About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The blood routine test must meet the following criteria: (no blood transfusion within 14 days)
HB ≥ 100g/L
WBC ≥ 3 × 109/L
ANC ≥ 1.5 × 109/L
Disqualifiers
Those who have a history of chemotherapy, radiation therapy, targeted drug therapy, or immunotherapy in the past.
Patients who have Contraindication to surgical treatment and chemotherapy or whose physical condition and organ function do not allow large abdominal surgery.
Distant metastasis.
Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, Uveitis, enteritis, hepatitis, hypophysitis, Vasculitis, Myocarditis, nephritis, Hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except for Vitiligo or recovered childhood asthma/allergy patients who do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin.
Trial design
Single group
Treatments tested in this trial
Karelizumab combined with etoposide and cisplatin
DrugKarelizumab:200 mg,ivgtt,D1,q3w; Cisplatin:75 mg/m2,ivgtt,D1,q3w; Etoposide:100 mg/m2,ivgtt,D1\~3,q3w
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate
The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
Secondary outcomes
Progression-free survival
The period between the onset of treatment and the observation of disease progression or the occurrence of death for any reason.
Disease-free survival period
After radical treatment (complete surgical removal of the tumor), there is no time for the disease to recur.
1 year and 3 year overall survival rates
The proportion of patients who have survived for one and three years after comprehensive treatment.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.