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

Primary Purpose

Carcinoma, Cervix Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Karelizumab combined with etoposide and cisplatin
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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) HB ≥ 100g/L WBC ≥ 3 × 109/L ANC ≥ 1.5 × 109/L PLT ≥ 100 × 109/L 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: 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. Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation. Accompanied by severe heart, lung, liver, and kidney diseases; Having neurological or mental illness; Individuals with jaundice or gastrointestinal obstruction and severe infections. Pregnant or lactating women. Suffering from coronary heart disease of grade I or above, arrhythmia (including prolonged QTc interval, female>470 ms), and cardiac dysfunction. Patients with abnormal coagulation function (INR>1.5, APTT>1.5 ULN). The subject has clinical cardiovascular symptoms or diseases that cannot be well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that are still poorly controlled without or after clinical intervention. Have a history of Interstitial lung disease (excluding radiation pneumonia without hormone treatment) and non infectious pneumonia. People who have been allergic to any component of Camrelizumab or any component of the study medication in the past. Researchers believe that it is not suitable for inclusion.

Sites / Locations

  • Fujian Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Karelizumab combined with etoposide and cisplatin group

Arm Description

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)

Outcomes

Primary Outcome Measures

Disease control rate
The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.

Secondary Outcome Measures

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.
1-year and 3-year disease control rates
The proportion of patients with reduced or stable tumors within 1 and 3 years.
Incidence rate of adverse events
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.

Full Information

First Posted
June 9, 2023
Last Updated
June 9, 2023
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05910177
Brief Title
Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Karelizumab Combined With Etoposide and Cisplatin
Official Title
A Single Arm, Exploratory Clinical Study on the Neoadjuvant Treatment of Neuroendocrine Cervix Carcinoma With Karelizumab Combined With Etoposide and Cisplatin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Cervix Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Karelizumab combined with etoposide and cisplatin group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Karelizumab combined with etoposide and cisplatin
Other Intervention Name(s)
Karelizumab
Intervention Description
Karelizumab:200 mg,ivgtt,D1,q3w; Cisplatin:75 mg/m2,ivgtt,D1,q3w; Etoposide:100 mg/m2,ivgtt,D1~3,q3w
Primary Outcome Measure Information:
Title
Disease control rate
Description
The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
Time Frame
6-month
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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
Title
Disease-free survival period
Description
After radical treatment (complete surgical removal of the tumor), there is no time for the disease to recur.
Time Frame
6-month
Title
1 year and 3 year overall survival rates
Description
The proportion of patients who have survived for one and three years after comprehensive treatment.
Time Frame
1 year and 3 year
Title
1-year and 3-year progression free survival rates
Description
The probability that the patient's disease will not continue to worsen within one and three years.
Time Frame
1 year and 3 year
Title
1-year and 3-year disease control rates
Description
The proportion of patients with reduced or stable tumors within 1 and 3 years.
Time Frame
1 year and 3 year
Title
Incidence rate of adverse events
Description
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) HB ≥ 100g/L WBC ≥ 3 × 109/L ANC ≥ 1.5 × 109/L PLT ≥ 100 × 109/L 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: 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. Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation. Accompanied by severe heart, lung, liver, and kidney diseases; Having neurological or mental illness; Individuals with jaundice or gastrointestinal obstruction and severe infections. Pregnant or lactating women. Suffering from coronary heart disease of grade I or above, arrhythmia (including prolonged QTc interval, female>470 ms), and cardiac dysfunction. Patients with abnormal coagulation function (INR>1.5, APTT>1.5 ULN). The subject has clinical cardiovascular symptoms or diseases that cannot be well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that are still poorly controlled without or after clinical intervention. Have a history of Interstitial lung disease (excluding radiation pneumonia without hormone treatment) and non infectious pneumonia. People who have been allergic to any component of Camrelizumab or any component of the study medication in the past. Researchers believe that it is not suitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Hai Xin
Phone
13805056536
Email
63804657@qq.com
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Hai Xin
Phone
13805056536
Email
63804657@qq.com

12. IPD Sharing Statement

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

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