Gastric Cancer
Conditions
Interventions
Group A:PD-1+chemotherapy+Huangqi granules
Group B:PD-1+chemotherapy
Sponsors
Beijing Friendshipi Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: [1] Age: 18 ~ 80 years old; [2] Pathologically confirmed advanced gastric cancer with measurable lesions (spiral CT >=10mm, measurable lesions without radiotherapy); There are qi deficiency syndrome, qi and blood deficiency disease [3] ECOG PS score: 0-1; [4] Predicted survival >=3 months; [5] can receive radiotherapy or surgery >=4 weeks, and the wound has healed completely; [6] Patients may have a history of brain/meningeal metastasis, but must have undergone local therapy (surgery/radiation) before randomization and be clinically stable for at least 2 months; [7] Normal function of major organs, that is, meeting the following criteria: (1) Blood routine: HB>=90g/L (no transfusion within 14 days); ANC >=1.5×10^9/L; PLT>=80×10^9/L; (2) BIL 50ml/min (Cockcroft-Gault formula); [8] Subjects voluntarily participated in this study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: [1] Pregnant or lactating women; [2] Patients with a known or suspected history of autoimmune disease. [3] Previous history of bone marrow, stem cells, or solid organ transplantation. [4] Received any systemic antitumor therapy or investigational therapy within 4 weeks prior to study drug administration, radiotherapy within 2 weeks prior to study drug administration, and corticosteroids (>=10mg/ day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to study drug administration. Topical, ocular, inhaled, or nasal steroid administration is permitted. Cardiovascular disease, lung damage, gastrointestinal disease of clinical significance. [5] Other malignancies were present or concomitant, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. [6] Patients who are allergic to astragalus and have contraindications to astragalus or immunotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;Qol;AE; | — |
Countries
China
Contacts
Public ContactJing Wang
Beijing Friendshipi Hospital, Capital Medical University
Outcome results
None listed