24
Participants
Start Date
December 24, 2024
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2027
Toripalimab
Toripalimab will be administered 240 mg intravenously every three weeks in combination with the induction chemotherapy regimen for 3 cycles, and for 9 cycles as adjuvant treatment following radiation as specified in the overall sequential treatment plan.
Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation
"Radiation treatment will be initiated 3-6 weeks following day 1 of the last induction cycle using institutional standards of care and support as follows:~Intensity modulated radiotherapy, 70 Gy in 33 fractions M-F once daily plus cisplatin 40 mg/m2 IV weekly for up to 7 doses.~Following the completion of concurrent chemoradiation, capecitabine will be administered using institutional standards of care as follows:~Capecitabine 650 mg/m2 PO BID x 12 months beginning 12 to 16 weeks following the end of radiation treatment. Dose reductions and discontinuance of capecitabine will be according to the standard of care applied at the treating institution.~Adjuvant Toripalimab 240 mg IV q 21d x 9 maximum doses will be initiated concurrently with the initiation of adjuvant capecitabine, beginning 12-16 weeks following the end of radiation."
RECRUITING
Stanford University, Palo Alto
Stanford University
OTHER