Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701+SOX | Experimental | 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701+SOX | Drug | 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; |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological Complete Response(pCR) | No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples. | 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. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response(MPR) | Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%. | 1-year |
| PFS(Progression-Free Survival) |
Not provided
Inclusion Criteria:
1.Age:18-75 years old, male or female; 2.Pathologically confirmed Siewert Type II adenocarcinoma of the gastroesophageal junction; 3.Clinical stage cT3-4aN1-3M0; 4.Low to moderate HER2 expression or no expression (IHC 2+ and FISH- / IHC 1+ / IHC -); 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.At least one measurable lesion (according to RECIST 1.1 criteria); 7.Expected survival ≥ 3 months; 8.Normal functioning of major organs, i.e. meeting the following criteria:
routine blood tests:
biochemical examination:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziqiang Tian | Contact | 18531118000 | tizq12@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ziqiang Tian | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The time from the start of treatment until tumor progression or death from any cause.
| 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. | 3 years |