Evidence map›Paper›PMID 36224603›Full record

ArticleJournal of experimental & clinical cancer research : CR2022

Neoadjuvant toripalimab combined with gemcitabine and cisplatin in resectable locally advanced head and neck squamous cell carcinoma (NeoTGP01): An open label, single-arm, phase Ib clinical trial.

Xiaotao Huang, Qiaodan Liu, Guihua Zhong, Yingpeng Peng, Ye Liu, Lizhong Liang, Haiyu Hong, Weineng Feng, Shuang Yang, Yaqin Zhang and 7 more

Open access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of experimental & clinical cancer research : CR, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 5 pooled it
12.3field-weighted citation impact, top 1% 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.

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

44 citing papers in PubMed, 5 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Progress in immunotherapy for resectable head and neck squamous cell carcinoma.Medical oncology (Northwood, London, England) · 2025
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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

17 authors at 4 institutions in 2 countries.

Xiaotao Huang *The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, 519000, Guangdong, China.
Qiaodan Liu *The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, 519000, Guangdong, China.
Guihua Zhong *The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, 519000, Guangdong, China.
Yingpeng Peng *The Cancer Center of the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, 519000, Guangdong, China.
Ye Liu *Department of Pathology, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China.
Lizhong LiangDepartment of Oral and Maxillofacial Surgery, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China.
Haiyu HongDepartment of Otolaryngology, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China.
Weineng FengHead and Neck/Thoracic Medical Oncology, Foshan First People's Hospital, Foshan, Guangdong, China.
Shuang YangHead and Neck/Thoracic Medical Oncology, Foshan First People's Hospital, Foshan, Guangdong, China.
Yaqin ZhangDepartment of Radiology, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China.
Shiping XianDepartment of Pathology, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China.
Zhanyu LiDepartment of Pathology, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China.
Yuling ZhouThe Cancer Center of the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, 519000, Guangdong, China.
Zhaoyuan ZhangThe Cancer Center of the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, 519000, Guangdong, China.
Wen JiangDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jun LiangDepartment of Oral and Maxillofacial Surgery, Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China. liangjun@mail.sysu.edu.cn.
Zhi-Gang LiuThe Cancer Center of the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, 519000, Guangdong, China. zhigangliu1983@hotmail.com.
Sun Yat-sen University · CNFifth Affiliated Hospital of Sun Yat-sen University · CNFirst People's Hospital of Foshan · CNThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeoadjuvant programmed death receptor-1 (PD-1) inhibitors have drawn increasing attention in locally advanced head and neck squamous cell carcinoma (HNSCC). In this study, we investigated the safety and efficacy of gemcitabine and cisplatin (GP), combined with a PD-1 inhibitor, in patients with locally advanced HNSCC. MATERIALS AND

methodsA total of 23 eligible patients were administered two cycles of toripalimab and GP followed by surgical resection. The primary endpoints were safety, treatment-related adverse events (TRAEs), and non-operation delay rates. The secondary endpoints consisted of pathological complete response (pCR) rate, major pathological response (MPR) rate, objective response rate (ORR), and R0 resection rate.

resultsThe incidence of TRAEs from grades 1 to 4 was 43.5%, 34.8%, 13.0%, and 8.7%, respectively. Grade 3/4 TRAEs included neutropenia, fatigue, hyperglycemia, nausea and vomiting, decreased appetite, rash, and diarrhea. No treatment-related surgical delay was observed. The radiographic response rates were 5.0% (CR), 40.0% (PR), and 55.0% (SD). The ORR reached 45.0%. Eighteen patients underwent successful surgical resection. The R0 resection rate was 100%. The pathological response rates were 16.7% (pCR), 27.8% (MPR, two of five near-pCR), 16.7% (PPR), and 38.8% (NPR). CD4, CD8, CD20, and CD38 expression in the tumors significantly increased after neoadjuvant chemotherapy. The increase in CD20 levels after neoadjuvant treatment in patients with pCR/MPR was significantly higher than in patients with PPR/NPR.

conclusionTriweekly neoadjuvant toripalimab-GP is feasible and achieves promising pCR and MPR rates in patients with resectable locally advanced HNSCC.

trial registrationChinese clinical trial registry, ChiCTR2100043743, Registered 27 Febrary 2021- Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=120570.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckAntibodies, Monoclonal, HumanizedCisplatinDeoxycytidineGemcitabineHumansImmune Checkpoint InhibitorsNeoadjuvant TherapyProgrammed Cell Death 1 ReceptorReceptors, Death DomainAntibodies, Monoclonal, HumanizedCisplatinDeoxycytidineGemcitabineImmune Checkpoint InhibitorsProgrammed Cell Death 1 ReceptorReceptors, Death DomaintoripalimabHead and neck squamous cell carcinomaImmunotherapyNeoadjuvant treatmentPathological response rate

Identifiers

PMID36224603
PMCPMC9558942
OpenAlexW4304694229

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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.