- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06289062
Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
February 24, 2024 updated by: Kezhen Li, Tongji Hospital
Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer
This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, PFS and OS.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 2
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
- Name: Kezhen Li
- Phone Number: 086-027-8362
- Email: tjkeke@126.com
Study Contact Backup
- Name: Jing Chen
- Phone Number: 086-027-8362
- Email: chenjing3223@126.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Principal Investigator:
- Gang Chen
-
Contact:
- Kezhen Li
- Phone Number: 086-027-8362
- Email: tjkeke@126.com
-
Contact:
- Jing Chen
- Phone Number: 086-027-8362
- Email: chenjing3223@126.com
-
Principal Investigator:
- Kezhen Li
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Clinical diagnosis of stage IB1 cervical cancer after gynecologic examination and MRI evaluation by the investigator (FIGO 2018);
- Pathologically confirmed diagnosis of cervical squamous cell carcinoma;
- Transformation zone of TZ1 or TZ2 (IFCPC 2011);
- Positive PD-L1 expression by preoperative pathology, i.e., Combined Positive Score (CPS) ≥1;
- Patient age ≥18 years and ≤45 years;
- ECOG score ≤1;
- Laboratory tests: WBC ≥3. 5×109/L, NEU ≥1. 5×109/L, PLT ≥100×109/L, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and BUN and Cr ≤normal;
- Have a strong desire to give birth;
- Willing to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and program.
Exclusion Criteria:
- History of infertility, including those with infertility due to tubal or (and) husband;
- Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
- Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;
- History of human immunodeficiency virus (HIV) infection or known active hepatitis B or C;
- Use of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks prior to study dosing;
- History of primary malignancy or receipt of chemotherapy or pelvic radiation;
- Concurrent participation in other clinical trials;
- Pregnant or breastfeeding female patients; subjects must agree to use effective contraception during study treatment, within 5 months of last use of immune check inhibitors, within 6 months of last use of chemotherapeutic agents, and if there is no confirmation that the lesion has been removed or that the pathology is in remission;
- Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe/unstable angina pectoris, myocardial infarction within ≤ 6 months prior to study drug administration, severe arrhythmias requiring medication or intervention; difficult-to-control hypertension; and cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or those with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR > 2. 0, PT > 16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and any active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;
- Treatment with live or attenuated vaccine within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;
- Patients who have received a previous allogeneic bone marrow or solid organ transplant;
- Drug and/or alcohol abuse;
- Patients who, in the opinion of the investigator, are unlikely to comply with the study procedures, restrictions, and requirements may 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 |
Intervention / Treatment |
---|---|
Experimental: NACI in FIGO ⅠB1 Cervical Cancer
Neoadjuvant chemotherapy plus camrelizumab for ⅠB1 Cervical Cancer.
Patients first received one cycle of platinum-based doublet priming chemotherapy.
After 3 weeks, participants subsequently received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks.
The study will be conducted in two stages: (1) Patients enrolled in the first stage with tumors ≤2 cm and no new lesions after completion of treatment will undergo cone biopsy + pelvic lymphadenectomy or SLN mapping.
Those who meet ConCerv criteria will undergo a second TCT, HPV and colposcope 3 months later, and those who do not meet ConCerV criteria will undergo radical cervical surgery.
(2) Patients enrolled in the second stage with tumors ≤2 cm and no new lesions underwent cervical biopsy + pelvic lymphadenectomy or SLN mapping; patients with LSIL on biopsy underwent TCT, HPV, and colposcope 3 months later; if biopsy suggests HSIL and above, perform cone biopsy.
|
Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
75-80mg/m2, D1-D2,q3w (3 cycles),intravenous infusion, administered at a rate of 1mg/min.
