Gastric Cancer
Conditions
Brief summary
An exploratory study of pembrolizumab combined with anlotinib and chemotherapy in the perioperative treatment of locally advanced gastric cancer
Detailed description
Previous studies have shown that anti-vascular drugs have excellent anti-tumor effects in the neoadjuvant treatment of locally advanced gastric cancer. The purpose of this study was to evaluate the neoadjuvant treatment of locally advanced gastric cancer with Penpulimab combined with anlotinib and chemotherapy. pathological complete response rate, disease-free survival, objective response rate, R0 resection rate and safety. The subjects used in the study were patients with resectable or potentially resectable T3\ 4N+M0 gastric cancer who were confirmed by endoscopic ultrasonography and enhanced CT. The specific dosing schedule of Piamprimab combined with anlotinib and chemotherapy was adopted. After receiving the corresponding neoadjuvant therapy for 3 cycles, surgery should be performed within 3-6 weeks after drug withdrawal; it is recommended that patients be given corresponding Adjuvant therapy, the specific adjuvant therapy plan shall be formulated by the investigator according to the individual situation of the patient. The primary endpoint was pathological complete response rate, and secondary key indicators were disease-free survival, objective response rate, R0 resection rate, and safety.
Interventions
DRUGPenpulimab combination with anlotinib and chemotherapy
Penpulimab: fixed dose of 200 mg, administered on day 1 of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14 of each cycle, orally once a day, about half an hour before breakfast (the time of daily administration should be the same as possible), with warm water, every 3 weeks Repeat 1 time
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Penpulimab in combination with anlotinib and chemotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old ≤ age ≤ 70 years old, male or female; * ECOG score 0\ 1 points; * Patients with locally advanced gastric cancer (according to WHO 2015 classification) confirmed by pathology (histology or cytology); * According to the eighth edition of clinical tumor TNM staging, patients with T3\ 4N+M0 gastric cancer confirmed by endoscopic ultrasonography and enhanced CT examination as resectable or potentially resectable; * With measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is ≥10mm, and the short diameter of CT scan of lymph node lesions is ≥15mm;), tumor diameter \> 2cm; * Those who were diagnosed with gastric cancer for the first time before enrolling in the group and who have not undergone radiotherapy, chemotherapy, surgery and targeted therapy; 1. Major organ function is normal, that is, the following criteria are met: 2. Routine blood tests must meet (no blood transfusion, no hematopoietic factor and no drug correction within 14 days): 1. ANC ≥ 1.5×109/L； 2. PLT ≥ 100×109/L； 3. HB ≥ 90 g/L； 3. Biochemical tests must meet the following criteria: 1. TBIL≤1.5×ULN； 2. ALT、AST≤ 2.5×ULN 3. serum creatinines Cr≤1.5×ULN，endogenous creatinine clearance≥50 mL/min（Cockcroft-Gault formula）； * Coagulation function must meet the following criteria：INR≤1.5×ULN;APTT≤1.5×ULN； Patients with myocardial ischemia or myocardial infarction above grade 1, arrhythmia (including QTc≥450ms (male), QTc≥470ms (female)) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); * Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before starting the study drug, and be willing to use a medically-approved high-efficiency contraceptive during the study and within 3 months after the last dose of study drug ( Such as: intrauterine device, contraceptive pill or condom); for male subjects whose partner is a female of childbearing age, surgical sterilization, or agree to use an effective method during the study and within 3 months after the last study dose contraception; * The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;
Exclusion criteria
* Target disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response, pCR | 12months | Defined as tumor tissue specimens resected surgically after neoadjuvant therapy with no residual tumor cells. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major pathologic response, MPR | 12months | Defined as tumor specimens resected after neoadjuvant therapy with residual tumor cells ≤10% |
Contacts
Primary ContactLiu Hong
Backup ContactWei Zhou
Outcome results
None listed