NCT05910177招募中2 期
A Single Arm, Exploratory Clinical Study on the Neoadjuvant Treatment of Neuroendocrine Cervix Carcinoma With Camrelizumab Combined With Etoposide and Cisplatin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years ≤ Age ≤ 75 years, female patient.
- •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.
- •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).
- •ECOG PS 0-1 points.
- •The estimated postoperative survival time is greater than 3 months.
- •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).
- •Not participating in other clinical studies before and during treatment.
- •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.
- •The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Karelizumab combined with etoposide and cisplatin (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 6-month
The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.
次要结局
- Progression-free survival(6-month)
- Disease-free survival period(6-month)
- 1-year and 3-year disease control rates(1 year and 3 year)
- 1 year and 3 year overall survival rates(1 year and 3 year)
- 1-year and 3-year progression free survival rates(1 year and 3 year)
- Incidence rate of adverse events(5 years)
- Disease control rate(6-month)
研究者
研究点 (1)
Loading locations...
相似试验
Enrolling By Invitation
2 期
the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With TrilaciclibNon-small Cell Lung CancerNCT06370416Henan Cancer Hospital41
招募中
早期 1 期
EGFR/B7H3 CAR-T on Lung Cancer and Triple Negative Breast CancerEGFR/ B7H3-positive Advanced Lung CancerEGFR/ B7H3-positive Advanced Triple-negative Breast CancerNCT05341492Second Affiliated Hospital of Guangzhou Medical University30
招募中
早期 1 期
DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIsLung CancerNCT06329908Zhen-Yu Ding20
尚未招募
2 期
Fluzopari Combined With Apatinib for the Neoadjuvant Treatment of Unresectable Ovarian CancerOvarian CancerNCT05597527Fujian Cancer Hospital35
尚未招募
1 期
Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung CancerNon-small Cell Lung CancerNCT05965102Second Affiliated Hospital of Guangzhou Medical University31