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

Sponsor
Qi Zhou
Study ID
NCT07266350
Status
Not Yet Recruiting

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Conditions

  • Cervical Cancer Metastatic
  • Cervical Cancer Recurrent

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200mg IV Q3W
  • Famitinib — DRUG
    20mg QD PO

Study Details

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.

Key Dates

Start date
Dec 30, 2025
Status verified
Dec 2025
Primary completion
Dec 30, 2028
Completion
Dec 30, 2030

Study Design

Enrollment
1,300 participants (estimated)

Arms

  • Arm: Cohort 1
    camrelizumab
  • Arm: Cohort 2
    famitinib
  • Arm: Cohort 3
    camrelizumab +famitinib
  • Arm: Cohort 4
    camrelizumab+others
  • Arm: Cohort 5
    famitinib+others
  • Arm: Cohort 6
    camrelizumab+famitinib+others

Primary Outcome Measure

safety according to CTCAE v5.0 [ Time Frame: From the first administration to 30 days after the end of the medication ]

Central Contacts

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