Toripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC (NCT04624308) | Clinical Trial Compass
UnknownPhase 2
Toripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC
China81 participantsStarted 2020-10-30
Plain-language summary
TPF is the standard regime of inductive chemotherapy for squamous carcinoma of head and neck. If the primary tumor shrinks obviously (complete remission or \>75% partial remission )after inductive chemotherapy, CCRT is suggested as the definitive therapy, for the tumor is sensitive to chemotherapy. If the primary tumor shrinks a little or progresses after inductive chemotherapy, operation is suggested as the definitive therapy to get a longer survival.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 18y ≤age≤65y;
✓. ECOG：0-1；
✓. Histology：squamous cell carcinoma, located in hypopharynx;
✓. clinical stage: cT1N1-3M0、cT2-3N0-3M0，organ-preservation-intent regime is made after multidisciplinary treatment(MDT) discussion. Efficacy evaluation will be made according to RECIST 1.1 after inductive chemotherapy, and the following treatment will be chosen according to the results of efficacy evaluation.
✓. never received any previous treatment, including radiotherapy, chemotherapy, or immune therapy, et al.
✓. at least one measurable lesion (RECIST 1.1 criteria).
✓. expected survival ≥6 months.
✓. no contraindications of radiotherapy, chemotherapy and immune therapy.
Exclusion criteria
✕. other histology cancers located in hypopharynx.
✕. synchronous or metachronous cancers located in other sites.