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To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes | Experimental |
| |
| Oxplatin and S-1 for Immune Genotypes | Active Comparator |
| |
| Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes | Experimental |
| |
| Oxplatin and S-1 for Mesenchymal Genotypes | Active Comparator |
| |
| Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes | Experimental |
| |
| Oxplatin and S-1 for Classic Genotypes | Active Comparator |
| |
| Oxplatin and S-1 for Metabolic Genotypes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The surgical procedure was total or subtotal gastrectomy with 3 weeks after total neoadjuvant therapy. | 4 months |
| Disease control rate | 4 months |
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Inclusion Criteria:
Age from 18 to 75 years, all sex;
Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology;
CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.;
measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.(CT scan of tumor lesion length≥10mm,CT scan short diameter of lymph node≥15mm,scan slice thickness 5mm);
ECOG(Eastern Cooperative Oncology Group)PS(Performance Status):0-1 scores;
the expected survival time is more than 12 weeks;
the main organ function is normal, which should meet the following criteria: (1)(1)blood routine examination standards should be met(no blood transfusion within 14 days)
women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug.;
No other clinical studies were conducted before and during the treatment; participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang-Ming Huang, PhD | Contact | 8613805069676 | hcmlr2002@163.com | |
| Hualong Zheng, PhD | Contact | 18359190587 | 291167038@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang-Ming Huang, phD | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
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| Active Comparator |
|
| Oxaliplatin | Drug | Oxaliplatin for Injection 135mg/m2 /per day,ivgtt,in day1. Given once every 3 weeks. |
|
| S1 | Drug | S-1 was calculated according to body surface area , P.O., bid, d1-d14. And the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time |
|
| Apatinib Mesylate | Drug | Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday. |
|
| Nab paclitaxel | Drug | nab-paclitaxel One course will last 21 days. Given twice every 3 weeks at a dose of 260 mg/m2 in day 1 and day 8. |
|
| 1-year and 3-year OS/DFS | 1 and 3 years |
| adverse event | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | 3 years |
| overall postoperative morbidity rates | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. | 30 days |
| 30 days mortality rates | Defined as the event observed within 30 days after surgery. | 30 days |
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days |
| The prediction performance of Exosome contents (including proteins, nucleic acids) | Exosomes were isolated using a Backman Optima XPN-100 instrument. The exosomes morphology was characterized using a HT7700 transmission electron microscope (Hitachi, Co. Ltd., Japan). Fluorescent spectra were recorded using a F96 Pro fluorospectrophotometer (Shanghai Lengguang Technology). The concentration and size distribution of the exosomes were quantified using nanoparticle tracking analysis (NanoSight NS 300, Malvern Instrument). The obtained results were subjected to biostatistical analysis, such as heat map generation, ROC curve establishment, and confusion matrix. | 3 years |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| C553458 | apatinib |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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