Jindong Sheng, Haitao Luo, Xiangyu Liu, Chunyan Liu, Wenhao Zhou, Yujie Zhao, Ruoyan Liu, Dan Li, Changxiao Xu, Bo Yang, Ying Liu, Xin Fu, Lewen Bao, Ke Wang, Jihui Hao, Wenxin Liu
{"title":"Tislelizumab（抗pd -1）联合化疗作为IB3/IIA2期宫颈癌（NATIC）患者的新辅助治疗：一项前瞻性单臂II期研究","authors":"Jindong Sheng, Haitao Luo, Xiangyu Liu, Chunyan Liu, Wenhao Zhou, Yujie Zhao, Ruoyan Liu, Dan Li, Changxiao Xu, Bo Yang, Ying Liu, Xin Fu, Lewen Bao, Ke Wang, Jihui Hao, Wenxin Liu","doi":"10.1038/s41392-025-02294-9","DOIUrl":null,"url":null,"abstract":"<p><p>The clinical benefit of neoadjuvant immunochemotherapy in locally advanced cervical cancer (LACC) remains unclear. This single-arm, phase II study (Chinese Clinical Trial Registry, ChiCTR2200065392) aimed to evaluate the efficacy and safety of neoadjuvant anti-programmed cell death protein 1 (PD-1) antibody tislelizumab in combination with chemotherapy in treatment-naïve patients with stage IB3/IIA2 LACC. Enrolled patients received tislelizumab (200 mg, every 3 weeks) plus chemotherapy for 3 cycles before radical surgery. The primary endpoint was the pathological complete response (pCR). Secondary endpoints were objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1, disease-free survival, overall survival, and safety. Exploratory endpoints included tissue-based and blood-based biomarkers to identify the biological drivers behind the clinical outcomes. Between November 2022 and March 2024, 30 patients were enrolled. All patients completed 3 cycles of neoadjuvant immunochemotherapy and underwent radical surgery. The pCR was observed in 20 (66.7%) patients, and 4 (13.3%) patients achieved major pathological response (MPR), with an optimal pathological response rate (OPR) of 80.0%. The ORR was 90.0%, with 17 (56.7%) complete responses. Survival data were immature at the median follow-up of 14.7 months (data cutoff, December 31, 2024). Grade 3 treatment-related adverse events (TRAEs) and immune-related AEs occurred in 26.7% and 3.3% of patients, respectively. No treatment-related death occurred. Patients with pCR had significantly higher expression of PD-L1 CPS at baseline, and a strong relationship with immune-related signature (all p < 0.05). Neoadjuvant tislelizumab plus chemotherapy showed promising antitumor efficacy and a well-tolerated safety profile in patients with stage IB3/IIA2 LACC, and might be a potential option in this population.</p>","PeriodicalId":21766,"journal":{"name":"Signal Transduction and Targeted Therapy","volume":"10 1","pages":"215"},"PeriodicalIF":40.8000,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12227751/pdf/","citationCount":"0","resultStr":"{\"title\":\"Tislelizumab (anti-PD-1) plus chemotherapy as neoadjuvant therapy for patients with stage IB3/IIA2 cervical cancer (NATIC): a prospective, single-arm, phase II study.\",\"authors\":\"Jindong Sheng, Haitao Luo, Xiangyu Liu, Chunyan Liu, Wenhao Zhou, Yujie Zhao, Ruoyan Liu, Dan Li, Changxiao Xu, Bo Yang, Ying Liu, Xin Fu, Lewen Bao, Ke Wang, Jihui Hao, Wenxin Liu\",\"doi\":\"10.1038/s41392-025-02294-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The clinical benefit of neoadjuvant immunochemotherapy in locally advanced cervical cancer (LACC) remains unclear. This single-arm, phase II study (Chinese Clinical Trial Registry, ChiCTR2200065392) aimed to evaluate the efficacy and safety of neoadjuvant anti-programmed cell death protein 1 (PD-1) antibody tislelizumab in combination with chemotherapy in treatment-naïve patients with stage IB3/IIA2 LACC. Enrolled patients received tislelizumab (200 mg, every 3 weeks) plus chemotherapy for 3 cycles before radical surgery. The primary endpoint was the pathological complete response (pCR). Secondary endpoints were objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1, disease-free survival, overall survival, and safety. Exploratory endpoints included tissue-based and blood-based biomarkers to identify the biological drivers behind the clinical outcomes. Between November 2022 and March 2024, 30 patients were enrolled. All patients completed 3 cycles of neoadjuvant immunochemotherapy