Cervical Cancer MetastaticPhase 2NCT07143292
A Prospective, Randomized, Parallel Trial of Famitinib Malate at Different Doses Combined With Camrelizumab for the Treatment of Recurrent and Metastatic Cervical Cancer
A Phase 2 study testing Famitinib + Camrelizumab in people with Cervical Cancer Metastatic and Cervical Cancer Recurrent, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
This study is a prospective, randomized, parallel investigation aimed at evaluating different doses of famitinib malate (20mg, 15mg, or 10mg, once daily, respectively) by analyzing the pharmacokinetics, efficacy, safety, and tolerability of famitinib malate combined with camrelizumab at different doses. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer Metastatic, Cervical Cancer Recurrent
- What is being tested?
- Famitinib + Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Jun 2028
- 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
- The subjects voluntarily joined this clinical study and signed the informed consent form, demonstrating good compliance, be able to cooperate with follow-up visits;
- Age: 18 to 75 years old (inclusive, calculated from the date of signing the informed consent);
- Cervical cancer confirmed by histopathology, including cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- It cannot be cured by surgery, radiotherapy or chemoradiotherapy;
- Those who have received platinum-based systemic therapy for recurrent/metastatic cervical cancer; The number of previous systemic treatment lines is ≤2;
- Has not received bevacizumab treatment in the past;
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- It can perform biopsies during the screening period and provide fresh tumor tissues for PD-L1 testing;
- According to the RECIST v1.1 standard, the patient must have at least one measurable lesion;
- ECOG score: 0-1 point;
- Be able to swallow pills normally;
- The expected survival period is ≥3 months;
- The functions of important organs should meet the standards.
Who cannot join
- History (within the past 5 years) or concurrent presence of other untreated malignant tumors, except for cured thyroid cancer, basal cell carcinoma, carcinoma in situ, and breast cancer that has been completely resected and has not recurred for more than 3 years;
- Individuals who have previously received famitinib or are allergic to other monoclonal antibodies;
- Individuals with any active, known autoimmune diseases;
- Participants who have received systemic treatment with corticosteroids (prednisone or other equivalent hormones at a dose >10 mg/day) or other immunosuppressive agents within the past 4 weeks. In the absence of active autoimmune disease, inhaled or topical corticosteroids, as well as adrenal hormone replacement therapy at a dose ≤10 mg/day of prednisone equivalent, are permitted;
- Known brain metastases or leptomeningeal metastases (excluding cases with brain metastases that have been stable for ≥4 weeks following radiotherapy or surgery);
- Imaging studies at screening showing tumor invasion of the bladder or rectum, with an assessed risk of perforation by the investigator;
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- Spontaneous vaginal bleeding >30 ml/day within 2 weeks prior to randomization, or visible tumors in the vagina, with a risk of bleeding as assessed by the investigator;
- Clinical symptoms of ascites or pleural effusion requiring drainage, or drainage of pleural or abdominal fluid within 2 weeks prior to randomization; excluding cases with imaging showing minimal ascites or pleural effusion without clinical symptoms;
- History or current presence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pulmonary inflammation (only radiologically demonstrated, those not requiring steroid treatment may be enrolled), drug-induced pneumonia, or active pneumonia during the screening period that the investigator determines precludes enrollment;
- Uncontrolled cardiac symptoms or conditions, such as: (1) NYHA Class 2 or higher heart failure; (2) unstable angina; (3) acute myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- Hypertension that is uncontrolled despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- Urinalysis indicating urine protein ≥2+, or quantitative urine protein testing confirming 24-hour urine protein quantification ≥1.0 g;
- Currently receiving thrombolytic/anticoagulant therapy, with prophylactic use of low-dose aspirin (≤100 mg/day) or low-molecular-weight heparin (≤40 mg/day);
- Patients who experienced any severe bleeding event of grade 2 or higher according to the CTCAE v5.0 criteria within 4 weeks prior to randomization;
- Patients with imaging evidence of tumor invasion into major vessels or those deemed by the investigator to have a high likelihood of tumor invasion into major vessels during treatment, potentially leading to life-threatening hemorrhage;
- Patients who have experienced intestinal obstruction or required parenteral nutrition within 1 month prior to randomization;
- Patients who have experienced arterial or venous thromboembolic events within 6 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, excluding lower extremity intermuscular venous thrombosis that, after assessment, does not require anticoagulant therapy, or thrombosis caused by catheter placement that has resolved and does not require medication;
- Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, etc.);
- Patients with radiation enteritis accompanied by bleeding symptoms, or those judged by the investigator to have a risk of risk of gastrointestinal perforation or bleeding;
- Patients who have undergone prior radiotherapy, chemotherapy, or tumor surgery, with less than 4 weeks elapsed from the completion of treatment (last dose) to randomization (for patients with bone metastasis, palliative radiotherapy to an area <5% of the bone marrow region may be permitted up to 2 weeks prior to randomization); or patients who have taken oral molecularly targeted drugs within 5 drug half-lives prior to randomization; or adverse reactions (excluding alopecia) that have not recovered to ≤ CTCAE v5.0 Grade 1;
- Subjects with active infections, or unexplained fever ≥ 38.5°C within 7 days prior to randomization, or those who have used antibiotics within 7 days prior to randomization;
- Subjects with congenital or acquired immune deficiencies (e.g., HIV-infected individuals); or active hepatitis (HBV reference: HBsAg positive and HBV DNA ≥ 500 IU/mL or 1000 copies/mL; for hepatitis C: HCV antibody positive and HCV RNA > upper limit of normal);
- Received a live vaccine within the previous 4 weeks or may receive one during the study period;
- The investigator determines that the subject has other factors that may lead to the study being terminated prematurely, such as severe concomitant diseases (e.g., severe diabetes, spinal cord compression, superior vena cava syndrome, mental illness), severe laboratory abnormalities, or family or social factors that may affect the subject's safety or the collection of data and samples;
- Severe non-healing wounds, ulcers, or fractures, or abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization.
