Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
Conditions
Interventions
Treatment Group:Chemotherapy plus Toripalimab Augmented by Hypofractionated Radiotherapy
Sponsors
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 65 years of age, regardless of sex. 2. Histologically- or cytologically-confirmed recurrent/ metastatic head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, or larynx), as well as patients with distant metastasis at first diagnosis, considered incurable by local treatment. 3. No prior systemic therapy administered in the recurrent/ metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease). 4. Exist at least one meatastatic or primary tumor could receive hypofractionated radiotherapy. 5. All cases must have measurable disease as defined in RECIST 1.1 excluding radiotherapy lesions. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Demonstrate adequate organ function as defined below, with all screening labs to be obtained within 28 days prior to registration (1) blood routine examination criteria should be met (no blood transfusion or blood products within 14 days): a) Hemoglobin (Hgb) >= 9 g/dL b) Absolute Neutrophil Count (ANC) >= 1.5 K/mm3 c) Platelets >= 80 K/mm3 (2) biochemical examination shall meet the following criteria: a) Bilirubin = 50 cc/min using the Cockcroft-Gault formula 8. Can provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable. HPV status must be done for oropharyngeal cancer. 9. Sign a written informed consent form prior to the conduct of any pilot-related activities, 10. Able to comply with the research plan judged by the researcher, 11. Pregnancy test negative at screening (for women with fertility) 12. Fertile men and women at risk of fertility and pregnancy must agree to use two methods of birth control throughout the study period (at least one of which is considered to be efficient). Female patients who are not fertile (that is, at least one of the following criteria is met): -hysterectomy and / or bilateral ovariectomy and documented records; -the decline of ovarian function, which has been confirmed by medicine; -in the postmenopausal state, defined as at least 12 months of continuous menopause without other pathological or physiological reasons, and the status confirmed by serum follicle-stimulating hormone (FSH) levels is consistent with the postmenopausal state. 13. There is a signed and dated informed consent indicating that the patient (or legitimate representative, if permitted by the local guide / practice specification) has been informed of all relevant aspects of the study. 14. Must have read, understood, and provided written informed consent voluntarily. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
Exclusion criteria
Exclusion criteria: 1. Disease suitable for local therapy administered with a curative intent. 2. Progressive disease (PD) within six months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. 3. Participating in other clinical trials and drug treatments 4. Life expectancy of 10mg/d prednisone) or other immunosuppressants, in the absence of active autoimmune disease, Inhaled or local use of steroids and dosage > 10mg/ prednisone therapeutic dose of adrenocortical hormone replacement are allowed. 12. Active infection requiring systemic therapy. 13. Congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA >= 10K(copy number/ml or 2000IU/ml) or hepatitis C (positive for hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method). 14. Vaccinated with live vaccine within 4 weeks before the start of the study. 15. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 16. Pregnant or lactating women. 17. According to the researchers, the subjects had other factors that might have forced them to terminate the study, such as the need for combined treatment for other serious diseases, including mental illness, severe abnormalities in laboratory tests, and family or social factors that may affect the safety of the subjects or the collection of experimental data. 18. Active central nervous system metastases and/or carcinomatous meningitis. 19. Active pulmonary tuberculosis. 20. Severe infections that occurred within 4 weeks prior to the start of the study (including, but not limited to, hospitalization due to infection, bacteremia or complications of severe pneumonia). 21. Treated with systemic immunostimulating drugs (including, but not limited to, interferon or IL-2) within 4 weeks before the start of the study, or still w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Objective remission rate (ORR);Progression-free survival (PFS) rate at 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival rate at 1 year;Overall Survival rate at 2 year; | — |
Countries
China
Contacts
Public ContactKunyu Yang
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed