Selected De-escalation Radiotherapy for Postoperative Head and Neck Squamous Cell Carcinoma

NCT05476965 | Unknown Phase 2 DMC

• 1 other identifier: HN010815
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking to see if sintilimab, an anti-PD-1 McAb given with cisplatinum and paclitaxel (2 chemotherapy agents) during induction therapy in advanced head and neck squamous cell carcinoma can significantly shrink the subject's cancer, then de-escalation radiotherapy can be used.

Conditions

Head and Neck Squamous Cell Carcinoma; Radiotherapy; Immunotherapy; Surgery

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The objective is to intensify induction chemotherapy with the addition of anti-PD-1 McAb sintilimab aimed at acquiring a higher postoperative pCR.

  3 weeks

Secondary Outcomes (4)

• Radiation dose of normal organs and treatment-related adverse events

  12 months

• Safety of sintilimab in combination with chemotherapy

  12 months

• Functional assessment of cancer therapy scale head and neck quality of life assessments

  6 months after the use of anti-PD-1 McAb sintilimab

• Progression free survival (PFS) in 2 years

  24 months

Study Arms (2)

Arm 1

EXPERIMENTAL

De-escalation radiation following induction therapy and surgery Drug: Cisplatinum Drug: Paclitaxel Drug: Sintilimab Surgery: Surgery Radiation: De-escalation radiotherapy

Combination Product: induction therapy; surgery; radiotherapy

Arm 2

ACTIVE COMPARATOR

Arm 2 Standard radiation following induction therapy and surgery Drug: Cisplatinum Drug: Paclitaxel Drug: Sintilimab Surgery: Surgery Radiation: Standard radiotherapy

Combination Product: induction therapy; surgery; radiotherapy

Interventions

induction therapy; surgery; radiotherapy COMBINATION_PRODUCT

Radiotherapy: de-escalation radiotherapy or standard radiotherapy

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• Between the age of 18 to 65.
• Newly diagnosed pathologically confirmed locally advanced head and neck squamous cell carcinoma, including oral cancer, oropharyngeal cancer, laryngeal cancer, while nasopharyngeal carcinoma was excluded. The P16 status of oropharyngeal carcinoma is known.
• Locally advanced resectable head and neck tumors (stage III and stage IV) were enrolled and radiotherapy is expected to be performed within 4 or 6 weeks after surgery. Tumor staging is based on AJCC/UICC 8th Edition. All the patients must undergo the following examinations to determine the tomor stage before the treatment: complete medical history, physical examination, blood and biochemical routine, head and neck CT or MRI, chest CT scan, abdominal ultrasound and bone scan. In addition, 18F PET/CT can be used to replace the last three imaging examinations mentioned above.
• ECOG performance status 0 or 1.
• Normal Organ function
• Leukocytes ≥ 4×109/L
• Hemoglobin ≥ 90 g/L
• Platelets ≥ 100×109/L
• Total bilirubin ≤ 1.5x upper limit of normal
• Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) ≤ 2.5x upper limit of normal
• Alkaline phosphatase ≤ 2.5x upper limit of normal
• Creatinine clearance \> 60 mL/min

You may not qualify if:

• Patients must sign an informed consent form prior to study entry and they must be willing to comply with the visit, treatment protocol, laboratory examination and other requirements included in the study protocol.
• Women of childbearing potential and men with fertility partners must agree to follow instructions for methods of contraception (such as condoms or contraceptive drugs) from screening to 1 years after completing treatment.
• Positive HBsAg and HBV DNA \> 1×103 copies/ml, or anti-HCV antibody positive.
• Positive anti-HIV antibody or diagnosed as AIDS.
• patients with active tuberculosis history (whether treated or not) in the past 1 years, or with a history of tuberculosis more than 1 years (except those who had received regular anti-tuberculosis treatment).
• Has active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary diseases, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Type I diabetes, hypothyroidism requiring hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) are not included.
• Diagnosis of interstitial pneumonia or pneumonia and receiving oral or intravenous steroid therapy in the past 1 year.
• Receiving systemic glucocorticoid (10 mg prednisone per day) therapy or any other form of immunosuppressive therapy (excluding inhaled or topical corticosteroids).
• Uncontrolled heart disease, such as: heart failure, NYHA level ≥ 2; instability Angina pectoris; myocardial infarction history in the past 1 year; supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention.
• Pregnant or breastfeeding female patients (women of childbearing potential must have urine pregnancy test).
• Suffering from other malignant tumors at previously or currently. Additionally, well treated non melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer are not included.
• Allergic to macromolecular protein or any component of anti-PD1 antibody.
• Active infection requiring systemic therapy no more than one week.
• Has received a live vaccine within 30 days before administrating anti-PD-1 antibody.
• organ transplantation history.

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Neoadjuvant Therapy; Surgical Procedures, Operative; Radiotherapy

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)

Combined Modality Therapy; Therapeutics

Study Officials

• Desheng Hu, Dr.

  Hubei Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Yuan Wu, Dr.

CONTACT

862787670318; 344351420@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2024
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

CN (1)