Advanced Gastric Cancer
Conditions
Interventions
Single-arm group:Xianjunfang Granules in combination with standard first-line Western medical regimen.
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years, gender. (2) Histologically confirmed as unresectable locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. (3) Any level of PD-L1 expression. (4) Meet the diagnostic criteria of spleen-kidney yang deficiency in traditional Chinese medicine; (5) At least 1 measurable or assessable lesion (according to iRECIST criteria); (6) ECOG performance status: 0-1. (7) No severe abnormalities in heart, lung, liver, or kidney function; (8) Patients receiving first-line treatment. If the patient has received adjuvant or neoadjuvant therapy, the disease recurrence must be at least 6 months after the last treatment; (9) Expected survival =3 months; (10) The investigator believes the patient can benefit from this treatment regimen.
Exclusion criteria
Exclusion criteria: (1) Patients with brain metastases presenting clinical symptoms; (2) Patients with other untreated or incurable malignant tumors; (3) Patients with HER2 (3+) by immunohistochemistry, or HER2 (2+) with FISH positivity; (4) Patients producing alpha-fetoprotein; (5) Patients with uncontrolled cardiac clinical symptoms or diseases, such as: a. NYHA class II or higher heart failure; b. Unstable angina; c. Myocardial infarction within the past year; d. Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; (6) Patients with multiple factors affecting oral drug absorption, such as inability to swallow or intestinal obstruction; (7) Patients who have undergone major surgery, open biopsy, or significant trauma within 28 days prior to enrollment; (8) Patients who are currently participating in or planning to participate in other clinical trials; (9) Other situations deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);1-year PFS rate; | — |
Countries
China
Contacts
Public ContactZhang Tong
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed