drugset / Trial / NCT04516616
Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Phase 2
Active not recruiting
85 enrolled
Huazhong University of Science and Technology
Army Medical University, China · collabChongqing University Cancer Hospital · collabFirst Affiliated Hospital of Chongqing Medical University · collabObstetrics & Gynecology Hospital of Fudan University · collabPeking University People's Hospital · collabQilu Hospital of Shandong University · collabThe First Affiliated Hospital of China University of Science and Technology (Anhui Provincial) · collabThe Second Affiliated Hospital of Harbin Medical University · collabTianjin Medical University General Hospital · collabWomen's Hospital School Of Medicine Zhejiang University · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-12-01
- Primary completion
- 2023-04-30
- Completion
- 2028-07-01
Publications
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 260 mg/m2 | Intravenous |