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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | camrelizumab |
| |
| Cohort 2 | famitinib |
| |
| Cohort 3 | camrelizumab +famitinib |
| |
| Cohort 4 | camrelizumab+others |
| |
| Cohort 5 | famitinib+others |
| |
| Cohort 6 | camrelizumab+famitinib+others |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 200mg IV Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety according to CTCAE v5.0 | 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. | From the first administration to 30 days after the end of the medication |
| Measure | Description | Time Frame |
|---|---|---|
| real world ORR | It is defined as the sum of the proportions of patients with complete response (CR) and partial response (PR) based on investigator assessment from the initiation of monotherapy or combination regimens based on camrelizumab or famitinib to disease progression/recurrence or the start of new anti-tumor treatment. | from the initiation of monotherapy or combination regimens, per 6-8 weeks |
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Inclusion Criteria:
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.
Exclusion Criteria:
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patients with confirmed cervical cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingtao Long | Contact | 023-65075696 | czll6545@126.com |
| Name | Affiliation | Role |
|---|---|---|
| qi zhou | Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, | Principal Investigator |
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| Famitinib | Drug | 20mg QD PO |
|
| overall survival | It is defined as the time from the start of the first treatment to death caused by any reason. | From date of treatment until the date of date of death from any cause, assessed up to 3 years |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C584390 | famitinib |
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