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 study is a prospective, randomized, parallel investigation aimed at evaluating different doses of famitinib malate (20mg, 15mg, or 10mg, once daily, respectively) by analyzing the pharmacokinetics, efficacy, safety, and tolerability of famitinib malate combined with camrelizumab at different doses. The feasibility of continuously oral administration combined with camrelizumab in reducing the incidence of adverse events (especially grade ≥3 adverse events) in patients by dose reduction while maintaining comparable efficacy.
- Being tested
- Famitinib + Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Famitinib + CamrelizumabDrug
Famitinib + Camrelizumab
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Famitinib 20 mg QD PO + Camrelizumab 200 mg IV Q3W Receives: Drug: Famitinib + Camrelizumab |
| Arm 2 | Experimental | Famitinib 15 mg QD PO + Camrelizumab 200 mg IV Q3W Receives: Drug: Famitinib + Camrelizumab |
| Arm 3 | Experimental | Famitinib 10 mg QD PO + Camrelizumab 200 mg IV Q3W Receives: Drug: Famitinib + Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first
Measured: up to approximately 2 years
Secondary outcomes (1)
objective response rate per RECIST v1.1 by investigator
defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2028 (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.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Huaiwu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143292
- Sponsor's protocol ID
- MA-CervC-II-009
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel Trial of Famitinib Malate at Different Doses Combined With Camrelizumab for the Treatment of Recurrent and Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT07143292
- Acronym / sponsor ID
- MA-CervC-II-009
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Aug 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 study is a prospective, randomized, parallel investigation aimed at evaluating different doses of famitinib malate (20mg, 15mg, or 10mg, once daily, respectively) by analyzing the pharmacokinetics, efficacy, safety, and tolerability of famitinib malate combined with camrelizumab at different doses. The feasibility of continuously oral administration combined with camrelizumab in reducing the incidence of adverse events (especially grade ≥3 adverse events) in patients by dose reduction while maintaining comparable efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Famitinib + CamrelizumabFamitinib 20 mg QD PO + Camrelizumab 200 mg IV Q3W |
| Arm 2 | Experimental | Drug: Famitinib + CamrelizumabFamitinib 15 mg QD PO + Camrelizumab 200 mg IV Q3W |
| Arm 3 | Experimental | Drug: Famitinib + CamrelizumabFamitinib 10 mg QD PO + Camrelizumab 200 mg IV Q3W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subjects voluntarily joined this clinical study and signed the informed consent form, demonstrating good compliance, be able to cooperate with follow-up visits;
- Age: 18 to 75 years old (inclusive, calculated from the date of signing the informed consent);
- Cervical cancer confirmed by histopathology, including cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- It cannot be cured by surgery, radiotherapy or chemoradiotherapy;
- Those who have received platinum-based systemic therapy for recurrent/metastatic cervical cancer; The number of previous systemic treatment lines is ≤2;
Key exclusion criteria (25 listed)
- History (within the past 5 years) or concurrent presence of other untreated malignant tumors, except for cured thyroid cancer, basal cell carcinoma, carcinoma in situ, and breast cancer that has been completely resected and has not recurred for more than 3 years;
- Individuals who have previously received famitinib or are allergic to other monoclonal antibodies;
- Individuals with any active, known autoimmune diseases;
- Participants who have received systemic treatment with corticosteroids (prednisone or other equivalent hormones at a dose >10 mg/day) or other immunosuppressive agents within the past 4 weeks. In the absence of active autoimmune disease, inhaled or topical corticosteroids, as well as adrenal hormone replacement therapy at a dose ≤10 mg/day of prednisone equivalent, are permitted;
- Known brain metastases or leptomeningeal metastases (excluding cases with brain metastases that have been stable for ≥4 weeks following radiotherapy or surgery);
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 |
|---|---|---|
| Famitinib + CamrelizumabFamitinib + Camrelizumab | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
progression free survival
Time frame: up to approximately 2 years
PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first
1 secondary outcome
objective response rate per RECIST v1.1 by investigator
Time frame: up to approximately 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 18 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Famitinib + Camrelizumab in people with Cervical Cancer Metastatic and Cervical Cancer Recurrent, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 12 inclusion and 25 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 18 Nov 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.
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 Huaiwu Lu (+86 020-81332199, luhuaiwu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: up to approximately 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 18 Nov 2025.