This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.
This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.Following this, patients achieving complete or partial response will proceed to radical surgery and adjuvant therapy, while those with stable or progressive disease, or considered unsuitable for surgery by gynecological oncologists, will transfer to concurrent chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Karelizumab:200 mg,ivgtt,D1,q3w; Cisplatin:75 mg/m2,ivgtt,D1,q3w; Etoposide:100 mg/m2,ivgtt,D1\~3,q3w
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGObjective Response Rate
The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
Time frame: 6-month
Progression-free survival
The period between the onset of treatment and the observation of disease progression or the occurrence of death for any reason.
Time frame: 6-month
Disease-free survival period
After radical treatment (complete surgical removal of the tumor), there is no time for the disease to recur.
Time frame: 6-month
1 year and 3 year overall survival rates
The proportion of patients who have survived for one and three years after comprehensive treatment.
Time frame: 1 year and 3 year
1-year and 3-year progression free survival rates
The probability that the patient's disease will not continue to worsen within one and three years.
Time frame: 1 year and 3 year
1-year and 3-year disease control rates
The proportion of patients with reduced or stable tumors within 1 and 3 years.
Time frame: 1 year and 3 year
Incidence rate of adverse events
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
Time frame: 5 years
Disease control rate
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The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
Time frame: 6-month