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

NCT06699498 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-SR-421
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma; Neoadjuvant Therapy; PD-L1; Anlotinib

Outcome Measures

Primary Outcomes (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%.

  up to 9 weeks

Secondary Outcomes (6)

• Objective response rate (ORR) evaluated by RECIST 1.1

  up to 9 weeks

• Pathological complete remission rate (pCR)

  up to 9 weeks

• Disease-free survival rate at 2 years

  from enrollment to the end of the second year

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

  from enrollment to the end of the second year

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

  from enrollment to the end of the second year

Study Arms (1)

Treatment group

EXPERIMENTAL

The 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.

Drug: Benmelstobart; Drug: Anlotinib; Drug: Cisplatin; Drug: Paclitaxel for Injection （Albumin Bound）

Interventions

Benmelstobart DRUG

1200mg, D1, IV,q3w

Also known as: TQB2450

Treatment group

Anlotinib DRUG

10mg，D1-14，po，q3w

Treatment group

Cisplatin DRUG

60mg/m2， D1， IV，q3w

Treatment group

Paclitaxel for Injection （Albumin Bound） DRUG

260mg/m2，IVgtt ，D1，q3w

Also known as: Albumin Bound-Paclitaxel

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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:

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

anlotinib; Cisplatin; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Central Study Contacts

Yiqian Liu, PhD

CONTACT

+86-138 1380 4568

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: November 21, 2024
• Study Start: December 3, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)