Cervical Cancer MetastaticNCT07266350
A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for the Treatment of Cervical Cancer
An observational study of Cervical Cancer Metastatic and Cervical Cancer Recurrent, run by Qi Zhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Metastatic, Cervical Cancer Recurrent
- What is being tested?
- Camrelizumab and Famitinib
- Type of treatment
- Injection or infusion
- How many people
- 1,300 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with confirmed cervical cancer
Who may be able to join
- 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;
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Being tested
- Camrelizumab, Famitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
200mg IV Q3W
FamitinibDrug
20mg QD PO
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | camrelizumab Receives: Drug: Camrelizumab | |
| Cohort 2 | famitinib Receives: Drug: Famitinib | |
| Cohort 3 | camrelizumab +famitinib Receives: Drug: Camrelizumab; Drug: Famitinib | |
| Cohort 4 | camrelizumab+others Receives: Drug: Camrelizumab | |
| Cohort 5 | famitinib+others Receives: Drug: Famitinib | |
| Cohort 6 | camrelizumab+famitinib+others Receives: Drug: Camrelizumab; Drug: Famitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first administration to 30 days after the end of the medication
Secondary outcomes (2)
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.
Measured: from the initiation of monotherapy or combination regimens, per 6-8 weeks
overall survival
It is defined as the time from the start of the first treatment to death caused by any reason.
Measured: From date of treatment until the date of date of death from any cause, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qi Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi Zhou, Chongqing University Cancer Hospital
- Investigators
- qi zhou, Principal investigator, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266350
- Sponsor's protocol ID
- CZLL2025-042-001
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for the Treatment of Cervical Cancer
- ClinicalTrials.gov ID
- NCT07266350
- Acronym / sponsor ID
- CZLL2025-042-001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Qi ZhouUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Camrelizumabcamrelizumab |
| Cohort 2 | – | Drug: Famitinibfamitinib |
| Cohort 3 | – | Drug: Camrelizumab, Drug: Famitinibcamrelizumab +famitinib |
| Cohort 4 | – | Drug: Camrelizumabcamrelizumab+others |
| Cohort 5 | – | Drug: Famitinibfamitinib+others |
| Cohort 6 | – | Drug: Camrelizumab, Drug: Famitinibcamrelizumab+famitinib+others |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with confirmed cervical cancer
Key inclusion criteria (6 listed)
- 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;
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab200mg IV Q3W | Drug | Cohort 1, Cohort 3, Cohort 4, Cohort 6 |
| Famitinib20mg QD PO | Drug | Cohort 2, Cohort 3, Cohort 5, Cohort 6 |
Primary outcome
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.
2 secondary outcomes
real world ORR
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
qi zhou principal investigator
Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital,
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Metastatic and Cervical Cancer Recurrent, run by Qi Zhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingtao Long (023-65075696, czll6545@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety according to CTCAE v5.0 (time frame: From the first administration to 30 days after the end of the medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.