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This study is a prospective, randomized ,multicencter, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The purpose of this study is to assess the safety and efficacy of Mecapegfilgrastim Combined With Adebrelimab and 5- fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT)) as Neoadjuvant Therapy in Resectable gastric and gastroesophageal junction cancer
After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomly divided into trial group A and trial group B: Trial group A receive the combination therapy of Mecapegfilgrastim combined with Adebrelimab and FLOT, and trial group B receive the combination therapy of Adebrelimab combined with FLOT, two weeks a cycle, surgery was performed after 4 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT | Experimental | Mecapegfilgrastim:(6 mg, HD, d3) Adebrelimab (1200 mg,iv d1) Docetaxel(50 mg/m2 iv gtt d1) Oxaliplatin (85 mg/m2 iv gtt d1) 5- fluorouracil, leucovorin (200 mg/m2 iv gtt d1) for 4 cycles (every 2 weeks) before surgery. |
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| Arm B: Adebrelimab plus FLOT | Experimental | Adebrelimab (1200 mg,iv d1) Docetaxel(50 mg/m2 iv gtt d1) Oxaliplatin (85 mg/m2 iv gtt d1) 5- fluorouracil, leucovorin (200 mg/m2 iv gtt d1) for 4 cycles (every 2 weeks) before surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mecapegfilgrastim | Drug | 6 mg,HD d3,every 2weeks (Q2W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) | The pCR refers to the proportion of subjects with no residual tumor cells in the primary lesion based on Becker Grade 1a. | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response (MPR) | The proportion of subjects with resectable gastric cancer after neoadjuvant therapy who have less than 10% residual tumor cells in the primary lesion. | From enrollment to the end of treatment at 12weeks |
| R0 Resection Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210000 | China |
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Interventional Study Model.
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| Adebrelimab | Drug | Adebrelimab:1200 mg,iv d1,every2 weeks (Q2W) |
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| Docetaxel | Drug | Docetaxel:50 mg/m2 iv gtt d1,every 2 weeks (Q2W) |
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| Oxaliplatin | Drug | Oxaliplatin :85 mg/m2 iv gtt d1,every2 weeks (Q2W) |
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| 5-Fluorouracil (5-FU) | Drug | 5-FU :2600 mg/m2 ,intravenous infusion, 24h ,d1,every 2 weeks (Q2W) |
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| Leucovorin (LV) | Drug | LV:200 mg/m2 iv gtt d1,every 2 weeks (Q2W) |
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The R0 resection rate refers to the proportion of subjects with resectable gastric cancer who complete R0 resection in the total number of subjects operated. R0 resection refers to microscopically negative margins. |
| From enrollment to the end of treatment at about 12 weeks |
| Event-free Survival (EFS) | The EFS refers to the time from the date of the random enrollment to disease progression, recurrence, or death (whichever occurs first). | 24 months |
| Overall Survival (OS) | The OS refers to the time from the date of the random enrollment to death from any cause. For subjects who are still alive at the time of the last follow-up, OS is censored at the time of the last follow-up. For subjects lost to follow-up, their OS is censored at the last confirmed alive time before loss to follow-up. The censored OS is defined as the time from the date of the first dose to the time of censoring. | 36 months |
| Chemotherapy completion rate | The proportion of patients who completed 4 cycles of FLOT chemotherapy in the total number of enrolled patients | 8 weeks |
| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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