A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for the Treatment of Cervical Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorQi Zhou

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Camrelizumab

    Drug

    200mg IV Q3W

  • Famitinib

    Drug

    20mg QD PO

Treatment groups

1,300 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 32 interventions
Group D: Cohort 41 intervention
Group E: Cohort 51 intervention
Group F: Cohort 62 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From the first administration to 30 days after the end of the medication

Secondary outcomes

1

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.

Time frame
from the initiation of monotherapy or combination regimens, per 6-8 weeks
2

overall survival

It is defined as the time from the start of the first treatment to death caused by any reason.

Time frame
From date of treatment until the date of date of death from any cause, assessed up to 3 years

Other outcomes

Locations

This trial has no 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: