cervical cancer
Conditions
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Histologically confirmed cervical squamous cell carcinoma; 3. Stage IB3 or IIA2 according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, or Karnofsky performance score (KPS)>= 70; 5. Expected survival of more than 3 months; 6. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; 7. Adequate bone marrow function and adequate liver and renal function; 8. Patients with menopause, or patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative pregnancy test result, non-lactating women; 9. Patients volunteered to participate in the study and gave written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients participated in other clinical trials within 30 days before the first chemotherapy dose or during treatment; 2. Patients had received anticancer therapy for cervical cancer; 3. Patients required other anticancer therapy during the study treatment period; 4. Patients who are allergic or intolerant to active ingredients or excipients of investigational drugs; 5. Diagnosed with any other cancer within the past 5 years (except for cured cancer judged by the investigator); 6. Active infection requiring systemic treatment; 7. Human immunodeficiency virus-positive patients; 8. Positive for hepatitis B surface antigen or hepatitis C virus antibody; 9. Patients with grade >= 2 peripheral neuropathy (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0); 10. Patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator, for example, patients may be unable to tolerate at least 2 cycles of neoadjuvant chemotherapy or when achieved a complete response or partial response to neoadjuvant chemotherapy, patients are unable to receive surgery; 11. Patients could not gain the maximum benefit from this study judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life;Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactLingying Wu
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed