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

Qi Zhou

Status: Not yet enrolling

Conditions: Cervical Cancer Metastatic; Cervical Cancer Recurrent

Treatments: Drug: Famitinib; Drug: Camrelizumab

Study type: Observational

Funder types: Other

Identifiers

NCT07266350

CZLL2025-042-001

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old;
2. Sign the informed consent form and voluntarily join this study;
3. Patients with cervical cancer diagnosed by histopathology;
4. Receive treatment with monotherapy or combination regimens based on camrelizumab or famitinib;
5. 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.

Exclusion criteria

1. There is already evidence indicating that the patient is a pregnant or lactating woman.
2. Currently participating in any research involving intervention measures outside of regular clinical practice;
3. The researcher determines other circumstances that are not suitable for inclusion in the study.

Trial design

1,300 participants in 6 patient groups

Cohort 1

Description:

camrelizumab

Treatment:

Drug: Camrelizumab

Cohort 2

Description:

famitinib

Treatment:

Drug: Famitinib

Cohort 3

Description:

camrelizumab +famitinib

Treatment:

Drug: Camrelizumab

Drug: Famitinib

Cohort 4

Description:

camrelizumab+others

Treatment:

Drug: Camrelizumab

Cohort 5

Description:

famitinib+others

Treatment:

Drug: Famitinib

Cohort 6

Description:

camrelizumab+famitinib+others

Treatment:

Drug: Camrelizumab

Drug: Famitinib