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Head and Neck Squamous Cell CarcinomaPhase 2NCT06725498

Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC

A Phase 2 study testing Tislelizumab-jsgr, Cisplatin and Albumin-Bound Paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Beijing Tongren Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study pioneers a novel approach by integrating a new auxiliary chemo-immunotherapy regimen, which is then followed by an evaluation of the potential for surgical resection. For those patients who remain non-resectable, a tailored treatment plan is proposed, consisting of arterial infusion chemotherapy in… 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?
Tislelizumab-jsgr, Cisplatin and Albumin-Bound Paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Dec 2024to 30 Nov 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with T4bNanyM0 Head and neck squamous cell carcinoma (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer or oral cavity) with a confirmed diagnosis by histology and/or cytology;
  • Expected survival ≥3 months, with adequate organ function;
  • Investigators believe they can safely receive treatment with PD-1 combined with platinum and albumin-bound paclitaxel;
  • Age ≥18 years;
  • ECOG score of 0-1;
  • Measurable disease as defined by RECIST v1.1;
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  • Adequate bone marrow reserve and organ function: Absolute neutrophil count (ANC) ≥1,000/microliter (mcL), platelets ≥75,000/mcL, hemoglobin ≥8g/dL, without transfusion or dependence on erythropoietin (EPO) (within 7 days after assessment);
  • Renal function: Serum creatinine ≤1.5 times the upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥60mL/min with creatinine levels > 1.5 times the institutional ULN. (GFR can also be used in place of creatinine or CrCl). Creatinine clearance should be calculated according to institutional standards;
  • Liver function: For subjects with a total bilirubin level >1.5 ULN, serum total bilirubin ≤1.5 times ULN or direct bilirubin ≤ULN; For patients with liver metastases, aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 times ULN OR ≤5 times ULN; Albumin > 2.5 mg/dL;
  • Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, if the subject is receiving anticoagulant therapy, PT or PTT should be within the permissible range of the anticoagulant used;
  • Females should agree to use contraceptive measures (such as intrauterine device (IUD), oral contraceptives, or condoms) during the study and for 6 months after the study ends; Negative serum or urine pregnancy test within 7 days before study entry, and must be non-lactating patients; Males should agree to use contraceptive measures during the study and for 6 months after the study ends.

Who cannot join

  • Patients with a history of prior immunotherapy, radiotherapy, and treatment with EGFR monoclonal antibodies;
  • Patients with a history of other (including unknown primary) malignant tumors within the past 5 years;
  • Patients who are intolerant to radiotherapy post-surgery;
  • Patients known to be allergic to the study medication or its active ingredients, excipients;
  • Patients with any unstable systemic diseases, including but not limited to: severe infections, uncontrolled diabetes, unstable angina, cerebrovascular accidents or transient ischemic attacks, myocardial infarction, congestive heart failure, serious arrhythmias requiring medication, liver, kidney, or metabolic disorders;
  • Patients with potential immune deficiencies, chronic infections, including HIV, hepatitis, tuberculosis (TB), or autoimmune diseases;
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  • Patients with potential hematological issues, including bleeding disorders, known prior gastrointestinal bleeding requiring intervention within the past 6 months, active pulmonary embolism or deep vein thrombosis (DVT) that is unstable on anticoagulation regimens;
  • A history or any evidence of active noninfectious pneumonia;
  • Known active central nervous system (CNS) metastases and/or leptomeningeal disease or carcinomatous meningitis. Subjects with previously treated brain metastases may participate if they are stable (no evidence of imaging progression for at least four weeks prior to the first trial treatment and any neurological symptoms have returned to baseline), with no new or enlarging evidence of brain metastases, and are not on steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability;
  • Concurrent use (or receipt) of medications within 7 days prior to Day 1 of Cycle 1 that may affect drug metabolism;
  • Pregnant or breastfeeding, or expecting to become pregnant or father a child during the anticipated trial period;
  • Any uncontrollable concomitant diseases, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias;
  • Prolonged corrected QT (QTc) interval > 475 ms on screening EKG;
  • Ejection fraction <40% on 2D echocardiogram (ECHO) at screening;
  • Any serious medical or psychiatric illness/condition, including substance use disorders, that may interfere with or limit adherence to study requirements/treatment in the investigator's judgment;
  • Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaohong Chen, Dr. contact

