A Single-arm, Multicenter, Phase II Clinical Study of Camrelizumab Combined With Famitinib in Adjuvant Therapy After Radical Resection of Cervical Cancer

March 9, 2026 updated by: Jin LI
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: 18-75 years old, female;
  2. No prior systemic anti-tumor treatment (including chemotherapy, radiotherapy, or other investigational treatments);
  3. PD-L1 test result: CPS ≥ 1;
  4. Presence of measurable lesions at baseline according to RECIST 1.1 criteria;
  5. Pathological types: squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma;
  6. FIGO 2018 stage: IA, IB1-2, IIA1, IB3, IIA2;
  7. ECOG PS: 0-1;
  8. Expected survival period > 3 months;

  9. Good function of major organs, meeting the following criteria:

    1. 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;
    2. 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;
    3. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN;
    4. Urinalysis shows urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification should be < 1g;
    5. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
  10. 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;
  11. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

Exclusion Criteria:

  1. 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;
  2. Subjects with rare histopathological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc.;
  3. 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.;
  4. A history of allergic reactions, hypersensitivity reactions, or intolerance to antibody-based drugs; a history of significant allergies to drugs, food, or other substances;
  5. Those with no measurable lesions or unevaluable lesions;
  6. 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;
  7. Having received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first dose;
  8. Having active autoimmune diseases requiring systemic treatment within the past two years;
  9. Having a history of non-infectious pneumonia requiring systemic glucocorticoid treatment, a history of pneumonia, or a current history of interstitial lung disease;
  10. Having a history of immunodeficiency; positive HIV antibody test; currently receiving long-term systemic corticosteroids or other immunosuppressants;
  11. A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  12. 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);
  13. 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;
  14. Pregnant or lactating women;
  15. 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;
  16. A clear history of mental disorders (including epilepsy or dementia); or other conditions that the investigator deems inappropriate for participation in the study;
  17. Patients who the investigator judges are unlikely to comply with the study procedures, restrictions, and requirements must not participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: camrelizumab combined with famotinib
Camrelizumab combined with famitinib for adjuvant therapy after radical resection of cervical cancer
Drug: Camrelizumab
200mg, intravenous drip for 0.5h, Q3W
Drug: famotinib
10mg, oral administration, QD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jin LI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GUARD-CC-ADJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available per require after approved by ethics broad

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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