and underwent radical surgery. The pCR was observed in 20 (66.7%) patients, and 4 (13.3%) patients achieved major pathological response (MPR), with an optimal pathological response rate (OPR) of 80.0%. The ORR was 90.0%, with 17 (56.7%) complete responses. Survival data were immature at the median follow-up of 14.7 months (data cutoff, December 31, 2024). Grade 3 treatment-related adverse events (TRAEs) and immune-related AEs occurred in 26.7% and 3.3% of patients, respectively. No treatment-related death occurred. Patients with pCR had significantly higher expression of PD-L1 CPS at baseline, and a strong relationship with immune-related signature (all p < 0.05). Neoadjuvant tislelizumab plus chemotherapy showed promising antitumor efficacy and a well-tolerated safety profile in patients with stage IB3/IIA2 LACC, and might be a potential option in this population.</p>\",\"PeriodicalId\":21766,\"journal\":{\"name\":\"Signal Transduction and Targeted Therapy\",\"volume\":\"10 1\",\"pages\":\"215\"},\"PeriodicalIF\":40.8000,\"publicationDate\":\"2025-07-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12227751/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Signal Transduction and Targeted Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1038/s41392-025-02294-9\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"BIOCHEMISTRY & MOLECULAR BIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Signal Transduction and Targeted Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1038/s41392-025-02294-9","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
Tislelizumab (anti-PD-1) plus chemotherapy as neoadjuvant therapy for patients with stage IB3/IIA2 cervical cancer (NATIC): a prospective, single-arm, phase II study.
The clinical benefit of neoadjuvant immunochemotherapy in locally advanced cervical cancer (LACC) remains unclear. This single-arm, phase II study (Chinese Clinical Trial Registry, ChiCTR2200065392) aimed to evaluate the efficacy and safety of neoadjuvant anti-programmed cell death protein 1 (PD-1) antibody tislelizumab in combination with chemotherapy in treatment-naïve patients with stage IB3/IIA2 LACC. Enrolled patients received tislelizumab (200 mg, every 3 weeks) plus chemotherapy for 3 cycles before radical surgery. The primary endpoint was the pathological complete response (pCR). Secondary endpoints were objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1, disease-free survival, overall survival, and safety. Exploratory endpoints included tissue-based and blood-based biomarkers to identify the biological drivers behind the clinical outcomes. Between November 2022 and March 2024, 30 patients were enrolled. All patients completed 3 cycles of neoadjuvant immunochemotherapy and underwent radical surgery. The pCR was observed in 20 (66.7%) patients, and 4 (13.3%) patients achieved major pathological response (MPR), with an optimal pathological response rate (OPR) of 80.0%. The ORR was 90.0%, with 17 (56.7%) complete responses. Survival data were immature at the median follow-up of 14.7 months (data cutoff, December 31, 2024). Grade 3 treatment-related adverse events (TRAEs) and immune-related AEs occurred in 26.7% and 3.3% of patients, respectively. No treatment-related death occurred. Patients with pCR had significantly higher expression of PD-L1 CPS at baseline, and a strong relationship with immune-related signature (all p < 0.05). Neoadjuvant tislelizumab plus chemotherapy showed promising antitumor efficacy and a well-tolerated safety profile in patients with stage IB3/IIA2 LACC, and might be a potential option in this population.
期刊介绍：
Signal Transduction and Targeted Therapy is an open access journal that focuses on timely publication of cutting-edge discoveries and advancements in basic science and clinical research related to signal transduction and targeted therapy.
Scope: The journal covers research on major human diseases, including, but not limited to:
Cancer,Cardiovascular diseases,Autoimmune diseases,Nervous system diseases.
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