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Head and Neck Squamous Cell CarcinomaPhase 2neoCHANCE-2NCT05516589

Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for HNSCC

A Phase 2 study testing Nab-paclitaxel, Cisplatin and Tislelizumab in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To explore the efficiency and safety of TP chemotherapy, tislelizumab, combined with afatinib as a new neoadjuvant treatment regimen for patients with resectable HNSCC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Nab-paclitaxel, Cisplatin and Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
12 Sep 2022to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or above.
  • Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following conditions:
  • were newly diagnosed and without distant metastasis;
  • were deemed surgically resectable evaluated by a head and neck surgeon;
  • were willing to undergo surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
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  • Adequate organ and bone marrow function:
  • absolute neutrophil count ≥ 1.5 × 10^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10^9/L;
  • ALT, AST and ALP < 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN;
  • albumin≥ 2.8 g/dL；
  • creatinine clearance ≥ 60 ml/min；
  • INR≤ 1.5；APTT≤ 1.5×ULN；
  • Written informed consent.

Who cannot join

  • History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
  • Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
  • Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
  • Any of prior therapy with:
  • anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs；
  • antitumor vaccine;
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  • any active vaccine against an infectious disease within 4 weeks prior to the first dose or planned during the study period;
  • major surgery or serious trauma within 4 weeks before the first dose;
  • toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 Grade 1 or the level specified by the inclusion/exclusion criteria.
  • With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction < 50%, etc.
  • With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
  • With hyperthyroidism, or organic thyroid disease.
  • With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
  • With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
  • History of a clear neurological or psychiatric disorder.
  • History of drug abuse or alcohol abuse.
  • Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures.
  • Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
  • Any other factors that are not suitable for inclusion in this study judged by investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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)

To explore the efficiency and safety of TP chemotherapy, tislelizumab, combined with afatinib as a new neoadjuvant treatment regimen for patients with resectable HNSCC.

Read the detailed description

More than 60% of patients with Head and neck squamous cell carcinoma (HNSCC) have locally advanced or metastatic disease at the time of diagnosis, with a 5-year overall survival rate of less than 60%. The clinical outcomes of those patients still need to be improved.

Neoadjuvant therapy theoretically could reduce tumor volume, increase organ retention rate, and improve clinical prognosis. However, results from several phase III clinical trials have not proved a significant survival benefit of neoadjuvant chemotherapy for patients with resectable HNSCC except for nasopharyngeal carcinoma. There is an urgent need to explore new neoadjuvant treatment options for those patients.

Immunotherapy such as PD-1/PD-L1 inhibitors have shown excellent efficiency in the treatment of malignancies. Anti-PD-1 therapy is approved as the first-line treatment of recurrent/metastatic HNSCC. Neoadjuvant immunotherapy for the treatment of locally advanced and resectable HNSCC has been demonstrated to be feasible in some trials.

Afatinib, as an irreversible ErbB tyrosine kinase inhibitor (TKI), has been used as the second-line treatment for recurrent and/or metastatic HNSCC. A previous study published in 2018 confirmed that afatinib can be administered safely before surgery.

In summary, we designed this study to explore the efficiency and safety of chemotherapy (TP regimen), anti-PD1 immunotherapy (tislelizumab), combined with EGFR-TKI (afatinib) as a new neoadjuvant treatment regimen for patients with resectable HNSCC, aiming to provide a new treatment option for those patients.

Being tested
Nab-paclitaxel, Cisplatin, Tislelizumab, Afatinib
Keywords
Head and Neck Cancer, Neoadjuvant therapy, Immunotherapy, EGFR-TKI, Chemotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nab-paclitaxelDrug

    Also called Albumin-bound paclitaxel, Abraxane

    260mg/m^2 IV Q3W

  • CisplatinDrug

    Also called CDDP

    75mg/m^2 IV Q3W

  • TislelizumabBiological

    Also called BGB-A317

    200mg IV Q3W

  • AfatinibDrug

    30mg PO QD

Study groups in NCT05516589
Study groupRoleWhat they receive
Treatment CohortExperimentalParticipants will receive * TP chemotherapy every 3 weeks x 2 cycles (Nab-paclitaxel 260mg/m^2 IV on day1, Cisplatin 75mg/m^2 IV on day 1); * Tislelizumab 200mg IV every 3 weeks x 2 cycles; * Afatinib 30mg PO everyday x 6 weeks.
Receives: Drug: Nab-paclitaxel; Drug: Cisplatin; Biological: Tislelizumab; Drug: Afatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response

    Pathologic complete response was defined as the absence of viable tumor cells.

    Measured: Time of surgery

Secondary outcomes (5)

  1. Major Pathologic Response

    Major pathologic response was defined as fewer than 10% viable tumor cells.

    Measured: Time of surgery

  2. Objective Response Rate

    Objective response rate was defined as the percentage of participants with a best overall response of CR or PR using RECIST Criteria

    Measured: Up to 8 weeks

  3. Adverse Events

    Adverse events included adverse events using CTCAE Criteria and unplanned surgery delays.

    Measured: Up to 12 weeks

  4. Disease-free Survival

    Disease-free survival was defined as the time from the administration of the first dose to first disease progression or death.

    Measured: 1 year

  5. Overall Survival

    Overall survival was defined as the time from the administration of the first dose to death.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2022
  2. Study start12 Sep 2022
  3. Primary completion29 Oct 2023
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05516589
Sponsor's protocol ID
ChiECRCT20210621
Acronym
neoCHANCE-2
Status last verified
May 2025
First submitted
19 Aug 2022
Last updated
22 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wei Z, Chen H, Wang D, Li L, Pei Y, Yang H, Wang F, Jin J, Luo Y, Chen F, Liu J, Peng X. Neoadjuvant chemoimmunotherapy with afatinib for locally advanced head and neck squamous cell carcinoma (neoCHANCE-2): an open-label, single-arm, phase 2 study. J Immunother Cancer. 2026 Sep 12;14(9):e014100. doi: 10.1136/jitc-2025-014100.

    PubMed 42731876

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel, Cisplatin and Tislelizumab in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (time frame: Time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05516589, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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