Evidence map›Paper›PMID 40597137›Full record

Trial reportBMC medicine2025

Long-term efficacy and updated survival outcomes of sintilimab plus anlotinib in patients with PD-L1-positive recurrent or metastatic cervical cancer.

Jing Liu, Chunyan Lan, Tongyu Liu, Qin Liu, Lele Chang, Lele Zang, Fei Zhu, Mingxuan Zhu, Huiqi Zhang, Yaxin Kang and 4 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Jing Liu *Department of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Chunyan Lan *Department of Gynecologic Oncology, Sun Yat-Sen University Cancer Centre, Guangzhou, 510000, China.
Tongyu Liu *Department of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Qin LiuDepartment of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Lele ChangDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Lele ZangDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Fei ZhuDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Mingxuan ZhuDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Huiqi ZhangDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Yaxin KangDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Yuqin WangDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Huaiwu LuDepartment of Gynecologic Oncology, Sun Yat-Sen Memorial Hospital, Guangzhou, 510000, China. luhuaiwu@mail.sysu.edu.cn.
Yang SunDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China. sunyang@fjmu.edu.cn.
Qin XuDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, No. 420, Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China. xuqin@fjmu.edu.cn.

Funding

the Fujian Cancer Hospital High-Level Talent Training Program 2024YNG09the Joint Funds for the innovation of science and Technology,Fujian province 2023Y9451the Joint Funds for the National Clinical Key Specialty Construction Program 2021the Major Scientific Research Program for Young and Middle-aged Health Professionals of Fujian Province, China 2022ZQNZD008the Natural Science Foundation of Fujian Province 2023J011273the Startup Fund for scientific research, Fujian Medical University 2020QH1233
6 · The paper itself

Abstract

backgroundOur phase 2 study has shown the efficacy and safety of sintilimab plus anlotinib as second- or later-line therapy in patients with programmed death-ligand 1 (PD-L1)-positive recurrent or metastatic cervical cancer who had failed prior chemotherapy. Here, we presented updated survival outcomes after a 3-year follow-up.

methodsPatients received a regimen comprising 200 mg of sintilimab administered once on day 1 and 10 mg of anlotinib once daily on days 1-14 every 3 weeks. Treatment was continued until disease progression or intolerable toxicity. Updated overall survival (OS) and duration of response (DoR) were reported. For patients who received subsequent treatment after progression on sintilimab plus anlotinib, the second progression-free survival (PFS2) and objective response rate on subsequent treatment (ORR2) were analyzed.

resultsBetween December 2019 and December 2020, a total of 42 patients were enrolled. As of July 12, 2024, the median follow-up duration was 47.2 months (range, 0.6-52.9). Median OS was 17.8 months (95% confidence interval [CI], 12.3-36.5) for 42 patients, and the median DoR was 13.2 months (95% CI, 8.2-41.8) for 23 patients with objective response. Median PFS2 was 23.6 months (95% CI, 12.5-29.8) and the ORR2 was 46.1% in 13 patients. Multivariate analysis identified PIK3CA mutation (hazard ratio = 3.43; 95% CI, 1.04-11.30; P = 0.043) as an independent prognostic factor for OS. The incidence of grade ≥ 3 treatment-related adverse events did not increase with extended follow-up.

conclusionsLong-term follow-up showed persistent antitumor activity and maintained safety of sintilimab plus anlotinib in pre-treated patients with PD-L1-positive advanced cervical cancer.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenIndolesNeoplasm Recurrence, LocalQuinolinesUterine Cervical NeoplasmsAdultAgedFemaleHumansMiddle AgedTreatment OutcomeanlotinibAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanIndolesQuinolinessintilimabAnlotinibCervical cancerPIK3CAProgrammed death-ligand 1Sintilimab

Identifiers

PMID40597137
PMCPMC12220564

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.