Gastric Cancer
Conditions
Brief summary
The goal of this clinical trial is to evaluate the major pathological response (MPR) rate of locally advanced gastric cancer / gastroesophageal junction cancer treated with bemosumab combined with antiangiogenic drugs and neoadjuvant chemotherapy. Researchers will use drug Benmelstobart in combination with antiangiogenesis drugs and newadjuvant chemotherapy to see if the drug works to treat locally advanced gastric cancer / gastroesophageal junction cancer. Participants will:injection drug Benmelstobart，On the first day of each cycle, 3 weeks (21 days) were a treatment cycle.
Detailed description
The phase i/ii clinical study of benmelstobart combined with anlotinib, oxaliplatin and capecitabine in the first-line treatment of gastric / gastroesophageal junction adenocarcinoma has shown good efficacy and safety. Anti vascular drugs have also shown excellent anti-tumor effects in the neoadjuvant treatment of locally advanced gastric cancer. Therefore, this study plans to explore the efficacy of benmelstobart combined with anti angiogenic drugs and neoadjuvant chemotherapy for locally advanced gastric cancer / gastroesophageal junction cancer, and make up for this part of the treatment gap.
Interventions
PROCEDUREsurgery
After receiving the corresponding neoadjuvant treatment for 2 cycles, surgery was performed within 3-6 weeks after drug withdrawal.
DRUGBenmelstobart
1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of each cycle, 3 weeks (21 days) as a treatment cycle
DRUGtegafur
it needs to be administered according to the patient's body surface area< 40mg / time at 1.25m2; > 50mg/ time for 1.25m2 and <1.5m2; > 60mg/ time at 1.5m2; Oral, twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days, as a treatment cycle; Repeat every 3 weeks;
DRUGoxaliplatin
130mg/m2, administered on the first day of each cycle, repeated every 3 weeks;
DRUGalbumin paclitaxel
260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered on the first and eighth days of each cycle
Sponsors
Xijing 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
* 1.18 ≤ 70 years old, male or female; * 2\. ECoG score 0-1; * 3\. patients with locally advanced gastric cancer / gastroesophageal junction cancer confirmed by pathology (histology or cytology) (according to the WHO classification in 2015); * 4\. according to the eighth edition of clinical tumor TNM staging, patients with t3\ 4n+m0 gastric cancer / gastroesophageal junction cancer confirmed to be resectable or potentially resectable by endoscopic ultrasound and enhanced CT; * 5\. have measurable lesions (according to RECIST 1.1 standard, the long diameter of CT scan of tumor lesions is ≥ 10mm, and the short diameter of CT scan of lymph node lesions is ≥ 15mm;), and the tumor is > 2cm directly; * 6\. patients who were initially diagnosed with gastric cancer / gastroesophageal junction cancer without radiotherapy, chemotherapy, surgery and targeted therapy before enrollment; * 7\. if the main organ function is normal, it meets the following criteria: 1. Blood routine examination must meet the following requirements (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days): 1. ANC ≥ 1.5 × 109/l; 2. PLT ≥ 100 × 109/l; 3. HB ≥ 90 g/L； 2. Biochemical tests must meet the following criteria: 1. TBIL ≤ 1.5 × ULN; 2. Alt, AST ≤ 2.5 × ULN 3. Serum creatinine SCR ≤ 1.5 × ULN, endogenous creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula); 3. Coagulation function must meet: INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN; * 8\. patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 450ms (male), QTc ≥ 470ms (female)) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); * 9\. female subjects of childbearing age must have a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraceptive measure (such as IUD, contraceptive or condom) during the study period and within 3 months after the last administration of study medication; For male subjects whose partner is a female of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study and within 3 months after the last study administration; The subjects voluntarily joined the study and signed the informed consent form. -10.The compliance was good and they cooperated with the follow-up;
Exclusion criteria
* 1\.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | 2 years | Tumor tissue samples surgically removed after neoadjuvant therapy, without residual tumor cells |
Contacts
Primary ContactLiu Hong, master
Backup ContactFan Yi Wu
Outcome results
None listed