Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) for Resectable Locally Advanced Gastric Cancer

Korábbi kezelés

• Current participation in an interventional clinical study or treatment with another investigational drug or use of an investigational device within 4 weeks prior to the first dose of study drug
• Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting CTLA-4, OX-40, CD137, etc.
• Diagnosis of a malignant disease other than gastric cancer within 5 years prior to the first dose of therapy
• Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose of the drug
• Live vaccination within 30 days prior to the first administration of the drug
• Have received systemic systemic therapy with proprietary Chinese medicines with antitumor indications or immunomodulatory drugs within 2 weeks prior to the first administration of the drug
• Have received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment
• Has not fully recovered from any intervention-induced toxicity and/or complications (excluding malaise or alopecia) prior to initiation of therapy
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation

Más betegség

• Endoscopically show signs of active bleeding from the lesion
• Known hypersensitivity to drugs used in this study
• Known history of HIV infection
• Untreated active hepatitis B
• Active HCV infection
• The presence of any serious or uncontrolled systemic disease

Egyéb

• Pregnant or lactating women
• Other factors that, in the judgment of the investigator, may affect the outcome of the study

• Signed written Informed Consent Form
• Male or female, age ≥ 18 years old
• Histologically confirmed gastric adenocarcinoma, diagnosed as locally progressive according to the AJCC 8th ed, cTNM diagnosis of cT3-4aN1-3M0 and resectable lesion as assessed by the investigator
• No prior systemic therapy such as surgery, radiotherapy, or immunotherapy for the disease at hand
• Consent to radical surgical treatment and no contraindications to surgery as determined by the surgeon
• ECOG PS: 0-1 score
• Expected survival > 6 months
• Adequate organ function, must meet the following laboratory specifications:
  • 8.1 Absolute neutrophil count (ANC) ≥ 1.0x10\^9/L; 8.2 Platelets ≥ 80x10\^9/L; 8.3 Hemoglobin > 7g/dL; 8.4 Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Total bilirubin > 1.5 x ULN but direct bilirubin ≤ ULN are allowed to be enrolled); 8.5 AST, ALT ≤ 2.5×ULN; 8.6 Blood creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 ml/min; 8.7 INR or PT ≤ 1.5 times ULN; 8.8 TSH within normal range (Enrollment allowed if baseline TSH is outside normal range but FT4 is within normal range); 8.9 Myocardial enzyme profile within normal range;
• Negative pregnancy test in women of childbearing age
• Need to use contraception with an annual failure rate of less than 1% if there is a risk of conception