A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer
This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer.
- EligibilityCriteria: Inclusion Criteria:  Male or female, age≥ 18 years； 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; Tumor Her2 negative (IHC 0/1＋ or IHC 2＋ and FISH-). At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors （RECIST) 1.1; WBC≥3.0×10^9 /L; ANC≥1.5×10^9 /L; HB≥90 g/L; PLT≥75×10^9 /L; 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) LVEF≥50%; male QTc≤450 mms, female QTc≤470 mms; ECOG 0~1； Expected survival ≥ 3 months; Consent to contraception； Understand and voluntarily sign a written ICF and be willing to comply with all trial requirements.  Exclusion Criteria:  History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration; Patients with central nervous system metastases with clinical symptoms; 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; Previous treatment with other adenovirus drugs within 28 days before the first dose of BioTTT001; Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 14 days before the first dose of BioTTT001; Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia ); Patients with primary immunodeficiency; 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); Patients with active infection requiring systemic anti-infective therapy; HBsAg positive, and blood HBV DNA≥100 IU/mL; anti-HCV positive; HIV positive; active syphilis; Patients with active tuberculosis or drug-induced interstitial lung disease； Patients with active inflammatory bowel disease ； NYHA≥ grade 3； Known allergy to the investigational drug or its components; Patients with prior organ transplants; Pregnant or lactating women; Other reasons judged by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult