This study is to evaluate the efficacy and safety of domestic programmed death 1( PD-1) antibody (Camrelizumab for injection) combined with fluorouracil plus leucovorin, oxaliplatin, and albumin bound paclitaxel (Nab-POF) regimen in the treatment of patients with unresectable locally advanced or limited metastatic gastric cancer. The primary efficacy endpoint is R0 resection rate.
This is an open, single center, prospective phase II clinical study to evaluate the efficacy and safety of domestic PD1 antibody (Camrelizumab for injection) combined with Nab-POF regimen in the treatment of unresectable locally advanced or limited metastatic gastric cancer. This study will be carried out in our center, about 40 patients will be enrolled. Patients with unresectable locally advanced or limited metastatic gastric cancer who had not received any prior antitumor therapies were treated with domestic PD1 antibody (Caerelizumab for injection) commbined with mFLOT regimen, and human epidermal-growth-factor receptor 2 (HER-2) positive patients were treated with Herceptin. The efficacy of therapy was evaluated every 3 treatment cycles. After 6 cycles, surgical experts evaluated the resectability of the tumor, and the patients who were confirmed to be resectable received surgery within 3-6 weeks after immunochemotherapy. The patients with good postoperative recovery continued to receive the same immunochemotherapy in 3-6 weeks, and totally at most 12 cycles. Patients who were evaluated as progressive disease (PD) at any time withdrawn from the study as conversion failure.Patients who did not PD at 6 cycles of treatment but did not reach the criteria for R0 resection, continued to receive another 3 cycles of the prior chemotherapy. If resectable then, surgical treatment was performed, if still unresectable, the immunochemotherapy for transformation was evaluated as unsuccessful. The patients were treated according to the principle of palliative treatment until the disease progressed or intolerable toxicity. The efficacy and safety will be continuously monitored and evaluated throughout the study period (including a 30 day follow-up period). 40 cases were expected to be enrolled: 3-4 cases per month, completed in 1 year and finished in 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every three weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.
The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity.
Fudan University, Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
margin-free-(R0) resection rate
R0 resection was defined as no tumor identified on microscopic examination of proximal, distal,or circumferential margins.
Time frame: 6-9 weeks after immunochemotherapy
pathological complete response (pCR)
Time frame: 6-9 weeks after immunochemotherapy and R0 surgery
overall response rate (ORR)
Time frame: up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 24 months
sugery complications
sugery complications
Time frame: up to 2 months after the period of surgery
progression free survival (PFS)
randomisation to disease progression, relapse, or death; surgical morbidity and mortality
Time frame: up to 24 months
overall survival (OS)
Time frame: up to 24 months
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