Evidence map›Paper›PMID 42731876›Full record

Trial reportJournal for immunotherapy of cancer2026

Neoadjuvant chemoimmunotherapy with afatinib for locally advanced head and neck squamous cell carcinoma (neoCHANCE-2): an open-label, single-arm, phase 2 study.

Zhigong Wei, Huijiao Chen, Dejuan Wang, Leyu Li, Yiyan Pei, Huaju Yang, Feng Wang, Jing Jin, Yiqiao Luo, Fei Chen and 2 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05516589 (Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma), which is not on this map. Cited by 1 paper.

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

NCT05516589 phase2completednot on this map

Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial (neoCHANCE-2 Trial)

TypeinterventionalSponsorWest China HospitalRan2022 to 2024Enrolled40ConditionsHead and Neck Squamous Cell CarcinomaArmsNab-paclitaxel, Cisplatin, Tislelizumab, Afatinib
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

12 authors.

Zhigong Wei *Department of Biotherapy, West China Hospital of Sichuan University, Chengdu, China.
Huijiao Chen *Department of Pathology, West China Hospital of Sichuan University, Chengdu, China.
Dejuan WangDepartment of Otolaryngology-Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China.
Leyu LiDepartment of Otolaryngology-Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China.
Yiyan PeiDepartment of Biotherapy, West China Hospital of Sichuan University, Chengdu, China.
Huaju YangDepartment of Biotherapy, West China Hospital of Sichuan University, Chengdu, China.
Feng WangDepartment of Otolaryngology-Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China.
Jing JinDepartment of Biotherapy, West China Hospital of Sichuan University, Chengdu, China.
Yiqiao LuoDepartment of Biotherapy, West China Hospital of Sichuan University, Chengdu, China.
Fei ChenDepartment of Otolaryngology-Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China pxx2014@163.com junliu@wchscu.edu.cn hxchenfei@163.com.
Jun LiuDepartment of Otolaryngology-Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China pxx2014@163.com junliu@wchscu.edu.cn hxchenfei@163.com.
Xingchen PengDepartment of Biotherapy, West China Hospital of Sichuan University, Chengdu, China pxx2014@163.com junliu@wchscu.edu.cn hxchenfei@163.com.ORCID http://orcid.org/0000-0001-7042-718X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile immune checkpoint inhibitor-based neoadjuvant therapy shows promise in locally advanced head and neck squamous cell carcinoma (LA-HNSCC), the optimal regimen has yet to be established. We report, for the first time, a neoadjuvant treatment that combines chemotherapy with dual blockade of the programmed cell death protein 1 and epidermal growth factor receptor pathways in LA-HNSCC.

methodsIn this single-arm phase 2 trial (NCT05516589) conducted at a single academic center, patients with LA-HNSCC were enrolled and received two cycles of tislelizumab and TP chemotherapy (nab-paclitaxel and cisplatin), administered on day 1 of each 3-week cycle, along with afatinib during the interval between chemoimmunotherapy cycles, followed by surgical resection. The primary endpoint was the complete pathologic response (pCR) rate. Secondary endpoints included the major pathologic response (MPR) rate, objective response rate (ORR), event-free survival, overall survival (OS), and safety.

resultsA total of 40 patients were enrolled and received neoadjuvant treatment, 32 of whom proceeded to surgical resection; among these patients, the pCR rate was 40.6% (95% CI 23.7% to 59.4%). The ORR was 82.5% (95% CI 67.2% to 92.7%). The 1-year OS rate was 97.3% (95% CI 92.2% to 100%). The most common treatment-related adverse event (TRAE) of grade 3-4 was lymphopenia (5/40, 12.5%). No grade 5 TRAEs leading to death occurred, and no treatment-related surgical delays were observed. In the prespecified exploratory biomarker analysis, increased cytotoxic T lymphocytes and B cells in the tumor immune microenvironment may be associated with pCR/MPR. Neoadjuvant treatment induced a significant increase in the proportion of peripheral CD8+T cells, along with a reduction in B cells.

conclusionsWe report, for the first time, the promising efficacy and acceptable safety profile of neoadjuvant chemoimmunotherapy combined with afatinib in patients with LA-HNSCC. Neoadjuvant treatment potentially induced an immune-enhanced tumor microenvironment. Further evaluation in large-scale clinical trials with longer follow-up periods is needed. TRIAL REGISTRATION NUMBER: NCT05516589.

Indexed as

AfatinibAntineoplastic Combined Chemotherapy ProtocolsHead and Neck NeoplasmsImmunotherapyNeoadjuvant TherapySquamous Cell Carcinoma of Head and NeckAdultAgedFemaleHumansMaleMiddle AgedPathologic Complete ResponseAfatinibChemotherapyEGFRHead and Neck CancerImmune Checkpoint InhibitorsNeoadjuvant

Identifiers

PMID42731876
PMCPMC13583779

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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.