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

December 4, 2025 updated by: Qi Zhou

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with confirmed cervical cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
camrelizumab
Drug: Camrelizumab
200mg IV Q3W
Cohort 2
famitinib
Drug: Famitinib
20mg QD PO
Cohort 3
camrelizumab +famitinib
Drug: Camrelizumab
200mg IV Q3W
Drug: Famitinib
20mg QD PO
Cohort 4
camrelizumab+others
Drug: Camrelizumab
200mg IV Q3W
Cohort 5
famitinib+others
Drug: Famitinib
20mg QD PO
Cohort 6
camrelizumab+famitinib+others
Drug: Camrelizumab
200mg IV Q3W
Drug: Famitinib
20mg QD PO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
safety according to CTCAE v5.0
Time Frame: From the first administration to 30 days after the end of the medication
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.
From the first administration to 30 days after the end of the medication

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
real world ORR
Time Frame: from the initiation of monotherapy or combination regimens, per 6-8 weeks
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.
from the initiation of monotherapy or combination regimens, per 6-8 weeks
overall survival
Time Frame: From date of treatment until the date of date of death from any cause, assessed up to 3 years
It is defined as the time from the start of the first treatment to death caused by any reason.
From date of treatment until the date of date of death from any cause, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qi Zhou

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: qi zhou, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CZLL2025-042-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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