Evidence map›Paper›PMID 35623659›Full record

Trial reportJournal for immunotherapy of cancer2022

Phase II trial of efficacy, safety and biomarker analysis of sintilimab plus anlotinib for patients with recurrent or advanced endometrial cancer.

Wei Wei, Xiaohua Ban, Fan Yang, Jibin Li, Xiaqin Cheng, Rong Zhang, Xin Huang, Yongwen Huang, Qiaqia Li, Ya Qiu and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04157491 (A Single-center, Single-arm, Phase II Trial to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Recurrent or Advanced Endometrial Cancer), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 3% of its field
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.

NCT04157491 phase1 / phase2unknown statusnot on this map

A Single-center, Single-arm, Phase II Trial to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Recurrent or Advanced Endometrial Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2019 to 2022Enrolled23ConditionsEndometrial CancerArmsanlotinib and anti PD-1 antibody
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

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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

13 authors at 1 institution in 1 country.

Wei Wei *Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0001-5929-7409
Xiaohua Ban *State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Fan Yang *Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Jibin Li *State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Xiaqin Cheng *Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Rong ZhangState Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Xin HuangDepartment of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Yongwen HuangDepartment of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Qiaqia LiDepartment of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Ya QiuDepartment of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Min Zheng *Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Xiaofeng Zhu *State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Jundong Li *Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China lijd@sysucc.org.cn.
Sun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough co-inhibition of the angiogenesis and programmed death 1 (PD-1) pathways is proposed as an effective anticancer strategy, studies in Chinese patients with endometrial cancer are sufficient. Anlotinib is an oral multi-targeted tyrosine kinase inhibitor affecting tumor angiogenesis and proliferation; sintilimab is an anti-PD-1 monoclonal antibody.

methodsThis was a phase II trial using Simon's two-stage design. This study enrolled patients with endometrial cancer who had progressed after platinum-based chemotherapy. Sintilimab 200 mg was administered intravenously on day 1 every 3 weeks, and anlotinib 12 mg was administered on days 1-14 in a 21-day cycle. The primary endpoint was the objective response rate (ORR) using the immune-related Response Evaluation Criteria in Solid Tumors criteria. Immunohistochemistry and whole-exome sequencing were used as correlative investigations.

resultsBetween November 2019 and September 2020, 23 eligible patients were enrolled. The ORR and disease control rates were 73.9% (95% CI, 51.6 to 89.8) and 91.3% (95% CI, 72.0 to 98.9), respectively, with 4 complete and 12 partial responses. With a median follow-up of 15.4 months (95% CI, 12.6 to 18.3), the median progression-free survival was not reached, and the probability of PFS >12 months was 57.1% (95% CI, 33.6 to 75.0). Exploratory analysis revealed that mutations in the homologous repair pathway showed a trend for higher ORR (100% vs 0%, p=0.07). Treatment-related grade 3/4 adverse events were observed in 50.0% of the patients.

conclusionsSintilimab plus anlotinib demonstrated robust therapeutic benefits with tolerable toxicity in endometrial cancer. TRIAL REGISTRATION NUMBER: NCT04157491.

Indexed as

Endometrial NeoplasmsQuinolinesAntibodies, Monoclonal, HumanizedBiomarkersFemaleHumansIndolesanlotinibAntibodies, Monoclonal, HumanizedBiomarkersIndolesQuinolinessintilimabclinical trials, phase II as topicgenital neoplasms, femaleimmunotherapy

Identifiers

PMID35623659
PMCPMC9150151
OpenAlexW4281665682

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.