Stomach Neoplasm
Conditions
Brief summary
The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. This is a one-arm, open and prospective phase II clinical study. Recruit patients who have been diagnosed with advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction and have not received systematic treatment.
Detailed description
The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. Bevacizumab is an anti-vascular endothelial growth factor (VEGF) targeted therapy drug. It is doubtful whether the low dose of bevacizumab in gastric cancer patients leads to poor curative effect. Now the treatment of advanced gastric cancer has come to the era of immunotherapy. The chemotherapy regimen of daclizumab combined with CAPEOX has been proved to be effective in clinical studies. No clinical study has confirmed the safety and efficacy of CAPEOX regimen combined with sintilimab and bevacizumab.
Interventions
COMBINATION_PRODUCTCapeox regimen combined with Sintilimab and Bevacizumab
Stage Ib：Oxaliplatin +Capecitabine Tablets +Sintilimab +Bevacizumab Stage II：Bevacizumab (the dose determined in phase Ib clinical study)，the dosage of other drugs was the same as before
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histological or cytological diagnosis confirmed adenocarcinoma of stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) 2. Imaging and surgical evaluation of unresectable recurrent or metastatic patients 3. The expected survival time was more than 3 months 4. The age is between 18 and 70 years old, both male and female 5. No systematic treatment has been given to patients with advanced or metastatic gastric and esophagogastric junction adenocarcinoma.If the patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy and chemotherapy), the last treatment must be completed at least 6 months before randomization, and there is no recurrence or disease progression at the time of treatment.Palliative radiotherapy was allowed, but it must be completed at least 2 weeks before the first study treatment.Subjects were allowed to receive anti-tumor traditional Chinese medicine preparations in the past, but they must be discontinued at least 2 weeks before randomization 6. Eastern Cooperative Oncology Group(ECoG) - 1 physical status 7. At least one lesion can be evaluated according to RECIST 1.1 criteria 8. It can provide pathological tissues or fresh pathological tissues that are filed within 6 months after the signature of informed consent for screening, and can obtain the test results. For the slices filed within 6 months before randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received after obtaining the samples 9. The function of the main organs is normal, that is to say, it meets the following standards: 1. Blood routine examination (no blood transfusion within 14 days before screening) 2. Hemoglobin ≥ 90 g / L; 3. Absolute neutrophil count (ANC) ≥ 1.5×109/L; 4. Platelet count ≥ 75×109/L; Blood biochemical test (albumin was not used within 14 days before screening) 5. Albumin ≥ 28 g / L; 6. Total bilirubin ≤ 1.5×Upper limit of normal value (ULN); 7. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3×ULN; If there is liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5×ULN 8. Creatinine ≤ 1.5×ULN;Coagulation function: 9. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN; 10. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN 10. For sections filed in the first 6 months of randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received since sample acquisition 11. Acute toxicity caused by previous anti-tumor treatment or surgery was relieved to grade 0-1 (according to ncictcae 5.0) or to the level specified in the inclusion /
Exclusion criteria
12. Female subjects of childbearing age were required to conduct a serum pregnancy test within 3 days before the start of the study, and the results were negative, and they were willing to use a medically recognized high-efficiency contraceptive method (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug;For male subjects whose partners are women of childbearing age, they should be sterilized by surgery or agree to use effective contraceptive methods during the study and within 3 months after the last study administration 13. With my consent and signed the letter of understanding, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the appropriate dose of Bevacizumab | 1.5-3months | According to the incidence of dose-limited toxic dose -limiting toxicity (DLT) after 2 and 4 cycles of Ib phase treatment, the appropriate dose of Bevacizumab combination was determined. |
| the objective Response Rate (ORR) of the experimental group. | 2years | The main purpose of phase II is the objective Response Rate (ORR) of the experimental group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival（PFS） | 1-2years | Refers to the time between the patient's admission to the treatment and the disease progression |
| overall survival (OS) | 1-3years | Refers to the time from admission to treatment to death of patients |
| disease control rate (DCR) | 1-3years | Refers to the proportion of people who receive this program in the whole patient population and achieve complete response ,partial response or stable disease and last for a period of time |
Countries
China
Contacts
Primary ContactLiu Ming, Professor
Backup ContactDai Ruihong, doctor
Outcome results
None listed