About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HB≥90g/L;
ANC≥1.5×109/L;
PLT≥100×109/L;
ALT and AST<2.5ULN(liver metastasis: ALT and AST<5ULN);
Disqualifiers
Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);
Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;
Cardia or pyloric obstruction;
Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;
Trial design
Single group
Treatments tested in this trial
SHR-1701+SOX
DrugSHR-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;
Treatment groups
Trial outcomes
Primary outcomes
pathological Complete Response(pCR)
No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.
R0 resection rate
The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.
Secondary outcomes
Major Pathological Response(MPR)
Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%.
PFS(Progression-Free Survival)
The time from the start of treatment until tumor progression or death from any cause.
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.
Sponsors and contacts
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