Gastric cancer
Conditions
Interventions
treatment group:Sintilimab+ Docetaxel+ Oxaliplatin+ tegafur
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients had to meet all of the following criteria: 1. Able to understand and voluntarily sign written informed consent. 2. The age of 18 years old or more, men and women. 3. The histologic diagnosis of the stomach or gastroesophageal junction (GEJ) adenocarcinoma. 4. pMMR or MSS type. 5. Her2-negative: immunohistochemical of 0, 1 + 2 + and FISH/SICH without amplification; No amplification or NGS prompt ERBB2. 6. Initially unresectable locally advanced (cT3-4N+M0) gastric cancer (including the primary tumor with severe invasion, inability to properly separate from the surrounding normal tissue or surrounded by large blood vessels; Regional lymph node metastasis was fixed and fused into clusters. Or other conditions evaluated by MDT that were not initially resectable). Or stage IV gastric cancer with synchronous single distant metastasis (including single distant liver metastasis, ovarian metastasis, lung metastasis, para-aortic lymph node metastasis, retroperitoneal or cervical lymph node metastasis that can be included in a radiotherapy field, etc.). 7. Subjects were always not received for locally advanced or metastatic gastric or gastroesophageal junction systemic treatment of adenocarcinoma. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 9. Expected survival =3 months. 10. Good organ function: Blood routine (no blood transfusion or growth factor support was allowed within 7 days before the first dose) Absolute neutrophil count =1.5×109/L Platelet count =100×109/L Hemoglobin = 90g/L or = 5.6mmol/L Liver and kidney function Creatinine (Cr) or calculated serum creatinine clearance (CrCl) Cr=1.5×ULN or CrCl=50mL /min (Calculated according to Cockcroft-Gault formula) Albumin acuity 28 g/L (within 14 days before the first dose not allow albumin infusion) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN; For subjects with combined liver metastasis, = 5 x ULN Total bilirubin (TBIL) =1.5×ULN; For subjects with evidence of confirmed/suspected Gilbert syndrome, TBIL = 3× ULN 11. Women of childbearing age must confirm a negative serum pregnancy test within 7 days before the first dose of the study drug and agree to use effective contraception for the duration of the study drug and for 120 days after the last dose. In this scheme, women of childbearing age are defined as sexually mature women: 1) did not undergo hysterectomy or bilateral oophorectomy 2) a non-continuous 24 months of spontaneous amenorrhea (amenorrhea after cancer treatment does not exclude fertility) (i.e., having had a period at any time in the previous 24 consecutive months). 12. Male patients whose sexual partner was a woman of reproductive age had to agree to use an effective contraceptive method for the duration of study drug use and for 120 days after the last dose.
Exclusion criteria
Exclusion criteria: Patients who met the following criteria were not eligible for the study: 1. Other pathological types confirmed by histopathological examination, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma; 2. Patients with a history of gastrointestinal perforation or gastrointestinal fistula within 6 months before the first administration. Patients were allowed if the perforation or fistula had been treated, such as excision or repair, and the disease was recovered or resolved as judged by the investigator. 3. Active or documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). Inability to swallow, malabsorption syndromes, or uncontrolled nausea, vomiting, diarrhoea or other gastrointestinal disorders that seriously affect the administration and absorption of medicines; 4. The presence of active malignant tumors in the past 3 years, except for participating tumors and cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, localized prostate cancer, etc. 5. Require the system to treat 2 years before the start of the study treatment autoimmune disease, activity, or the judge may recur or plan to treat autoimmune diseases. Except for: A) skin diseases that do not require systemic treatment (e.g. vitiligo, alopecia, psoriasis or eczema); B) hypothyroidism due to autoimmune thyroiditis requiring only stable doses of hormone replacement therapy; C) only needs a stable dose of insulin replacement therapy of type 1 diabetes; D) childhood asthma has complete remission, adults without any intervention; E) The disease will not recur in the absence of an external trigger, as judged by the investigator. 6.Grade =2 peripheral nerve disease was defined according to NCI CTCAE v5.0. 7. The presence of known interstitial lung disease or noninfectious pneumonia that is currently symptomatic or previously required systemic glucocorticoid therapy may affect the evaluation or management of toxicity related to the study treatment, as determined by the investigator. ; Note: Physiologic doses of glucocorticoids (=10 mg per day of prednisone or equivalent) were allowed. 8. Active pulmonary tuberculosis is known to be present. Suspected of active tuberculosis of the subjects, need to check the chest X-ray and sputum and excluded by a clinical symptoms and signs; 9. Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or hepatitis C) within 2 weeks before the first dose; 10. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 11. Untreated subjects with active hepatitis B (HBsag-positive and HBV-DNA > 1000 copies /ml[200 IU/ml] or higher than the lower limit of detection) and, for those with hepatitis B, required to receive anti-HBV treatment for the duration of the study treatment; Active hepatitis C subjects (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection) 12. Known history of immunodeficiency or HIV positive; 13. Known active syphilis infection; 14. Is participating in another clinical study, unless it is an observational, noninterventional clinical study, or the follow-up period of an interventional study; 15. Subjects requiring systemic treatment with glucocorticoids (> 10mg/ day prednisone or equivalent) or other immunosuppressive drugs within 14 days prior to the first dose. Except for: A)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of conversion; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival;Event-free survival;Disease control rate;objective remission rate;AEs; | — |
Countries
China
Contacts
Public ContactLv jing
The Affiliated Hospital of Qingdao University
Outcome results
None listed