+86-10-58266699

trchxh@163.com

China1 site, 1 recruiting

  • Beijing Tongren Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 10000

    Xiaohong Chen, Dr., +86-10-58266699

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-center, Open-label Phase II Clinical Study of Intra-arterial Chemotherapy Combined with Concurrent Radiotherapy and Tislelizumab-jsgr in the Treatment of T4bNanyM0 HNSCC

This study pioneers a novel approach by integrating a new auxiliary chemo-immunotherapy regimen, which is then followed by an evaluation of the potential for surgical resection. For those patients who remain non-resectable, a tailored treatment plan is proposed, consisting of arterial infusion chemotherapy in conjunction with radiotherapy, succeeded by a series of immune checkpoint inhibitors. The efficacy and safety of this integrated therapeutic strategy are meticulously assessed, with the goal of enhancing survival outcomes for patients with T4bNanyM0 HNSCC.

Being tested
Tislelizumab-jsgr, Cisplatin, Albumin-Bound Paclitaxel, Radiotherapy
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.

  • Tislelizumab-jsgrDrug

    200mg, Q3W

  • CisplatinDrug

    60-75 mg/㎡, Q3W

  • Albumin-Bound PaclitaxelDrug

    260 mg/㎡, Q3W

  • RadiotherapyRadiation

    Radical Radiotherapy or adjuvant Radiotherapy per guidelines.

Study groups in NCT06725498
Study groupRoleWhat they receive
RT + IAC + Anti-PD-1 antibodyExperimentalPatients must undergo Multi-Disciplinary Treatment evaluation after receiving 3 cycles of neoadjuvant therapy (Tislelizumab-jsgr combined with platinum-based chemotherapy). For operable patients, Radical surgery followed by adjuvant standard (chemo)radiotherapy plus Tislelizumab-jsgr (Q3W 17 cycles). For inoperable patients, Intra-arterial Chemotherapy concurrent with Radical radiotherapy followed by Tislelizumab-jsgr (Q3W 17 cycles).
Receives: Drug: Tislelizumab-jsgr; Drug: Cisplatin; Drug: Albumin-Bound Paclitaxel; Radiation: Radiotherapy

What is being measured

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

  1. 1 year Event-free Survival rate (1y-EFS rate)

    EFS is the time from the starting date of neoadjuvant therapy to the date of first record of any of the following events: radiographic disease progression; local or distant progression or recurrence as assessed with imaging or biopsy as indicated; or death due to any cause. Radiographic disease progression during neoadjuvant phase that precludes surgery will be considered an event; a secondary malignancy will not be considered an event.

    Measured: 1 year

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

    Measured: Up to 30 days post-neoadjuvant

  2. Pathological Complete Response (pCR)

    Pathological complete response (pCR) is measured as the percentage of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.

    Measured: Up to 30 days post-surgery

  3. Major Pathological Response (MPR)

    The percentage of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.

    Measured: Up to 30 days post-surgery

  4. Overall Survival (OS)

    OS was defined as the time from starting date of neoadjuvant therapy to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.

    Measured: Up to 5 years

  5. Percentage of Participants Experiencing An Adverse Event (AEs)

    Percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy

    Measured: through study completion, an average of 2 years

  6. Local Recurrence-free Survival (LRFS)

    Percentage of patients in a treatment group who are alive without local recurrence.

    Measured: through study completion, an average of 5 years

  7. Distant Metastases-free Survival (DMFS)

    DMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first.

    Measured: through study completion, an average of 5 years

Timeline

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

  1. First posted10 Dec 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2029 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06725498
Sponsor's protocol ID
TREC2023-KY073
Status last verified
Aug 2024
First submitted
18 Nov 2024
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
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-jsgr, Cisplatin and Albumin-Bound Paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Beijing Tongren 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 11 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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?

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?

Contact Xiaohong Chen, Dr. (+86-10-58266699, trchxh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 year Event-free Survival rate (1y-EFS rate) (time frame: 1 year). 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 NCT06725498.

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 10 Dec 2024.

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