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Head and Neck Squamous Cell CarcinomaPhase 2NCT06699498

Neoadjuvant Therapy of Targeted Immunotherapy Combined With Chemotherapy for Locally Advanced HNSCC

A Phase 2 study testing Benmelstobart, Anlotinib and Cisplatin in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Therapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Exploring the safety and effectiveness of neoadjuvant therapy using benmelstobart combined with anlotinib and chemotherapy for locally advanced squamous cell carcinoma of the head and neck patients. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Benmelstobart, Anlotinib and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
3 Dec 2024to 1 Dec 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years old;
  • ECOG PS score of 0-1;
  • Pathologically confirmed, untreated patients with head and neck squamous cell carcinoma, classified as stage III, IVa according to AJCC (8th edition), including hypopharyngeal cancer, laryngeal cancer, and oral cancer;
  • Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug, or have undergone sterilization. For male participants, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug, or have undergone surgical sterilization;
  • Signed the informed consent form with their own consent and have good compliance.

Who cannot join

  • Received previous PD-1/PD-L1/CTLA-4 antibody therapy;
  • Tumor invasion of major blood vessels;
  • Patients requiring systemic use of glucocorticoids (>10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days before administration or during treatment. Inhaled or local use of steroids and adrenal corticosteroids at doses >10mg/day prednisone equivalent are allowed in the absence of active autoimmune diseases. Adrenal corticosteroid replacement therapy not exceeding 10mg/day prednisone equivalent is also allowed;
  • Presence of any history of active immune or autoimmune diseases, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Active or uncontrolled severe infection (≥NCI CTCAE v5.0 Grade 2 infection) within 4 weeks before enrollment;
  • Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), tendency to bleed, or receiving thrombolytic or anticoagulant therapy; Note: Small doses of heparin (adult daily dose of 6,000-12,000 U) or small doses of aspirin (daily dose ≤ 100 mg) for preventive purposes are allowed provided that the international normalized ratio of prothrombin time (INR) is ≤ 1.5;
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  • Patients with imaging showing tumor invasion of vital perivascular tissue or whose tumor is likely to invade vital blood vessels during subsequent study and cause fatal bleeding as judged by the investigator;
  • Patients with any signs or history of bleeding diathesis, regardless of severity;
  • patients with any bleeding or hemorrhage event ≥ CTCAE Grade 2 within 4 weeks before enrollment, presence of unhealed wounds, ulcers, or fractures;
  • Abnormalities in major organ functions:
  • Abnormal blood routine examination (received blood transfusion or blood products, or used G-CSF and other hematopoietic growth factors for correction within 14 days):
  • Hemoglobin (HB) < 90g/L;
  • Absolute neutrophil count (ANC) < 1.5 × 109/L;
  • Platelets (PLT) < 100 × 109/L;
  • Abnormal biochemical examination:
  • <!-- -->
  • Total bilirubin (TBIL) > 1.5 * upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 × ULN;
  • Serum creatinine (Cr) > 1.5 × ULN or creatinine clearance rate (CCr) < 60ml/min; ③ Abnormal Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) < normal lower limit (60%);
  • Abnormal thyroid function: TSH > upper limit of normal (ULN) with abnormal T3 and T4 levels;
  • Renal insufficiency: Urine routine test indicating urine protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g;
  • Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms), and ≥ Grade 2 congestive heart failure (New York Heart Association (NYHA) classification) within 6 months before enrollment;
  • Diagnosed with other malignancies within 3 years before enrollment;
  • Patients with any severe and/or uncontrolled diseases, including:
  • <!-- -->
  • Patients with uncontrolled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 430ms), and Grade I cardiac insufficiency (NYHA classification);
  • Active or uncontrolled severe infections;
  • Diseases such as cirrhosis, decompensated liver disease, active hepatitis HBV or HCV;
  • Poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L);
  • Urine routine test indicating urine protein ≥ 2+, and confirmed 24-hour urine protein > 1.0g;
  • Presence of long-term unhealed wounds or fractures;
  • Pulmonary hemorrhage graded > 1 by NCI CTC AE V4.0 within 4 weeks before enrollment; hemorrhage in other locations graded > 2 by NCI CTC AE V4.0 within 4 weeks before enrollment; patients with a tendency to bleed (such as active peptic ulcer) or receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or similar drugs;
  • History of gastrointestinal perforation and/or fistula within 6 months before selected treatment; or history of arterial/venous thrombotic events such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis, and pulmonary embolism;
  • Imaging showing tumor invasion of vital blood vessels or patients whose tumor is likely to invade vital blood vessels and cause fatal bleeding during subsequent study as judged by the investigator;
  • Clinically significant ascites, including any ascites detectable by physical examination, ascites that has been treated or still requires treatment, and patients with only a small amount of ascites shown by imaging but asymptomatic are eligible;
  • Uncontrolled metabolic disorders or other non-malignant tumor organ or systemic diseases or secondary reactions to cancer that can lead to high medical risks and/or uncertainty in survival evaluation;
  • Participated in other anti-cancer drug clinical trials within 4 weeks before enrollment;
  • Patients with a history of psychotropic drug abuse who cannot quit or have mental disorders;
  • Any accompanying diseases or other conditions that the investigator judges as seriously endangering the safety of the patient, potentially confusing the study results, or affecting the patient's completion of this study.

