Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFujian Cancer Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Karelizumab combined with etoposide and cisplatin

    Drug

    Karelizumab:200 mg,ivgtt,D1,q3w; Cisplatin:75 mg/m2,ivgtt,D1,q3w; Etoposide:100 mg/m2,ivgtt,D1\~3,q3w

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Karelizumab combined with etoposide and cisplatin groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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