Cervical CancerPhase 2NCT06289062
Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
A Phase 2 study testing Camrelizumab, Cisplatin and Nab paclitaxel in people with Cervical Cancer and Neoadjuvant Chemoimmunotherapy, run by Tongji Hospital at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Cancer, Neoadjuvant Chemoimmunotherapy, Fertility Preservation
- What is being tested?
- Camrelizumab, Cisplatin and Nab paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 8 May 2024to 1 Dec 2030
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- Laboratory tests: white blood cell (WBC) ≥3. 5×109/L, Neutrophil (NEU) ≥1. 5×109/L, platelet (PLT) ≥100×109/L, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and blood urea nitrogen （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.
Who cannot join
- 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;
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- 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, Prothrombin time (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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Huaiwu, PhD, luhuaiwu@163.com
Huaiwu Lu, PhD
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Kezhen Li, 086-027-8362, tjkeke@126.com
Jing Chen, 086-027-8362, chenjing3223@126.com
About this study
Official title: 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, EFS and OS.
- Being tested
- Camrelizumab, Cisplatin, Nab paclitaxel, biopsy
- 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
Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery
CisplatinDrug
75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.
Nab paclitaxelDrug
260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.
biopsyProcedure or surgery
cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| NACI in FIGO ⅠB1 Cervical Cancer | Experimental | 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, human papillomavirus (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. Receives: Drug: Camrelizumab; Drug: Cisplatin; Drug: Nab paclitaxel; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response
Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis
Measured: At the end of the patient's treatment, up to 2 years.
Secondary outcomes (11)
The negative conversion of HPV
Proportion of patients with known HPV infection at screening who are HPV-negative after treatment
Measured: At the end of treatment, up to 2 years.
Pregnancy rate
the ratio of the number of women with a successful pregnancy to the total number of women who attempted to become pregnant
Measured: Until the end of the 5-year follow-up period, up to 7 years.
Miscarriage rate
the ratio of miscarriage events that occur during pregnancy in women who are pregnant
Measured: Until the end of the 5-year follow-up period, up to 7 years.
Live birth rate
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
Measured: Until the end of the 5-year follow-up period, up to 7 years.
Preterm birth rate
The preterm birth rate is the proportion of babies born at less than 37 weeks of gestation
Measured: Until the end of the 5-year follow-up period, up to 7 years.
Adverse Event
Adverse Effects of immunotherapy and chemotherapy
Measured: during the treatment, up to 5 years.
Number of Participants with surgical complications
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.
Measured: During and after the surgery, up to 2 years.
Patient Reported Outcomes (EORTC QLQ-C30)
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score
Measured: From enrollment to the end of the 5-year follow-up period. 5 years.
Patient Reported Outcomes (EORTC QLQ-CX24)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (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.
Measured: From enrollment to the end of the 5-year follow-up period. 5 years.
Event-free survival (EFS)
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 progressive disease (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.
Measured: Until the end of the 5-year follow-up period, up to 7 years.
Overall survival (OS)
the time from the start of enrollment to death from any cause
Measured: Until the end of the 5-year follow-up period, up to 7 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start8 May 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Women's Hospital School Of Medicine Zhejiang University, Third Military Medical University, Beijing Friendship Hospital, Sichuan Cancer Hospital and Research Institute, Tianjin Medical University, West China Second University Hospital, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Gansu Cancer Hospital, Zhejiang Cancer Hospital, Shengjing Hospital, Anhui Provincial Cancer Hospital
- Responsible party
- Principal investigator, Kezhen Li, Tongji Hospital
- Investigators
- Ding Ma, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289062
- Sponsor's protocol ID
- NACI-CERV-005
- Status last verified
- Nov 2024
- First submitted
- 19 Feb 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu Y, Chen S, Cheng H, Han Y, Sun C, Chen G, Chen J, Li K. Chemotherapy plus camrelizumab for fertility preservation (NACI-F) in FIGO stage IB1 cervical cancer: a multicenter, single-arm, phase 2 trial. J Gynecol Oncol. 2026 Apr 29. doi: 10.3802/jgo.2026.37.e98. Online ahead of print.
PubMed 42172490
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer
- ClinicalTrials.gov ID
- NCT06289062
- Acronym / sponsor ID
- NACI-CERV-005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Women's Hospital School Of Medicine Zhejiang University, Third Military Medical University, Beijing Friendship Hospital, Sichuan Cancer Hospital and Research Institute, Tianjin Medical University, West China Second University Hospital, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Gansu Cancer Hospital, Zhejiang Cancer Hospital, Shengjing Hospital, Anhui Provincial Cancer Hospital
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 1 Mar 2024 (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 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, EFS and OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NACI in FIGO ⅠB1 Cervical Cancer | Experimental | Drug: Camrelizumab, Drug: Cisplatin, Drug: Nab paclitaxel, Procedure: biopsyNeoadjuvant 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, human papillomavirus (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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
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 |
|---|---|---|
| CamrelizumabCamrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery | Drug | NACI in FIGO ⅠB1 Cervical Cancer |
| Cisplatin75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min. | Drug | NACI in FIGO ⅠB1 Cervical Cancer |
| Nab paclitaxel260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min. | Drug | NACI in FIGO ⅠB1 Cervical Cancer |
| biopsycone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy | Procedure or surgery | NACI in FIGO ⅠB1 Cervical Cancer |
Primary outcome
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
11 secondary outcomes
The negative conversion of HPV
Time frame: 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.
Miscarriage rate
Time frame: 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.
Preterm birth rate
Time frame: 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.
Number of Participants with surgical complications
Time frame: During and after the surgery, up to 2 years.
Patient Reported Outcomes (EORTC QLQ-C30)
Time frame: From enrollment to the end of the 5-year follow-up period. 5 years.
Patient Reported Outcomes (EORTC QLQ-CX24)
Time frame: 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.
Overall survival (OS)
Time frame: Until the end of the 5-year follow-up period, up to 7 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 5 Nov 2024.
- Derived from this study: PubMed 42172490Hu Y, Chen S, Cheng H, Han Y, Sun C, Chen G, Chen J, Li K. Chemotherapy plus camrelizumab for fertility preservation (NACI-F) in FIGO stage IB1 cervical cancer: a multicenter, single-arm, phase 2 trial. J Gynecol Oncol. 2026 Apr 29. doi: 10.3802/jgo.2026.37.e98. Online ahead of print.
- 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.
Ding Ma study chair
Tongji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Cisplatin and Nab paclitaxel in people with Cervical Cancer and Neoadjuvant Chemoimmunotherapy, run by Tongji Hospital at 2 sites 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Kezhen Li (086-027-8362, tjkeke@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (time frame: At the end of the patient's treatment, up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289062, which also lists 1 linked publication.
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 5 Nov 2024.