Evidence map›Paper›PMID 35647908›Full record

ArticleThe oncologist2022

Sintilimab in Patients with Previously Treated Metastatic Neuroendocrine Neoplasms.

Ru Jia, Yi Li, Nong Xu, Hai-Ping Jiang, Chuan-Hua Zhao, Rong-Rui Liu, Yue Shi, Yao-Yue Zhang, Shu-Yan Wang, Hui Zhou and 1 more

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

Article in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02937116 (An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.5field-weighted citation impact, top 11% 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.

NCT02937116 phase1completednot on this map

An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors

TypeinterventionalSponsorInnovent Biologics (Suzhou) Co. Ltd.Ran2016 to 2020Enrolled233ConditionsCancer, Solid TumorArmsIBI308, IBI308\Cisplatinum\Pemetrexed, IBI308\cisplatin\gemcitabine, IBI308\oxaliplatin\capecitabine, IBI308\etoposide\cisplatin
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 17 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

11 authors at 2 institutions in 1 country.

Ru JiaSenior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, People's Republic of China.
Yi LiSenior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, People's Republic of China.
Nong XuDepartment of Oncology, The First Affiliated Hospital of the Medical School of Zhejiang University, Hangzhou, People's Republic of China.
Hai-Ping JiangDepartment of Oncology, The First Affiliated Hospital of the Medical School of Zhejiang University, Hangzhou, People's Republic of China.
Chuan-Hua ZhaoSenior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, People's Republic of China.
Rong-Rui LiuSenior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, People's Republic of China.
Yue ShiSenior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, People's Republic of China.
Yao-Yue ZhangSenior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, People's Republic of China.
Shu-Yan WangMedical Science and Strategy Oncology, Innovent Biologics, Inc., Suzhou, People's Republic of China.
Hui ZhouMedical Science and Strategy Oncology, Innovent Biologics, Inc., Suzhou, People's Republic of China.
Jian-Ming XuSenior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, People's Republic of China.ORCID 0000-0003-4467-6021
Chinese PLA General Hospital · CNZhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeuroendocrine neoplasms (NENs) are a group of diseases that show high heterogeneity but have limited treatment options. This phase I study evaluated the safety and efficacy of sintilimab, anti-PD-1 monoclonal antibody, in treating advanced NENs.

methodsWe prospectively enrolled patients pathologically diagnosed with NENs after standard treatment failure. Neuroendocrine neoplasms were classified into well-differentiated neuroendocrine tumors (NETs) and poorly differentiated neuroendocrine cancers (NECs). Every patient received sintilimab, and response was assessed every 9 weeks.

resultsTwenty-four patients with a median age of 57.0 years were enrolled from November 2016 to 2017. The median Ki-67 index was 60%. Five patients had NET, 1 had NET G3, 17 had NEC, and 1 had mixed adenocarcinoma-neuroendocrine carcinoma. The most common primary tumor sites were the pancreas and gastrointestinal tract in 7 and 10 patients, respectively. In phase Ia trial, 2 patients received sintilimab 1 mg/kg every 2 weeks, one received 3 mg/kg every 2 weeks, and 21 patients enrolled in the phase Ib trial received 200 mg every 3 weeks. The objective response rate was 20.8% in all enrolled patients and 27.8% in NEC patients. The median progression-free survival was 2.2 and 2.1 months in patients with NET and NEC, respectively. The median OS was not applicable (NA) and 10.8 months (95% CI, 4.3, NA) with NET and NEC, respectively. The duration of response (DOR) was not reached, with a median follow-up time of 20.7 months. Treatment-related adverse events (TRAE) occurred in 17 (70.8%) patients. The most frequent TRAE was thyroid dysfunction (41.7%), and a grade 3 pulmonary infection occurred in 1 patient. The programmed cell death 1-ligand 1 (PD-L1)-positive (tumor proportion score ≥1%) rate was 18.8% (3 out of 16) and the expression of PD-L1 did not correlate with response.

conclusionSintilimab was well-tolerated and showed encouraging response in NECs. CLINICALTRIALS.GOV IDENTIFIER: NCT02937116.

Indexed as

Carcinoma, NeuroendocrineNeuroendocrine TumorsAntibodies, Monoclonal, HumanizedB7-H1 AntigenHumansMiddle AgedAntibodies, Monoclonal, HumanizedB7-H1 Antigensintilimabanti-PD-1 antibodycheckpoint blockadeimmunotherapyneuroendocrine cancersneuroendocrine neoplasms

Identifiers

PMID35647908
PMCPMC9355821
OpenAlexW4226115483

What OpenQuestion holds

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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.