Cervical CancerPhase 2NCT07627620
Camrelizumab Combined With Famitinib Malate and Chemotherapy for Treatment of Recurrent/ Metastatic Cervical Cancer
A Phase 2 study testing Camrelizumab, Famitinib Malate and Chemotherapy in people with Cervical Cancer, run by Hunan Cancer Hospital.
Trial summary
This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and 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 Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Mar 2029
- Phase
- Phase 2
- 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.
- Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma, adenocarcinoma or adenosquamous 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
- Has adequate organ function.
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- Willing to participate and able to comply with research programme requirements.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy of more than 3 months.
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.
- Known allergies and contraindications to the investigational drug or any of its components.
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
Official title: A Multi-Center Phase II Clinical Study of Camrelizumab Combined With Famitinib Malate and Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer
This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- Camrelizumab, Famitinib Malate, Chemotherapy
- Keywords
- Cervical Cancer, Chemotherapy, Camrelizumab, Famitinib malate
- 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.
CamrelizumabDrug
Intravenous (IV) on Day 1 of each cycle
Famitinib MalateDrug
Famitinib po qd
ChemotherapyDrug
Paclitaxel + cisplatin or carboplatin
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab combined with famitinib malate and chemotherapy | Experimental | Not described Receives: Drug: Camrelizumab; Drug: Famitinib Malate; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective Response Rate defined as the percentage of participants who have a complete response or a partial response (PR) per RECIST 1.1.
Measured: up to 2 years
Secondary outcomes (6)
Disease control rate (DCR)
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Measured: up to 2 years
Duration of response (DOR)
Duration of Response per RECIST 1.1.
Measured: Up to 2 years
Time to response (TTR)
TTR is defined as the time from the date of first dose until the date of first documented response per RECIST 1.1.
Measured: up to 2 years
Progression-free survival (PFS)
PFS is defied as time from the date of first dose to first documented of disease progression (RECIST1.1) or date of death.
Measured: Up to 2 years
Overall Survival (OS)
OS was defined as the time from the date of first dose until death due to any cause.
Measured: Up to 2 years
Safety
Incidence, type and severity of adverse events
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 posted4 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Mar 2029 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627620
- Sponsor's protocol ID
- MA-CervC-II-011
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Phase II Clinical Study of Camrelizumab Combined With Famitinib Malate and Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT07627620
- Acronym / sponsor ID
- MA-CervC-II-011
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Chemotherapy, Camrelizumab, Famitinib malate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 4 Jun 2026 (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 an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab combined with famitinib malate and chemotherapy | Experimental | Drug: Camrelizumab, Drug: Famitinib Malate, Drug: Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female aged 18-75 years.
- Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma, adenocarcinoma or adenosquamous 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 (5 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.
- Known allergies and contraindications to the investigational drug or any of its components.
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 |
|---|---|---|
| CamrelizumabIntravenous (IV) on Day 1 of each cycle | Drug | Camrelizumab combined with famitinib malate and chemotherapy |
| Famitinib MalateFamitinib po qd | Drug | Camrelizumab combined with famitinib malate and chemotherapy |
| ChemotherapyPaclitaxel + cisplatin or carboplatin | Drug | Camrelizumab combined with famitinib malate and chemotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
Objective Response Rate defined as the percentage of participants who have a complete response or a partial response (PR) per RECIST 1.1.
6 secondary outcomes
Disease control rate (DCR)
Time frame: up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Time to response (TTR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Safety
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 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Famitinib Malate and Chemotherapy in people with Cervical Cancer, run by Hunan Cancer Hospital.
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 9 inclusion and 5 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 4 Jun 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jie Tang (0731-89762071, tangjie@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 2 years). 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 4 Jun 2026.