Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

To explore the efficacy and safety of Penpulimab combined with SOX in the perioperative treatment of gastric cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Central Hospital of Lishui City
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• signed and dated informed consent;

• At least 18 years of age;

• ECOG PS: 0-1;

• Patients with gastric cancer diagnosed as T3-4NXMX by imaging;

• Patients with gastric adenocarcinoma diagnosed by cytology;

• Patients with gastric cancer assessed by the surgeon as suitable for neoadjuvant therapy or conversion therapy followed by radical resection;

• Laboratory tests should meet the following requirements (28 days before enrollment in baseline period) :

• Women should agree that they must use contraception during and for 6 months after the study; Had a negative serum pregnancy test within 7 days prior to study enrollment and had to be non-lactating; Men should agree that they must use contraception during the study and for 6 months after the end of the study period.

Exclusion Criteria:

• Co-existing with other malignant tumors (except cured basal cell carcinoma of the skin);

• Gastric cancer patients with T1-2N0M0;

• Previous treatment including anti-PD-1 /PD-L1/CTLA-4 antibody therapy or other immunotherapy directed against PD-1/PD-L1/CTLA-4;

• Weight loss greater than or equal to 20% within 4 weeks before the first dose;

• Severe hypersensitivity after administration of other monoclonal antibodies;

• The presence or history of any active autoimmune disease

• Immunosuppressive therapy, systemic or absorbable local hormone therapy (dose > 10mg/ day prednisone or other effective hormone) is required to achieve immunosuppression and continues to be used within 2 weeks of the first administration;

• Patients with multiple factors affecting oral medication

• Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;

• Had received a prophylactic or attenuated vaccine within 4 weeks before the first dose;