Trial locations and contacts

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

Yiqian Liu, PhD contact

+86-138 1380 4568

China1 site

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Yiqian Liu, PHD, +86-138 1380 4568, Drzilingliu@163.com

    Yiqian Liu

Other trials in China

About this study

Official title: Phase II Clinical Study of Neoadjuvant Therapy With Benmelstobart Combined With Anlotinib and Chemotherapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Exploring the safety and effectiveness of neoadjuvant therapy using benmelstobart combined with anlotinib and chemotherapy for locally advanced squamous cell carcinoma of the head and neck patients.

Read the detailed description

This is a single-center, Phase II study designed to treat patients with stage III/IVa head and neck squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy involves the administration of benmelstobart combined with anlotinib and chemotherapy for three cycles (21 days per cycle). Surgical resection will be performed within 2 weeks after the completion of neoadjuvant therapy. Tumor tissue samples and blood samples will be collected post-surgery for ctDNA detection. If the post-surgical ctDNA test result is positive, the patient will receive standard adjuvant therapy combined with benmelstobart, along with benmelstobart maintenance therapy. If the result is negative, the patient will receive standard adjuvant therapy alone.

Being tested
Benmelstobart, Anlotinib, Cisplatin, Paclitaxel for Injection （Albumin Bound）
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.

  • BenmelstobartDrug

    Also called TQB2450

    1200mg, D1, IV,q3w

  • AnlotinibDrug

    10mg，D1-14，po，q3w

  • CisplatinDrug

    60mg/m2， D1， IV，q3w

  • Paclitaxel for Injection （Albumin Bound）Drug

    Also called Albumin Bound-Paclitaxel

    260mg/m2，IVgtt ，D1，q3w

Study groups in NCT06699498
Study groupRoleWhat they receive
Treatment groupExperimentalThe treatment group received neoadjuvant therapy with benmelstobart, anlotinib, cisplatin, and albumin-bound paclitaxel for a total of 3 cycles. Surgery was performed within 2 weeks after completing neoadjuvant therapy. Adjuvant therapy was initiated within 6 weeks after surgery.
Receives: Drug: Benmelstobart; Drug: Anlotinib; Drug: Cisplatin; Drug: Paclitaxel for Injection （Albumin Bound）

What is being measured

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

  1. Major pathological response，MPR

    It is defined as pathological examination shows that the tissue sample has ≤10% viable tumor, i.e. the area of residual viable tumor cell region/surface area of tumor bed ≤10%.

    Measured: up to 9 weeks

Secondary outcomes (6)

  1. Objective response rate (ORR) evaluated by RECIST 1.1

    The proportion of patients whose tumors have shrunk to a certain extent and maintained for a certain period of time, including cases of complete response (CR) and partial response (PR). The tumor's objective response is assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).

    Measured: up to 9 weeks

  2. Pathological complete remission rate (pCR)

    Defined as pathological examination showing 0% viable tumor tissue (0% RVT); calculate the proportion of subjects achieving pathological complete remission (pCR).

    Measured: up to 9 weeks

  3. Disease-free survival rate at 2 years

    The proportion of subjects who experienced disease recurrence or died (from any cause) from enrollment to the end of the first year, out of the total number of subjects.

    Measured: from enrollment to the end of the second year

  4. Locoregional recurrence-free survival rate (LRFS) at 2 years

    The proportion of subjects who did not experience local or regional lymph node recurrence or death from enrollment to the end of the second year, out of the total number of subjects.

    Measured: from enrollment to the end of the second year

  5. Distant metastasis-free survival rate (DMFS) at 2 years

    The proportion of subjects who did not experience distant metastasis from enrollment to the end of the second year, out of the total number of subjects.

    Measured: from enrollment to the end of the second year

  6. Overall survival rate (OS) at 2 years

    The proportion of subjects who died from any cause from enrollment to the end of the second year, out of the total number of subjects.

    Measured: from enrollment to the end of the second year

Timeline

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

  1. First posted21 Nov 2024
  2. Study start3 Dec 2024 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06699498
Sponsor's protocol ID
2024-SR-421
Status last verified
Nov 2024
First submitted
16 Jun 2024
Last updated
21 Nov 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 Benmelstobart, Anlotinib and Cisplatin in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Therapy, run by The First Affiliated Hospital with Nanjing Medical University 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 5 inclusion and 39 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: opening soon, as of the sponsor's last update on 21 Nov 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 Yiqian Liu, PhD (+86-138 1380 4568), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological response，MPR (time frame: up to 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 NCT06699498.

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 21 Nov 2024.

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