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| ID | Type | Description | Link |
|---|---|---|---|
| NACI-CERV-001 | Other Identifier | Tongji Hospital, Tongji Medical College, HUST | |
| MA-CervC-II-002 | Other Identifier | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
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| Name | Class |
|---|---|
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
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Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. However, not all patients respond well to neoadjuvant chemotherapy. This is an open-label, single-arm, multi-center clinical trial to evaluate whether PD-1 in combination with neoadjuvant chemotherapy will achieve better objective response rate.
Subjects will receive therapy Q3W until evaluation of efficacy. The first cycle include cisplatin and albumin-bound paclitaxel. A combination of anti-PD-1 antibody (SHR-1210) with cisplatin and albumin-bound paclitaxel would be given in second and third cycles. Patients who have demonstrated complete or partial tumour responses (CR/PR)will receive surgery and receive postoperative adjuvant therapy in accordance with NCCN guideline. Patients who have demonstrated stable disease or progressive disease (SD/PD)will receive concurrent radiochemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Patients receive 1 cycle of cisplatin and albumin-bound paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of PD-1 antibody combined neoadjuvant chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles) | Drug | PD-1 monoclonal antibody (SHR-1210):200mg,IV infusion,Q3W Cisplatin:75-80 mg/m2, IV infusion, Q3W Albumin-bound paclitaxel: 260 mg/m2,30min,IV infusion, Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of the participants in the ITT population who have a Complete Response or Partial Response. The ORR will be assessed by a blind independent central reviewer per RECIST 1.1 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response rate | Pathological response rate is defined as the percentage of the participants in the ITT population who have complete pathologic remission or the infiltration depth of cervical lesions was < 3mm in histological examination. | 3 months |
| Event-free survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ding Ma, M.D., PhD | Tongji Hospital, Tongji Medical College, HUST | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38048802 | Derived | Li K, Chen J, Hu Y, Wang YZ, Shen Y, Chen G, Peng W, Fang Z, Xia B, Chen X, Song K, Wang Y, Zou D, Wang YC, Han Y, Feng X, Yuan J, Guo S, Meng X, Feng C, Chen Y, Yang J, Fan J, Wang J, Ai J, Ma D, Sun C. Neoadjuvant chemotherapy plus camrelizumab for locally advanced cervical cancer (NACI study): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Jan;25(1):76-85. doi: 10.1016/S1470-2045(23)00531-4. Epub 2023 Dec 1. | |
| 37985817 |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
5 years after completion of the study
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| First Affiliated Hospital of Chongqing Medical University |
| OTHER |
| Army Medical University, China | OTHER |
| Peking University People's Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Chongqing University Cancer Hospital | OTHER |
| The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial) | OTHER |
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|
EFS defined as the time interval from the date of participation to disease progression, local or distant recurrence (in patients undergoing surgery), or death due to any cause. |
| 5 years |
| Overall survival (OS) | OS is defined as the time from the date of participation until death. | 5 years |
| Derived |
| Fan J, Lu F, Qin T, Peng W, Zhuang X, Li Y, Hou X, Fang Z, Yang Y, Guo E, Yang B, Li X, Fu Y, Kang X, Wu Z, Han L, Mills GB, Ma X, Li K, Wu P, Ma D, Chen G, Sun C. Multiomic analysis of cervical squamous cell carcinoma identifies cellular ecosystems with biological and clinical relevance. Nat Genet. 2023 Dec;55(12):2175-2188. doi: 10.1038/s41588-023-01570-0. Epub 2023 Nov 20. |
| 37253491 | Derived | Chen J, Han Y, Hu Y, Feng X, Meng X, Guo S, Sun C, Chen G, Li K. Neoadjuvant camrelizumab plus chemotherapy for locally advanced cervical cancer (NACI Study): a study protocol of a prospective, single-arm, phase II trial. BMJ Open. 2023 May 30;13(5):e067767. doi: 10.1136/bmjopen-2022-067767. |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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