Evaluating the efficacy and safety of SHR-1701 combined with chemotherapy for the perioperative treatment of locally advanced resectable Siewert type II adenocarcinoma of the esophagogastric junction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA\<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
pathological Complete Response(pCR)
No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.
Time frame: 1-year
R0 resection rate
The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.
Time frame: 1-year
Major Pathological Response(MPR)
Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%.
Time frame: 1-year
PFS(Progression-Free Survival)
The time from the start of treatment until tumor progression or death from any cause.
Time frame: 3 years
OS(Overall Survival )
Time from enrollment to death from any cause. For subjects who were still alive at the time of the last follow-up, their overall survival was censored on the date of the last follow-up.
Time frame: 3 years
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