Cervical CancerNCT07466901
A Single-arm, Multicenter, Phase II Clinical Study of Camrelizumab Combined With Famitinib in Adjuvant Therapy After Radical Resection of Cervical Cancer
A study testing Camrelizumab and famotinib in people with Cervical Cancer and Radical Surgery, run by Jin LI at 1 site in China.
Trial summary
This study is a single-arm, open-label, multicenter, exploratory clinical trial aimed at observing and evaluating the efficacy and safety of camrelizumab combined with famitinib in the adjuvant treatment of cervical cancer patients after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer, Radical Surgery, Adjuvant Therapy
- What is being tested?
- Camrelizumab and famotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Aug 2030
- Phase
- Interventional
- 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
- Age: 18-75 years old, female;
- No prior systemic anti-tumor treatment (including chemotherapy, radiotherapy, or other investigational treatments);
- PD-L1 test result: CPS ≥ 1;
- Presence of measurable lesions at baseline according to RECIST 1.1 criteria;
- Pathological types: squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma;
- FIGO 2018 stage: IA, IB1-2, IIA1, IB3, IIA2;
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- ECOG PS: 0-1;
- Expected survival period > 3 months;
- Good function of major organs, meeting the following criteria:
- Blood routine examination (without blood transfusion or use of hematopoietic stimulating factors to correct the condition within 14 days): hemoglobin (Hb) ≥ 90g/L; absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelets (PLT) ≥ 90×10⁹/L;
- Biochemical examination: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (for patients with liver metastases, ≤ 5×ULN); serum total bilirubin (TBIL) ≤ 1.5×ULN (for subjects with Gilbert syndrome, ≤ 3×ULN); serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance ≥ 60mL/min;
- Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN;
- Urinalysis shows urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification should be < 1g;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
- Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study and within 6 months after the end of the study; serum or urine pregnancy test within 7 days before enrollment must be negative, and they must be non-lactating patients; male patients must agree to use contraceptive measures during the study and within 6 months after the end of the study;
- Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- Patients participating in other clinical trials at the same time, unless they are in an observational, non-interventional clinical study or the follow-up period of an interventional study;
- Subjects with rare histopathological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc.;
- Subjects who have had other malignant tumors within 3 years before enrollment, except for cervical cancer. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, breast carcinoma in situ, etc.;
- A history of allergic reactions, hypersensitivity reactions, or intolerance to antibody-based drugs; a history of significant allergies to drugs, food, or other substances;
- Those with no measurable lesions or unevaluable lesions;
- Having received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first dose;
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- Having received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first dose;
- Having active autoimmune diseases requiring systemic treatment within the past two years;
- Having a history of non-infectious pneumonia requiring systemic glucocorticoid treatment, a history of pneumonia, or a current history of interstitial lung disease;
- Having a history of immunodeficiency; positive HIV antibody test; currently receiving long-term systemic corticosteroids or other immunosuppressants;
- A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Subjects with evidence or history of thrombosis or obvious bleeding tendency within 2 months before the first administration of the study drug (bleeding > 30 mL within 2 months, with hematemesis, melena, hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks);
- Having uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; known HIV infection or AIDS history; active syphilis; active tuberculosis; active infection; uncontrolled hypertension, symptomatic cardiac insufficiency; active bleeding;
- Pregnant or lactating women;
- Active or uncontrolled severe infections (≥ CTCAE5.0 grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia, and unexplained fever > 38.5℃ before the first dose;
- A clear history of mental disorders (including epilepsy or dementia); or other conditions that the investigator deems inappropriate for participation in the study;
- Patients who the investigator judges are unlikely to comply with the study procedures, restrictions, and requirements must not participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai
Li Jin Doctor, fudanlijin@163.com, fudanlijin@163.com
About this study
This study is a single-arm, open-label, multicenter, exploratory clinical trial aimed at observing and evaluating the efficacy and safety of camrelizumab combined with famitinib in the adjuvant treatment of cervical cancer patients after surgery.
- Conditions
- Cervical Cancer, Radical Surgery, Adjuvant Therapy
- Being tested
- Camrelizumab, famotinib
- 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
200mg, intravenous drip for 0.5h, Q3W
famotinibDrug
10mg, oral administration, QD
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab combined with famotinib | Experimental | Camrelizumab combined with famitinib for adjuvant therapy after radical resection of cervical cancer Receives: Drug: Camrelizumab; Drug: famotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year disease-free survival rate
The proportion of cancer patients without recurrence, metastasis, or tumor-related death within 2 years after treatment, for evaluating short-term efficacy.
Measured: 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion31 Aug 2030 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin LI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin LI, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466901
- Sponsor's protocol ID
- GUARD-CC-ADJ
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available per require after approved by ethics broad
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Phase II Clinical Study of Camrelizumab Combined With Famitinib in Adjuvant Therapy After Radical Resection of Cervical Cancer
- ClinicalTrials.gov ID
- NCT07466901
- Acronym / sponsor ID
- GUARD-CC-ADJ
- Conditions
- Cervical Cancer, Radical Surgery, Adjuvant Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jin LIUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 12 Mar 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 a single-arm, open-label, multicenter, exploratory clinical trial aimed at observing and evaluating the efficacy and safety of camrelizumab combined with famitinib in the adjuvant treatment of cervical cancer patients after surgery.
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 famotinib | Experimental | Drug: Camrelizumab, Drug: famotinibCamrelizumab combined with famitinib for adjuvant therapy after radical resection of cervical cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age: 18-75 years old, female;
- No prior systemic anti-tumor treatment (including chemotherapy, radiotherapy, or other investigational treatments);
- PD-L1 test result: CPS ≥ 1;
- Presence of measurable lesions at baseline according to RECIST 1.1 criteria;
- Pathological types: squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma;
Key exclusion criteria (17 listed)
- Patients participating in other clinical trials at the same time, unless they are in an observational, non-interventional clinical study or the follow-up period of an interventional study;
- Subjects with rare histopathological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc.;
- Subjects who have had other malignant tumors within 3 years before enrollment, except for cervical cancer. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, breast carcinoma in situ, etc.;
- A history of allergic reactions, hypersensitivity reactions, or intolerance to antibody-based drugs; a history of significant allergies to drugs, food, or other substances;
- Those with no measurable lesions or unevaluable lesions;
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, intravenous drip for 0.5h, Q3W | Drug | camrelizumab combined with famotinib |
| famotinib10mg, oral administration, QD | Drug | camrelizumab combined with famotinib |
Primary outcome
2-year disease-free survival rate
Time frame: 2 years after treatment
The proportion of cancer patients without recurrence, metastasis, or tumor-related death within 2 years after treatment, for evaluating short-term efficacy.
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 12 Mar 2026.
- Individual participant dataSharing planned: No. Data is available per require after approved by ethics broad
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camrelizumab and famotinib in people with Cervical Cancer and Radical Surgery, run by Jin LI 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 16 inclusion and 17 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 12 Mar 2026. 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.
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 Jin Li Doctor (fudanlijin@163.com, fudanlijin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year disease-free survival rate (time frame: 2 years after treatment). 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 12 Mar 2026.