260 mg/m2,D1,q3w (3 cycles),intravenous infusion, administered over 30min.
cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic complete response
Time Frame: At the end of the patient's treatment, up to 2 years.
|
Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis
|
At the end of the patient's treatment, up to 2 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The negative conversion of HPV
Time Frame: At the end of treatment, up to 2 years.
|
Proportion of patients with known HPV infection at screening who are HPV-negative after treatment
|
At the end of treatment, up to 2 years.
|
Pregnancy rate
Time Frame: Until the end of the 5-year follow-up period, up to 7 years.
|
the ratio of the number of women with a successful pregnancy to the total number of women who attempted to become pregnan
|
Until the end of the 5-year follow-up period, up to 7 years.
|
Miscarriage rate
Time Frame: Until the end of the 5-year follow-up period, up to 7 years.
|
the ratio of miscarriage events that occur during pregnancy in women who are pregnant
|
Until the end of the 5-year follow-up period, up to 7 years.
|
Live birth rate
Time Frame: Until the end of the 5-year follow-up period, up to 7 years.
|
The live birth rate is the ratio of the number of babies successfully delivered and surviving to the total number of women who attempted pregnancy
|
Until the end of the 5-year follow-up period, up to 7 years.
|
Preterm birth rate
Time Frame: Until the end of the 5-year follow-up period, up to 7 years.
|
The preterm birth rate is the proportion of babies born at less than 37 weeks of gestation
|
Until the end of the 5-year follow-up period, up to 7 years.
|
Adverse Event
Time Frame: during the treatment, up to 5 years.
|
Adverse Effects of immunotherapy and chemotherapy
|
during the treatment, up to 5 years.
|
Surgical complications
Time Frame: During and after the surgery, up to 2 years.
|
intraoperative bleeding, vascular injuries, bladder injuries, rectal injuries, and ureteral injuries, as defined by the need for suture repair; occlusive nerve injuries, as defined by complete severance; and vascular injuries, as defined by the need to document the site of injury.
Postoperative complications included: cervical stenosis, cervical insufficiency, ureteral/bladder/rectal/vaginal fistula, internal hemorrhage, pelvic infection, lymphocyst, lymphatic fistula, lower extremity edema, lower extremity venous thrombosis, urinary retention, nerve injury, and bowel obstruction.
|
During and after the surgery, up to 2 years.
|
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score
Time Frame: From enrollment to the end of the 5-year follow-up period. 5 years.
|
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score
|
From enrollment to the end of the 5-year follow-up period. 5 years.
|
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
Time Frame: From enrollment to the end of the 5-year follow-up period. 5 years.
|
The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments.
The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning.
The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment.
The change from baseline in EORTC QLQ-CX24 score will be presented.
|
From enrollment to the end of the 5-year follow-up period. 5 years.
|
Event-free survival (EFS)
Time Frame: Until the end of the 5-year follow-up period, up to 7 years.
|
the time between the enrollment and any documented tumor progression, recurrence, or death from any cause; the analysis of EFS includes the results of tumor evaluations during the study treatment and follow-up periods.
If a patient had several indicators of PD or recurrence, the EFS analysis was performed using the indicator that appeared first; PD, recurrence, or death were considered to have reached the study endpoint; patients who were treated with other systemic or antitumor therapies directed at the target lesion of observation were also considered to be in PD; for patients who did not have PD, recurrence, or death at the end of the study, the time when the patient's failure to have a recurrence was last obtained was used as the time to censor the data.
|
Until the end of the 5-year follow-up period, up to 7 years.
|
Overall survival (OS)
Time Frame: Until the end of the 5-year follow-up period, up to 7 years.
|
the time from the start of enrollment to death from any cause
|
Until the end of the 5-year follow-up period, up to 7 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Ding Ma, Tongji Hospital
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)
March 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2030
Study Registration Dates
First Submitted
February 19, 2024
First Submitted That Met QC Criteria
February 24, 2024
First Posted (Estimated)
March 1, 2024
Study Record Updates
Last Update Posted (Estimated)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 24, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- NACI-CERV-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on Camrelizumab
-
Shandong Provincial HospitalUnknown
-
Zhejiang Cancer HospitalUnknown
-
Zhejiang Cancer HospitalNot yet recruitingUterine Cervical Neoplasms | Oncolytic Virotherapy | CamrelizumabChina
-
Peking UniversityNot yet recruiting
-
Hebei Medical University Fourth HospitalRecruiting
-
Nanfang Hospital of Southern Medical UniversityRecruitingNasopharyngeal Carcinoma | Oligometastasis | RadiotherapyChina
-
Fudan UniversityRecruiting
-
Fujian Medical University Union HospitalRecruitingRadiotherapy | Immunotherapy | Esophageal NeoplasmChina
-
Cancer Institute and Hospital, Chinese Academy...Not yet recruiting
-
Henan Provincial People's HospitalNot yet recruiting