About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial population
patients with confirmed cervical cancer
Trial design
Other
Prospective
Treatments tested in this trial
Camrelizumab
Drug200mg IV Q3W
Famitinib
Drug20mg QD PO
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
overall survival
It is defined as the time from the start of the first treatment to death caused by any reason.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Qi Zhou
Lead sponsor
Chongqing University Cancer Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: