A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for the Treatment of Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,300
- 主要终点
- safety according to CTCAE v5.0
研究概览
简要总结
This trial is a national multicenter, open-label, non-interventional study to observe and evaluate the safety and efficacy of monotherapy or combination regimens based on camrelizumab or famitinib in patients with cervical cancer.
This study included patients with cervical cancer who used monotherapy or combination regimens based on camrelizumab or famitinib. The administration regimens include but are not limited to camrelizumab monotherapy, camrelizumab in combination with mitinib, famitinib monotherapy, camrelizumab in combination with other treatment regimens selected by the investigator, camrelizumab in combination with mitinib and other treatment regimens selected by the investigator, and famitinib in combination with other treatment regimens selected by the investigator.
It is planned to include cervical cancer patients who have decided to be treated with monotherapy or combination regimens based on camrelizumab or famitinib before enrollment, with an estimated 1,300 cases.
According to the treatment plan received by the patients, after enrollment, they can be respectively placed in one of the following six cohorts:
Queue 1: Only receiving camrelizumab monotherapy
Queue 2: Only receiving famitinib monotherapy
Queue 3: Only combination therapy of camrelizumab and famitinib was received
Queue 4: Receiving camrelizumab in combination with other treatment regimens
Queue 5: Receiving famitinib in combination with other treatment regimens
Queue 6: Receiving camrelizumab and famitinib in combination with other treatment regimens
Data from the baseline period, treatment period and follow-up period were collected respectively according to the cohort category (prospective or retrospective) of the enrolled patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Sign the informed consent form and voluntarily join this study;
- •Patients with cervical cancer diagnosed by histopathology;
- •Receive treatment with monotherapy or combination regimens based on camrelizumab or famitinib;
- •It is necessary to agree to take effective contraceptive measures and avoid egg donation from the time of signing the informed consent form until 2 months after the last administration of camrelizumab, 3 months after the last administration of famitinib, or within the contraceptive period specified in the instructions of the last administration of other study drugs (whichever is longer).
- •If a patient has had menstruation but has not yet reached postmenopausal status (with no menstruation for a continuous period of ≥12 months and no other causes found except menopause), and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation or bilateral oophorectomy), the patient is considered to have fertility.
排除标准
- •There is already evidence indicating that the patient is a pregnant or lactating woman.
- •Currently participating in any research involving intervention measures outside of regular clinical practice;
- •The researcher determines other circumstances that are not suitable for inclusion in the study.
研究组 & 干预措施
Cohort 1
camrelizumab
干预措施: Camrelizumab (Drug)
Cohort 2
famitinib
干预措施: Famitinib (Drug)
Cohort 3
camrelizumab +famitinib
干预措施: Camrelizumab (Drug)
Cohort 3
camrelizumab +famitinib
干预措施: Famitinib (Drug)
Cohort 4
camrelizumab+others
干预措施: Camrelizumab (Drug)
Cohort 5
famitinib+others
干预措施: Famitinib (Drug)
Cohort 6
camrelizumab+famitinib+others
干预措施: Camrelizumab (Drug)
Cohort 6
camrelizumab+famitinib+others
干预措施: Famitinib (Drug)
结局指标
主要结局
safety according to CTCAE v5.0
时间窗: From the first administration to 30 days after the end of the medication
The safety of monotherapy or combination regimens based on camrelizumab or famitinib in patients with cervical cancer under real-world conditions. Per CTCAE v5.0, preferred term and grade will be documented.
次要结局
- real world ORR(from the initiation of monotherapy or combination regimens, per 6-8 weeks)
- overall survival(From date of treatment until the date of date of death from any cause, assessed up to 3 years)
研究者
Qi Zhou
doctor
Chongqing University Cancer Hospital