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

NCT ID: NCT05476965

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

induction therapy; surgery; radiotherapy

Intervention Type: COMBINATION_PRODUCT

Radiotherapy: de-escalation radiotherapy or standard radiotherapy

Arm 2

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

Group Type: ACTIVE_COMPARATOR

induction therapy; surgery; radiotherapy

Intervention Type: COMBINATION_PRODUCT

Radiotherapy: de-escalation radiotherapy or standard radiotherapy

Interventions

induction therapy; surgery; radiotherapy

Radiotherapy: de-escalation radiotherapy or standard radiotherapy

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Between the age of 18 to 65.

2. 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.

3. 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.

4. ECOG performance status 0 or 1.

5. Normal Organ function

1. Leukocytes ≥ 4×109/L

2. Hemoglobin ≥ 90 g/L

3. Platelets ≥ 100×109/L

4. Total bilirubin ≤ 1.5x upper limit of normal

5. Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) ≤ 2.5x upper limit of normal

6. Alkaline phosphatase ≤ 2.5x upper limit of normal

7. Creatinine clearance > 60 mL/min

Exclusion Criteria

7. 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.

8. 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.

1. Positive HBsAg and HBV DNA > 1×103 copies/ml, or anti-HCV antibody positive.

2. Positive anti-HIV antibody or diagnosed as AIDS.

3. 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).

4. 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.

5. Diagnosis of interstitial pneumonia or pneumonia and receiving oral or intravenous steroid therapy in the past 1 year.

6. Receiving systemic glucocorticoid (10 mg prednisone per day) therapy or any other form of immunosuppressive therapy (excluding inhaled or topical corticosteroids).

7. 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.

8. Pregnant or breastfeeding female patients (women of childbearing potential must have urine pregnancy test).

9. 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.

10. Allergic to macromolecular protein or any component of anti-PD1 antibody.

11. Active infection requiring systemic therapy no more than one week.

12. Has received a live vaccine within 30 days before administrating anti-PD-1 antibody.

13. organ transplantation history.

14. Other situations assessed by the investigator that may endanger patient safety or compliance, such as serious diseases requiring treatment (including mental diseases), serious abnormal test results, or with other family or social high-risk factor.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hubei Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu Qian

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Desheng Hu, Dr.

Role: STUDY_CHAIR

Hubei Cancer Hospital

Locations

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuan Wu, Dr.

Role: CONTACT

344351420@qq.com

862787670318

Facility Contacts

Yuan Wu, Dr.

Role: primary

344351420@qq.com

862787670318

Other Identifiers

HN010815

Identifier Type: -

Identifier Source: org_study_id