Immunotherapy Gastroesophageal Junction
Conditions
Brief summary
To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer
Interventions
DRUGTislelizumab
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 ,Q3W
DRUGAnlotinib
Participants will receive anlotinib,12mg, qd，d1-d14，Q3W
DRUGOxaliplatin
Participants will receive Oxaliplatin, 130mg/m2, iv, day 1 ,Q3W
DRUGTegafur
Participants will receive S-1 40-60mg/m2/c次，bid ，d1-d14，Q3W
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female and male patient ≥ 18 and ≤ 75 years. * Histologically confirmed, medically operable, resectable adenocarcinoma of the gastroesophageal junction (AEG, Siewert II-III)，uT3, uT4a, uT4b any N category, M0, or any T N+ M0 patient * ECOG≤1 * No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed. * Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). * Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells. * The expected survival time is more than 6 months. * Women of childbearing age shall be those who agree to use contraception (such as intrauterine devices, contraceptives or condoms) during the study and for 6 months after the end of the study; those who have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating; and men who agree to use contraception during the study and for 6 months after the end of the study. * Hematological, hepatic and renal function parameters adequate to allow surgical procedure and chemotherapy * Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
Exclusion criteria
* Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ). * Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed, if it was still positive after reexamination, gastroscopy was required. * Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137). * A history of immunodeficiency, including HIV testing positive. * Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing. * Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally. * HER2 positive is known. * Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | 4 weeks after surgery | Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response | 4 weeks after surgery | Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell |
| Objective Response Rate (ORR) | At the end of Cycle 3 (each cycle is 21 days) | Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor |
Countries
China
Contacts
Primary ContactYe Zai sheng, Doctor
Outcome results
None listed