Head and Neck Squamous Cell Carcinoma, Immunotherapy, Radiotherapy, Surgery
Conditions
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.
Interventions
COMBINATION_PRODUCTinduction therapy; surgery; radiotherapy
Radiotherapy: de-escalation radiotherapy or standard radiotherapy
Sponsors
Hubei Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 6. Normal thyroid function, amylase, pituitary function, inflammation and infection index, myocardial enzyme, and ECG. For patients with abnormal ECG or cardiovascular history but not meet the
Exclusion criteria
, a cardiac color ultrasound is needed, and the results should be normal. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response rate (pCR) | 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation dose of normal organs and treatment-related adverse events | 12 months | Assess the radiation dose of normal organs between the de-escalation radiotherapy group or standard radiotherapy group. Furthermore, toxicities reaction between two groups also been compared. Adverse events were any untoward medical occurrence in a participant who received study interventions without regard to possibility of causal relationship. |
| Safety of sintilimab in combination with chemotherapy | 12 months | Evaluate the safety of sintilimab in combination with chemotherapy followed by surgery and radiotherapy in advanced head and neck squamous cell carcinoma patients. |
| Functional assessment of cancer therapy scale head and neck quality of life assessments | 6 months after the use of anti-PD-1 McAb sintilimab | Evaluate quality of life in all patients. The specific modules H&N35 in Quality of Life Questionnaire Core 30 module (QLQ-C30) and European Organization for Research and Treatment of Cancer (EORTC) and Functional Assessment of Cancer Therapy (FACT) H&N V4.0 were used. Both of them are standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. |
| Progression free survival (PFS) in 2 years | 24 months | PFS was defined as the time from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Comparing the PFS at 24 months after completing chemotherapy, surgery, and radiotherapy between arm 1 and arm 2. |
Countries
China
Contacts
Primary ContactYuan Wu, Dr.
Outcome results
None listed