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Head and Neck Squamous Cell CarcinomaPhase 2NCCCNRHNSCCNCT06023875

Neoadjuvant Cadonilimab in Combination With Cisplatin and Nab-paclitaxel in Resectable Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Cadonilimab, Docetaxel and Cisplatin in people with Head and Neck Squamous Cell Carcinoma and Locally Advanced Operable, run by Xuekui Liu at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a single arm phase ll trial including 30 patients with T2N2-3M0、T3-4N0-3M0 (lll-V) head and neck squamous cell carcinoma (HNSCC) eligible forresection, who receive neo-adjvuant Cadonilimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Cadonilimab, Docetaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
19 Jul 2023to 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed primary head and neck squamous cell carcinoma confirmed by histology and/or cytology (excluding diagnostic therapy).
  • Clinical stage: T2N2-3M0, T3-4N0-3M0 (III-IV) (AJCC 8th edition staging).
  • Age: 18 to 70 years.
  • PS score (see Appendix Table 1; performance status score of 0 or 1).
  • Patients evaluated by a head and neck oncologist as resectable with no distant metastases.
  • Patients with at least one measurable lesion according to RECIST version 1.1 criteria.
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  • Patients' toxicities assessed according to CTCAE version 4.03 criteria.
  • Patients with normal organ function (heart, brain, lungs, kidneys) and suitable for surgery:
  • Hematology: White blood cells ≥ 4000/μL, neutrophils ≥ 2,000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL;
  • Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin levels ≤ 3 times ULN can be included), AST and ALT ≤ 3 times ULN, alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3 g/dL;
  • Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min according to Cockcroft-Gault formula.
  • Consent to provide archived tumor tissue samples or undergo biopsy for collection of tumor lesion tissue (at least 3 unstained FFPE pathological slides, if deemed insufficient for PD-L1 IHC testing by the central laboratory, an additional 3 unstained FFPE pathological slides should be provided) to be sent to the central laboratory for PD-L1 immunohistochemistry (IHC) testing (preferably using recently obtained tumor tissue samples). Tumor lesions planned for biopsy should not be used for assessing target lesions of the disease unless no other suitable lesions for biopsy are available. Patients have signed an informed consent form, are willing and able to comply with the study's visit, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • History of severe hypersensitivity reactions to components of other monoclonal antibodies, CTLA4, or PD-1 antibodies.
  • Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
  • Recurrence, distant metastasis, or the inability to undergo surgery as assessed by a head and neck physician.
  • Abnormal coagulation function: (PT > 16s, APTT > 53s, TT > 21s, Fib < 1.5g/L), bleeding tendency, or currently on anticoagulant or thrombolytic therapy.
  • Severe heart disease, pulmonary dysfunction, patients with heart or lung function below Grade 3 (including Grade 3).
  • Laboratory values not meeting relevant criteria within 7 days prior to enrollment.
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  • Previous use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co-stimulation or checkpoint pathways).
  • Pre-existing conditions requiring long-term use of immunosuppressive drugs or a need for systemic or local use of corticosteroids at immunosuppressive doses prior to enrollment.
  • HIV-positive individuals; HBsAg-positive individuals with positive HBV DNA copy number (quantitative test ≥ 1000 cps/ml); positive chronic hepatitis C blood screening (HCV antibody positive).
  • Traditional herbal medicine used for anti-tumor purposes within 4 weeks before randomization.
  • Active or prior history of documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).
  • Women of childbearing potential with a positive pregnancy test and breastfeeding women.
  • Known active pulmonary tuberculosis (TB). Subjects suspected of having active TB need clinical evaluation for exclusion.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Severe infection occurring within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
  • Subjects planning major surgery within 30 days after the first dose of AK104 in combination with platinum-containing dual-agent therapy (as determined by the investigator), or not yet fully recovered from prior surgery. Local surgical procedures (such as placement of a systemic port and prostate biopsy) are allowed provided that the surgery is completed at least 24 hours before the first dose of the study treatment.

Trial locations and contacts

2 sites in 1 country.

Xuekui Liu contact

+8613609713406

liuxk@sysucc.org.cn

China2 sites, 2 recruiting

  • Sun Yat-sen University Cancer Center, 651 Dongfeng East Road

    Guangzhou, Guangdong, 510060

    Xiaoyun Feng, +8615900033919, 1056608539@qq.com

    Recruiting

  • Sun Yat-sen University Cancer Center, 651 Dongfeng East Road

    Guangzhou

    Recruiting

Other trials in China

About this study

Official title: An Open, Single-center, Phase II Trial of Cadonilimab Combined With Platinum-containing Dual-agent Neoadjuvant Therapy for Locally Advanced Operable Head and Neck Squamous Cell Carcinoma

This study is a single arm phase ll trial including 30 patients with T2N2-3M0、T3-4N0-3M0 (lll-V) head and neck squamous cell carcinoma (HNSCC) eligible forresection, who receive neo-adjvuant Cadonilimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of preoperativeadministration of Cadonilimab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.

Read the detailed description

In this study, eligible subject will be enrolled into study arm to accept study treatment objective response rate will be the primary outcome measures.

Being tested
Cadonilimab, Docetaxel, Cisplatin
Keywords
head and neck squamous cell carcinoma, Cadonilimab, neoadjuvant therapy
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.

  • CadonilimabDrug

    Also called AK104

    Cadonilimab 10mg/kg. The drug was administered every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.

  • DocetaxelDrug

    Docetaxel 75mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.

  • CisplatinDrug

    Cisplatin 60mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.

Study groups in NCT06023875
Study groupRoleWhat they receive
Experimental groupExperimentalPatients with locally advanced operable head and neck squamous cell carcinoma
Receives: Drug: Cadonilimab; Drug: Docetaxel; Drug: Cisplatin

What is being measured

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

  1. ORR

    overall response rate

    Measured: 9 weeks

Secondary outcomes (6)

  1. PCR

    Pathological Complete Response

    Measured: 9 weeks

  2. MPR

    Major Pathological Response

    Measured: 9 weeks

  3. DCR

    Disease Control Rate

    Measured: 2 years

  4. PFS

    progression-free survival

    Measured: 2 years

  5. OS

    Overall survival

    Measured: 5 years

  6. Adverse Events Graded By Ctcae V5.0

    Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

    Measured: 90 days after the first dose of study treatment

Timeline

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

  1. First posted5 Sep 2023
  2. Study start19 Jul 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06023875
Sponsor's protocol ID
2023-FXY-011-HNC
Acronym
NCCCNRHNSCC
Status last verified
Aug 2023
First submitted
29 Aug 2023
Last updated
5 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cao F, Li Y, Fang Q, Lin R, Zhao Z, Xu P, Yan H, Zhang X, Jiang K, Zhou J, Chen C, Lu L, Han F, Li Z, Wu D, Liu X. Cadonilimab (a PD-1/CTLA-4 Bispecific Antibody) plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial. Clin Cancer Res. 2025 Sep 15;31(18):3876-3885. doi: 10.1158/1078-0432.CCR-25-1445.

    PubMed 40705040

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab, Docetaxel and Cisplatin in people with Head and Neck Squamous Cell Carcinoma and Locally Advanced Operable, run by Xuekui Liu 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 12 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. 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?

Results are not available in the source record.

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

Contact Xuekui Liu (+8613609713406, liuxk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 9 weeks). 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 NCT06023875, 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 5 Sep 2023.

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