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Head and Neck Squamous Cell CarcinomaPhase 2NCT05343325

The Efficacy and Safety of Neoadjuvant Low-dose Radiotherapy Combined With Chemoimmunotherapy in Locally Advanced HNSCC

A Phase 2 study testing Tislelizumab and Low-dose radiotherapy in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Treatment, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Tislelizumab and Low-dose radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesChina
Study dates
9 Mar 2022to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system;
  • Eligible for radical surgery, as judged by surgeons.
  • Aged ≥ 18 years and ≤ 70 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Life expectancy of more than 6 months.
  • At least one measurable lesion according to RECIST 1.1.
Show all 34Show fewer
  • Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test):
  • Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 109/L; and platelet count ≥ 100 × 109/L;
  • Serum albumin ≥ 28 g/L;
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN;
  • Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min;
  • Activated partial clotting enzyme time and international standardized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ).
  • 43/5000
  • Thyroid Stimulating Hormone (TSH) ≤ULN; If abnormal, T3 and T4 levels should be examined, and patients with normal T3 and T4 levels can be screened.
  • Women of childbearing age should agree to the use of contraception (e.g., intrauterine devices, birth control pills, or condoms) during drug administration and for 3 months thereafter.
  • Subjects voluntarily join the study and sign an informed consent form, with good compliance.
  • Exclusion Criteria (Patients will be excluded if any of the following criteria is met):
  • Pregnant or lactating women.
  • A history of allergies to PD-1 inhibitors or any of albumin-bound paclitaxel or cisplatin.
  • A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
  • Uncontrolled cardiac clinical symptoms or diseases, such as :(1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) patients with clinically significant ventricular or ventricular arrhythmias requiring intervention.
  • Have received any of the following treatments:
  • Any research drug received prior to the first dose of the current research drug.
  • Joined another clinical study at the same time, unless it is an observational (noninterventional) clinical study or an intervention during a follow-up.
  • Needed systemic treatment with corticosteroids (more than 10 mg of prednisone or equivalent per day) or other immunosuppressants within 2 weeks prior to the first dose of the study drug, except for the use of corticosteroids for local inflammation and prevention of allergies or nausea and vomiting. In the absence of active autoimmune diseases, inhalation or partial use of steroids and adrenal corticosteroid replacements at doses greater than 10 mg per day of fentanyl equivalent is permitted.
  • Live vaccines were administered within 4 weeks prior to the first administration of research drugs.
  • Major surgery or severe trauma within four weeks of initial use of the study drug.
  • Serious infections (greater than grade 2 according to the Common Terminology Criteria for Adverse Events), such as severe pneumonia, bacteremia, and infection comorbidities, which required hospitalization, occurred within 4 weeks prior to the first dose of the study drug; baseline chest imaging examinations indicate the presence of active lung inflammation or symptoms and signs of infection within 2 weeks prior to the first dose of the study drug or indicate the need for oral or intravenous antibiotic treatment (excluding the use of preventive antibiotics).
  • A history of active autoimmune diseases and syndromes (including, but not limited to, interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo or cured childhood asthma/allergies that do not require any intervention in adulthood are not excluded.
  • A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation.
  • Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment.
  • Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection).
  • Known history of psychotropic drug abuse, alcoholism and drug use.
  • Not suitable for inclusion, as judged by the researcher.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Zhigang Liu

    Dongguan, 523059

  • Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

Other trials in China

About this study

Official title: Neoadjuvant Low-dose Radiotherapy, Tislelizumab, Combined With Albumin-bound Paclitaxel and Cisplatin in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (NeoRTPC02): an Open Label, Single-arm, Phase II Clinical Trial

This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. The eligible patients are scheduled to administered neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin for two cycles. Radical resection will be performed in 3-4 weeks after two cycles of neoadjuvant therapy. The overall primary study hypothesis is that the novel neoadjuvant combination regime improves the pathological complete response (pCR) rate, with tolerable side effects.

Being tested
Tislelizumab, Low-dose radiotherapy
Keywords
locally advanced HNSCC, neoadjuvant treatment, low-dose radiotherapy, pathological response rates
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • TislelizumabDrug

    Also called Albumin-bound paclitaxel, Cisplatin

    Tislelizumab: 200 mg D1, Q3W for two cycles. Albumin-bound paclitaxel: 100mg/m2, D1, D8, D15, Q3W for two cycles. Cisplatin: 25mg/m2, D1, D8, D15, Q3W for two cycles.

  • Low-dose radiotherapyRadiation

    Low-dose radiotherapy: 1GY/1F, D1, D2, D8, D15, Q3W for two cycles. The total radiation dose will be GTV 8Gy/8F, GTVnd 8 Gy/8F.

Study groups in NCT05343325
Study groupRoleWhat they receive
Low-dose Radiotherapy, Tislelizumab, Combined With Albumin-bound Paclitaxel and CisplatinExperimentalNeoadjuvant therapy will be performed for a total of 2 cycles, with 21 days as a cycle, which includes: ① Low-dose radiotherapy: 1GY/1F, D1, D2, D8, D15, Q3W for two cycles, and the total dose of radiation in the two cycles will be GTV 8 Gy/8 F and GTVnd 8 Gy/8 F; ② Teilizumab: 200 mg D1, Q3W for two cycles; ③ Albumin-bound paclitaxel: 100mg/m2, D1, D8, D15, Q3W for two cycles; ④Cisplatin: 25mg/m2, D1, D8, D15, Q3W for two cycles.
Receives: Drug: Tislelizumab; Radiation: Low-dose radiotherapy

What is being measured

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

  1. Pathological complete response (pCR) rate

    the proportion of patients with no residual viable tumor cell under microscope

    Measured: 1 week after surgery

Secondary outcomes (6)

  1. Major pathological response (MPR) rate

    the proportion of patients with the percentage of residual viable tumor cells in the tumor bed less than 10%

    Measured: 1 week after surgery

  2. Objective Response Rate (ORR)

    the proportion of patients with radiographic objective responses (complete response and partial response)

    Measured: 3-4 weeks after two cycles of neoadjuvant therapy

  3. Incidence of treatment-related adverse events

    CTCAE 5.0

    Measured: from the first day of treatment to 30 days after surgery

  4. Non-surgery-delay rate

    the proportion of patients with surgical operation conducted more than four weeks longer than scheduled

    Measured: 8 weeks after two cycles of neoadjuvant therapy

  5. EORTC QLQ-C30

    Quality of life evaluation

    Measured: from 1 week before treatment to 30 days after surgery

  6. EORTC HN35

    Quality of life evaluation

    Measured: from 1 week before treatment to 30 days after surgery

Timeline

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

  1. First posted25 Apr 2022
  2. Study start9 Mar 2022
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2027 (estimated)

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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05343325
Sponsor's protocol ID
ZDWY.ZLZX.011
Status last verified
Sep 2026
First submitted
13 Apr 2022
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab and Low-dose radiotherapy in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Treatment, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 2 sites 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 34 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Pathological complete response (pCR) rate (time frame: 1 week after 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 NCT05343325.

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 9 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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