Cervical CancerPhase 3NCT04906993
Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer
A Phase 3 study testing camrelizumab； famitinib malate and platinum-based chemotherapy in people with Cervical Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- camrelizumab； famitinib malate and platinum-based chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2021to 31 May 2027
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 18-75 years (including 18 and 75 years, calculated based on the signing date of the informed consent)
- Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy
- No prior systemic anti-cancer therapy for recurrent/metastatic disease
- According to RECIST v1.1 criteria, the patient must have at least one measurable lesion
- Able to normally swallow drug tablets
- The organ function level is good
- Willing to participate and able to comply with research programme requirements
Who cannot join
- Has any malignancy <5 years prior to study entry.
- Known to have brain or meningeal metastasis
- Known to have autoimmune disease
- Received live vaccinations 4 weeks before randomization or during the study period
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer
This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
- Conditions
- Cervical Cancer
- Being tested
- camrelizumab； famitinib malate, platinum-based chemotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumab； famitinib malateDrug
Camrelizumab intravenously ; Famitinib Orally
platinum-based chemotherapyDrug
Physician's choice chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab combined with famitinib malate | Experimental | Not described Receives: Drug: camrelizumab； famitinib malate |
| platinum-based chemotherapy | Active comparator | Not described Receives: Drug: platinum-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
Measured: up to 2 years
Overall survival (OS)
Measured: up to 3 years
Secondary outcomes (7)
Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria
Measured: up to 2 years
Objective response rate (ORR) assessed based on RECIST V1.1 criteria
Measured: up to 2 years
Disease control rate (DCR) assessed based on RECIST V1.1 criteria
Measured: up to 2 years
Duration of response (DOR) assessed based on RECIST V1.1 criteria
Measured: up to 2 years
Time to response (TTR) assessed based on RECIST V1.1 criteria
Measured: up to 2 years
Time to treatment failure (TTF)
Measured: up to 2 years
Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start23 Jul 2021
- Primary completion10 Jun 2025
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906993
- Sponsor's protocol ID
- SHR-1210-III-329
- Status last verified
- Sep 2025
- First submitted
- 26 May 2021
- Last updated
- 9 Sep 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT04906993
- Acronym / sponsor ID
- SHR-1210-III-329
- Conditions
- Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 28 May 2021 (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 study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy
| Arm | Type | Receives |
|---|---|---|
| camrelizumab combined with famitinib malate | Experimental | Drug: camrelizumab； famitinib malate |
| platinum-based chemotherapy | Active comparator | Drug: platinum-based chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female aged 18-75 years (including 18 and 75 years, calculated based on the signing date of the informed consent)
- Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy
- No prior systemic anti-cancer therapy for recurrent/metastatic disease
- According to RECIST v1.1 criteria, the patient must have at least one measurable lesion
- Able to normally swallow drug tablets
Key exclusion criteria (4 listed)
- Has any malignancy <5 years prior to study entry.
- Known to have brain or meningeal metastasis
- Known to have autoimmune disease
- Received live vaccinations 4 weeks before randomization or during the study period
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 |
|---|---|---|
| camrelizumab； famitinib malateCamrelizumab intravenously ; Famitinib Orally | Drug | camrelizumab combined with famitinib malate |
| platinum-based chemotherapyPhysician's choice chemotherapy | Drug | platinum-based chemotherapy |
Primary outcome
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 3 years
7 secondary outcomes
Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria
Time frame: up to 2 years
Objective response rate (ORR) assessed based on RECIST V1.1 criteria
Time frame: up to 2 years
Disease control rate (DCR) assessed based on RECIST V1.1 criteria
Time frame: up to 2 years
Duration of response (DOR) assessed based on RECIST V1.1 criteria
Time frame: up to 2 years
Time to response (TTR) assessed based on RECIST V1.1 criteria
Time frame: up to 2 years
Time to treatment failure (TTF)
Time frame: up to 2 years
Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression
Time frame: up to 2 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 9 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing camrelizumab； famitinib malate and platinum-based chemotherapy in people with Cervical Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 9 Sep 2025.