or laboratory abnormalities that may interfere with the test results or prevent the subject from participating in the study, or the investigator believes that participating in the study is not in the best benefit of the subject.
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04799639
Start Date
March 18 2021
End Date
June 24 2024
Last Update
June 25 2024
Active Locations (1)
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1
Sun Yat-sen University cancer center
Guangzhou, Guangdong, China, 510000