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| Name | Class |
|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
| Third Military Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The negative conversion of HPV | 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 | the ratio of the number of women with a successful pregnancy to the total number of women who attempted to become pregnant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kezhen Li | Contact | 086-027-8362 | tjkeke@126.com | |
| Jing Chen | Contact | 086-027-8362 | chenjing3223@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ding Ma | Tongji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42172490 | Derived | 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. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D002945 | Cisplatin |
| D013660 | Taxes |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Beijing Friendship Hospital |
| OTHER |
| Sichuan Cancer Hospital and Research Institute | OTHER |
| Tianjin Medical University | OTHER |
| West China Second University Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Gansu Cancer Hospital | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Shengjing Hospital | OTHER |
| Anhui Provincial Cancer Hospital | OTHER |
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| Cisplatin | Drug | 75-80mg/m2, D1-D2,q3w (3 cycles),intravenous infusion, administered at a rate of 1mg/min. |
|
| Nab paclitaxel | Drug | 260 mg/m2,D1,q3w (3 cycles),intravenous infusion, administered over 30min. |
|
| biopsy | Procedure | cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy |
|
| 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 | 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 | 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 | Until the end of the 5-year follow-up period, up to 7 years. |
| Adverse Event | Adverse Effects of immunotherapy and chemotherapy | 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. | 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 | 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. | 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. | 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 | Until the end of the 5-year follow-up period, up to 7 years. |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004467 |
| Economics |
| D004472 | Health Care Economics and Organizations |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |