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

NCT ID: NCT07266350

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2030-12-30

Brief Summary

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.

Conditions

Cervical Cancer Metastatic; Cervical Cancer Recurrent

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

camrelizumab

Camrelizumab

Intervention Type: DRUG

200mg IV Q3W

Cohort 2

famitinib

Famitinib

Intervention Type: DRUG

20mg QD PO

Cohort 3

camrelizumab +famitinib

Camrelizumab

Intervention Type: DRUG

200mg IV Q3W

Famitinib

Intervention Type: DRUG

20mg QD PO

Cohort 4

camrelizumab+others

Camrelizumab

Intervention Type: DRUG

200mg IV Q3W

Cohort 5

famitinib+others

Famitinib

Intervention Type: DRUG

20mg QD PO

Cohort 6

camrelizumab+famitinib+others

Camrelizumab

Intervention Type: DRUG

200mg IV Q3W

Famitinib

Intervention Type: DRUG

20mg QD PO

Interventions

Camrelizumab

200mg IV Q3W

Intervention Type: DRUG

Famitinib

20mg QD PO

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Qi Zhou

OTHER

Sponsor Role: lead

Responsible Party

Qi Zhou

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

qi zhou

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital,

Central Contacts

Xingtao Long

Role: CONTACT

czll6545@126.com

023-65075696

Other Identifiers

CZLL2025-042-001

Identifier Type: -

Identifier Source: org_study_id