There is a single initial non-resectable factor - HER2 negative advanced gastric cancer
Conditions
Interventions
Trial Group:1. Huaier Granules: 1 sachet (20g) each time, 3 times daily, taken orally continuously until disease progression or surgery
2. Chemotherapy (CAPOX regimen): Capecitabine 1000 mg/m^2, orally, twice daily, from day 1 to day 14
Oxaliplatin 130 mg/m^2, intravenous infusion, on day 1, once every 3 weeks
3. Immunotherapy (PD-1 inhibitors): Nivolumab 360mg or Sintilimab 200mg or Tislelizumab 200mg, once every 3 weeks, chosen by the patient
4. After the completion of conversion therapy, eligible subjects will undergo radical gastrectomy for gastric cancer.
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 years and above and 75 years and below, Gender: Open to all genders; 2.Patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma who have been diagnosed through histological or cytological methods; 3.Having a single initial non-resectable factor. For example: peritoneal metastasis (P1), positive free cancer cells in the abdominal cavity (CY1), para-aortic lymph node metastasis, liver metastasis (with lesions = 2 weeks. 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 6.Expected survival time >= 6 months; 7.The main organ functions are basically normal (no blood transfusion, albumin infusion, recombinant human thrombopoietin or colony-stimulating factor treatment within 14 days before enrollment), the cardiac function is good, and there is no active infection. 8.No chemotherapy, no immunotherapy, no contraindications for Huai'er Granules treatment; 9.There is at least one evaluable lesion (according to the RECIST 1.1 standard); 10.Voluntary participation and signing of a written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Including the history of other malignant tumors, the patient has received potentially curative treatment and there is no evidence of the disease within 5 years. The cases of successful resection of skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ are excluded. 2.Patients with HER2-positive gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; 3.The following distant metastases, confirmed by imaging or pathological examination, include but are not limited to lung metastasis, bone metastasis, adrenal metastasis, central nervous system metastasis, leptomeningeal metastasis, spinal cord compression or leptomeningeal diseases, etc. 4.Borrmann Type IV; 5.Patients who are preparing for or have previously undergone organ or bone marrow transplantation; 6.Had previously or currently suffered from congenital or acquired immune deficiency diseases; 7.Had active or previously documented autoimmune diseases or inflammatory disorders, such as autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, pituitary inflammation, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc; 8.Had experienced myocardial infarction within 6 months prior to enrollment, or had uncontrolled arrhythmia (including QTc interval for males >= 450 ms, females >= 470 ms) (QTc interval calculated using the Fridericia formula); 9.Had NYHA classification grade III-IV cardiac insufficiency or had a cardiac ultrasound examination showing LVEF (left ventricular ejection fraction) 10 mg/day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to enrollment or during the study period. However, the following situations are allowed for enrollment: Patients without active autoimmune diseases, allowing patients to use topical or inhaled corticosteroids, or adrenal hormone replacement therapy with a dose <= 10 mg/day prednisone therapeutic dose; 14.Had any active infection requiring systemic anti-infective treatment within 14 days prior to enrollment; excluding those receiving prophylactic antibiotics (such as for prevention of urinary tract infections or chronic obstructive pulmonary disease); 15.Was receiving treatment for other clinical studies, or the time from the end of the previous clinical study treatment to the start of this study treatment was less than 14 days; 16.Had a known severe allergic history to any monoclonal antibody or excipients of the study drug; 17.Pregnant or lactating women, as well as fertile female or male patients who are unwilling or unable to take effective contraceptive measures. 18.Had conditions that might increase the risk of participating in the study and receiving study medication, or other severe, acute and chronic diseases, as judged by the investigator, and were not suitable for participating in clinical studies;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Removal rate of R0; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical safety;3-year Overall Survival Rate;3-year Recurrence-Free Survival Rate;Objective Response Rate;Quality of life; | — |
Countries
China
Contacts
Public ContactChen Xiaodong
Sichuan Cancer Hospital
Outcome results
None listed