Gastric cancer
Conditions
Interventions
Locally advanced patients with immune combined chemotherapy group(Phase III):Phase 1 (PD-1 antibody combined with chemotherapy for 6-8 cycles): Selectable PD-1 antibodies include domestically marketed
b. PD-1 antibody with SOX regimen (Oxaliplatin 130 mg/m^2 on day 1 IV drip, Tegafur 40-60 mg/m^2 twice daily on days 1-14 orally)
c. PD-1 antibody with Docetaxel 60-100 mg/m2 on day 1 IV drip plus Tegafur 40-60 mg/m^2 twice daily on days 1-14 orally. Repeat every 21 days for a total of 6-8 cycles.
Phase 2 (PD-1 antibody combin
b. PD-1 antibody with Tegafur regimen (Tegafur 40-60 mg/m^2 twice daily on days 1-14 orally). Repeat every 21 days until 1 year post-surgery.
Locally advanced patients chemotherapy group(Phase III):Compared with the immunotherapy combined with chemotherapy group, only the use of the PD-1 antibody was removed.
Patients with metastatic immunotherapy combined with chemotherapy group(Stage IV):The choice of chemotherapy regimen follows the recommendations of the CSCO guidelines and clinical research data, with
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: For Stage III patients: 1. Patients voluntarily join this clinical study, understand the study procedures, and are able to sign the informed consent form in writing; 2. Age 18-80 years; 3. Pathologically confirmed Stage III gastric cancer or Stage III-IVA gastroesophageal junction cancer after surgery, according to AJCC 8th edition staging, with adenocarcinoma histology and immunohistochemistry PD-L1 CPS>=5; 4. Patients underwent D2 radical gastrectomy for gastric cancer; 5. ECOG PS score of 0-1, with adequate heart, liver, kidney, and bone marrow function to tolerate antitumor therapy, with no contraindications to chemotherapy or immunotherapy. For Stage IV patients: 1. Patients voluntarily join this clinical study, understand the study procedures, and are able to sign the informed consent form in writing; 2. Age 18-80 years; 3. Gastric or gastroesophageal junction adenocarcinoma confirmed by endoscopy, biopsy of metastatic lesions, or surgery, with immunohistochemistry PD-L1 CPS>=5; 4. Confirmed as metastatic cancer according to AJCC 8th edition staging, with imaging-evaluable distant metastatic lesions; 5. ECOG PS score of 0-1, with adequate heart, liver, kidney, and bone marrow function to tolerate antitumor therapy, with no contraindications to chemotherapy or immunotherapy.
Exclusion criteria
Exclusion criteria: For Stage III patients: 1. Patients who underwent palliative surgery or did not achieve D2 radical resection, or patients whose postoperative baseline examination revealed tumor burden; 2. Patients with any active, known, or suspected autoimmune diseases; 3. Patients with a history of allergy to immunosuppressants or currently using immunosuppressants that may affect the efficacy of PD-1 antibodies; 4. Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study; 5. Patients with incomplete medical records who cannot be assessed or followed up; 6. Other situations where the investigator believes the patient is not suitable to participate in this trial. For Stage IV patients: 1. Patients with no evaluable tumor burden, non-metastatic cancer, or non-adenocarcinoma pathological type; 2. Patients with any active, known, or suspected autoimmune diseases; 3. Patients with a history of allergy to immunosuppressants or currently using immunosuppressants that may affect the efficacy of PD-1 antibodies; 4. Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study; 5. Patients with incomplete medical records who cannot be assessed or followed up; 6. Patients who have previously received immunotherapy, targeted therapy, chemotherapy, or other medical anti-tumor treatments; palliative radiotherapy for metastatic lesions is allowed, but post-radiotherapy lesions cannot be used as target lesions; 7. Other situations where the investigator believes the patient is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival time;2-year DFS rate;1 year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| CTCs and ctDNA;Objective Response Rate;Disease control rate;No recurrence survival time; | — |
Countries
China
Contacts
Public ContactGu Kangsheng
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed