Evidence map›Paper›PMID 38755119›Full record

Trial reportSignal transduction and targeted therapy2024

Sintilimab (anti-PD-1 antibody) plus chidamide (histone deacetylase inhibitor) in relapsed or refractory extranodal natural killer T-cell lymphoma (SCENT): a phase Ib/II study.

Yan Gao, Haixia He, Xueping Li, Liling Zhang, Wei Xu, Ru Feng, Wenyu Li, Yin Xiao, Xinxiu Liu, Yu Chen and 14 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
–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

32 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  15. Molecular pathogenesis and evolving treatment landscape of extranodal NK/T-cell lymphoma.Proceedings of the Japan Academy. Series B, Physical and biological sciences · 2026
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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

24 authors.

Yan Gao *State Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Haixia He *Department of Radiation Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Xueping Li *Department of Hematology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Liling ZhangCancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Wei XuDepartment of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.ORCID 0000-0003-4208-7477
Ru FengDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Wenyu LiDepartment of Lymphoma, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Yin XiaoCancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Xinxiu LiuCancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Yu ChenDepartment of pathology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Xiaoxiao WangState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Bing BaiState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Huijing WuDepartment of Medical Oncology, Hubei Cancer Center, Wuhan, China.
Qingqing CaiState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0001-5447-3282
Zhiming LiState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0001-9730-9917
Jibin LiDepartment of Clinical Research, Sun Yat-sen University Cancer Center, Guanzhou, China.ORCID 0000-0001-7632-3648
Suxia LinDepartment of Pathology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Yanxia HeState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Liqin PingState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Cheng HuangState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Jiaying MaoState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Xiujin ChenState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Baitian ZhaoDepartment of Clinical Research, Sun Yat-sen University Cancer Center, Guanzhou, China.
Huiqiang HuangState Key Laboratory of Oncology in South China & Collaborative Innovation Center of Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China. huanghq@sysucc.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Anti-PD-1 antibodies are a favorable treatment for relapsed or refractory extranodal natural killer T cell lymphoma (RR-ENKTL), however, the complete response (CR) rate and the duration of response (DOR) need to be improved. This phase 1b/2 study investigated the safety and efficacy of sintilimab, a fully human anti-PD-1 antibody, plus chidamide, an oral subtype-selective histone deacetylase inhibitor in 38 patients with RR-ENKTL. Expected objective response rate (ORR) of combination treatment was 80%. Patients received escalating doses of chidamide, administered concomitantly with fixed-dose sintilimab in 21-days cycles up to 12 months. No dose-limiting events were observed, RP2D of chidamide was 30 mg twice a week. Twenty-nine patients were enrolled in phase 2. In the intention-to-treat population (n = 37), overall response rate was 59.5% with a complete remission rate of 48.6%. The median DOR, progression-free survival (PFS), and overall survival (OS) were 25.3, 23.2, and 32.9 months, respectively. The most common grade 3 or higher treatment-emergent adverse events (AEs) were neutropenia (28.9%) and thrombocytopenia (10.5%), immune-related AEs were reported in 18 (47.3%) patients. Exploratory biomarker assessment suggested that a combination of dynamic plasma ctDNA and EBV-DNA played a vital prognostic role. STAT3 mutation shows an unfavorable prognosis. Although outcome of anticipate ORR was not achieved, sintilimab plus chidamide was shown to have a manageable safety profile and yielded encouraging CR rate and DOR in RR-ENKTL for the first time. It is a promising therapeutic option for this population.

Indexed as

AminopyridinesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesHistone Deacetylase InhibitorsLymphoma, Extranodal NK-T-CellAdultAgedFemaleHumansMaleMiddle AgedProgrammed Cell Death 1 ReceptorAminopyridinesAntibodies, Monoclonal, HumanizedBenzamidesHistone Deacetylase InhibitorsN-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamidePDCD1 protein, humanProgrammed Cell Death 1 Receptorsintilimab

Identifiers

PMID38755119
PMCPMC11099117

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Registered trials

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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.