The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
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.
Stanford University
Palo Alto, California, United States
RECRUITINGInduction chemotherapy completion rate
Induction chemotherapy completion rate, defined as the proportion of patients who complete three cycles of chemoimmunotherapy within 12 weeks of initiation. Completion is defined for induction as receiving all 3 cycles as planned, including protocol specified dose reduction and delays. .
Time frame: 3 years
Radiation completion rate
Radiation completion rate, defined as the proportion of patients who complete specified radiation within 8 weeks of radiation initiation. Radiation completion is defined as completion of planned doses of radiation.
Time frame: 3 years
Overall Response (ORD) rate following induction
OR rate following induction, defined as the proportion of patients who achieve at least a RECIST defined PR within 12 weeks of induction chemotherapy initiation.
Time frame: 3 years
Complete Response (CR) rate following radiation
CR rate following radiation, defined as the proportion of patients who achieve a RECIST defined CR within 16 weeks following the end of radiation therapy.
Time frame: 3 years
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