| Eligibility |
Inclusion Criteria:
1. Male or female, age= 18 years;
2. Patients with a diagnosis of gastric cancer by histopathology or cytology, accompanied
by peritoneal metastasis, without systemic therapy, or for patients who have received
neoadjuvant/adjuvant chemotherapy before, the time from last treatment to disease
recurrence > 6 months;
3. Tumor Her2 negative (IHC 0/1+ or IHC 2+ and FISH-).
4. At least one measurable lesion according to the Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1;
5. WBC=3.0×10^9 /L; ANC=1.5×10^9 /L; HB=90 g/L; PLT=75×10^9 /L;
6. ALT and AST=3×ULN (=5×ULN with liver metastasis); ALB=20g/L; Cr=1.5×ULN or CCr>50
mL/min; TBIL=1.5×ULN; APTT=1.5×ULN and INR or PT=1.5×ULN (without anticoagulation
therapy)
7. LVEF=50%; male QTc=450 mms, female QTc=470 mms;
8. ECOG 0~1;
9. Expected survival = 3 months;
10. Consent to contraception;
11. Understand and voluntarily sign a written ICF and be willing to comply with all trial
requirements.
Exclusion Criteria:
1. History of other malignancies (except cured basal cell skin cancer, cervical carcinoma
in situ etc.) within 5 years before study drug administration;
2. Patients with central nervous system metastases with clinical symptoms;
3. Patients who have been treated with high-dose systemic corticosteroids (prednisone >
10 mg/day or equivalent doses) or other immunosuppressants within 2 weeks before the
first dose of BioTTT001;
4. Previous treatment with other adenovirus drugs within 28 days before the first dose of
BioTTT001;
5. Patients who have undergone any major surgery (except needle biopsy, etc.) or severe
trauma within 14 days before the first dose of BioTTT001;
6. Patients who have not recovered from the adverse reactions of previous treatments (the
treatment-related toxicity = grade 2, except for alopecia );
7. Patients with primary immunodeficiency;
8. Patients with active autoimmune diseases (such as systemic lupus erythematosus,
rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs
hormone replacement therapy, and skin diseases that do not need systemic treatment
(such as vitiligo, psoriasis or alopecia);
9. Patients with active infection requiring systemic anti-infective therapy;
10. HBsAg positive, and blood HBV DNA=100 IU/mL; anti-HCV positive; HIV positive; active
syphilis;
11. Patients with active tuberculosis or drug-induced interstitial lung disease;
12. Patients with active inflammatory bowel disease ;
13. NYHA= grade 3;
14. Known allergy to the investigational drug or its components;
15. Patients with prior organ transplants;
16. Pregnant or lactating women;
17. Other reasons judged by the investigator.
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