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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Karelizumab combined with etoposide and cisplatin group | Experimental | The cycle dose should be strictly controlled according to the experimental design. The order of administration is as follows: Karelizumab → Cisplatin → Etoposide (with an interval of at least 30 minutes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1. | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The period between the onset of treatment and the observation of disease progression or the occurrence of death for any reason. | 6-month |
| Disease-free survival period |
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Inclusion Criteria:
1. Age: 18 years ≤ Age ≤ 75 years, female patient. 2. Patients with cervical neuroendocrine carcinoma confirmed by histopathology or cytology (if mixed type carcinoma, the composition of neuroendocrine carcinoma is>60%), whose FIGO stage is stage I-II, and who can be operated according to the gynecological examination of an experienced Chief physician.
3. According to the RECIST 1.1 standard, patients have at least one measurable diameter target lesion (tumor lesion CT scan length ≥ 10mm, lymph node lesion CT scan short diameter ≥ 15mm, scan layer thickness 5mm).
4. ECOG PS 0-1 points. 5. The estimated postoperative survival time is greater than 3 months. 6. The main organs function normally and meet the following standards:
The blood routine test must meet the following criteria: (no blood transfusion within 14 days)
Biochemical examination must meet the following standards:
BIL<1.5 times upper limit of normal value (ULN)
ALT and AST<2.5ULN, GPT ≤ 1.5 × ULN
Serum Cr ≤ 1ULN, endogenous creatinine clearance rate>60ml/min (Cockcroft Goult formula).
7. Not participating in other clinical studies before and during treatment.
8. Women of childbearing age must undergo a serum pregnancy study within 7 days before the first medication use, and the results should be negative. Female participants of childbearing age and male participants with partners of childbearing age must agree to contraception within 24 weeks after signing the informed consent form and the last administration of the study medication.
9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Hai Xin | Contact | 13805056536 | 63804657@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014594 | Uterine Neoplasms |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
After radical treatment (complete surgical removal of the tumor), there is no time for the disease to recur.
| 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. | 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. | 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. | 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. | 5 years |
| Disease control rate | The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1. | 6-month |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |