Evidence map›Paper›PMID 35747712›Full record

ArticleCancer management and research2022

Efficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial.

Jia Wei, Xiaofeng Lu, Qin Liu, Yao Fu, Song Liu, Lin Li, Fangcen Liu, Xiangshan Fan, Ju Yang, Yang Yang and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancer management and research, 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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

9 citing papers in PubMed, 13 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.

Jia WeiThe Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, 210008, People's Republic of China.
Xiaofeng LuDepartment of General Surgery, Drum Tower Hospital, Nanjing, 210008, People's Republic of China.
Qin LiuThe Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, 210008, People's Republic of China.
Yao FuDepartment of Pathology, Drum Tower Hospital, Nanjing, 210008, People's Republic of China.
Song LiuDepartment of Radiology, Drum Tower Hospital, Nanjing, 210008, People's Republic of China.
Lin LiDepartment of Pathology, Drum Tower Hospital, Nanjing, 210008, People's Republic of China.
Fangcen LiuDepartment of Pathology, Drum Tower Hospital, Nanjing, 210008, People's Republic of China.
Xiangshan FanDepartment of Pathology, Drum Tower Hospital, Nanjing, 210008, People's Republic of China.
Ju YangThe Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, 210008, People's Republic of China.
Yang YangThe Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, 210008, People's Republic of China.
Yang ZhaoDepartment of Biostatistics, Nanjing Medical University, Nanjing, 210029, People's Republic of China.
Wenxian GuanDepartment of General Surgery, Drum Tower Hospital, Nanjing, 210008, People's Republic of China.
Baorui LiuThe Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, 210008, People's Republic of China.
Nanjing Drum Tower Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Concurrent chemoradiotherapy (cCRT) is the mainstay therapy of locally advanced gastric (G) and gastroesophageal junction (GEJ) cancers with a poor prognosis. Programmed cell death receptor-1 (PD-1) inhibitor has been approved and recommended to treat ≥3 line G/GEJ patients. A significant clinical benefit of PD-1 inhibitors in addition to cCRT has been observed in locally advanced lung cancer. Sintilimab, a humanized IgG4 monoclonal antibody with high affinity and specificity for PD-1, has shown promising efficacy with an overall response rate of 85% in combination with chemotherapy in gastric cancer in a phase Ib study (NCT02937116). Patients and Methods: SHARED is a prospective, multicentre, single-arm Phase II trial in China, exploring the efficacy of sintilimab in combination with cCRT in locally advanced G/GEJ adenocarcinoma. According to a Simon optimal two-stage clinical design, 34 patients will be enrolled. All the eligible patients will receive one cycle of induction chemotherapy (S-1 plus nab-PTX) combined with sintilimab, followed by cCRT (radiotherapy plus nab-PTX) combined with sintilimab. Prior to the surgery, patients will receive another cycle of chemotherapy (S-1 plus nab-PTX) combined with sintilimab. In the adjuvant setting, all participants will be treated with 3 cycles of chemotherapy (S-1 plus nab-PTX) combined with sintilimab. The primary endpoint is the rate of pathological complete response (pCR). The secondary endpoints include disease-free survival (DFS), major pathological response (MPR), R0 resection rate, surgical AEs, overall survival (OS), event-free survival (EFS), and safety profile. Moreover, the prognostic value of tumor biomarkers and immune biomarkers will be explored. Conclusion: SHARED is designed to primally evaluate the efficacy and safety of sintilimab in combination with cCRT in locally advanced G/GEJ cancers and to prospectively validate the prognostic value of tumor biomarkers and immune biomarkers.

Indexed as

anti-PD-1chemoradiotherapyimmunotherapyinduction chemotherapy

Identifiers

PMID35747712
PMCPMC9211075
OpenAlexW4282975934

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.