Gastric cancer
Conditions
Interventions
Cohort 3 (N = 10):Investigator-selected systemic anti-tumor therapy + PIPAC
Cohort 1:Investigator-selected systemic anti-tumor therapy + PIPAV
Cohort 2:Investigator-selected systemic anti-tumor therapy + PIPAV + PIPAC
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years, regardless of gender; 2. Histologically or pathologically confirmed gastric adenocarcinoma with peritoneal metastasis (confirmed by imaging findings, previous surgical pathology, or positive ascites/peritoneal fluid cytology), and assessed by the investigator as having peritoneal lesions that are (unresectable) with a PCI score > 6; 3. No contraindications for laparoscopic surgery; 4. ECOG performance status = 6 months; 6. No blood transfusion or treatment with hematopoietic stimulating factors within 14 days prior to screening, and meeting the following laboratory criteria:(1). Hematology: Absolute neutrophil count (ANC) >= 1.5 × 10^9L, platelets (PLT) >= 100 × 10^9/L, hemoglobin (Hb) >= 90 g/L;(2). Blood biochemistry: Total bilirubin (TBIL) = 50 mL/min (calculated using the Cockcroft-Gault formula, only required if creatinine > 1.5 × ULN);(7). Coagulation: Activated partial thromboplastin time (APTT), international normalized ratio (INR), or prothrombin time (PT) <= 1.5 × ULN. 7. Female patients of childbearing potential or male patients with partners of childbearing potential must use effective contraception throughout the treatment period and for 3 months after the last dose; 8. Voluntary participation in the clinical study, with full understanding and signed informed consent form (ICF);willingness to comply with and ability to complete all trial procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with gastrointestinal obstruction; 2. Subjects entirely dependent on parenteral nutrition; 3. Subjects with decompensated ascites; 4. Subjects with severe intra-abdominal infection (manifesting as peritonitis); 5. Subjects with extensive intra-abdominal adhesions; 6. Subjects undergoing simultaneous cytoreductive surgery and gastrointestinal resection and reconstruction; 7. Subjects with portal vein thrombosis; 8. Known allergy to any component of the VRT106 formulation (mannitol, human albumin, trehalose, etc.) or to chemotherapeutic agents; 9. Use of live attenuated vaccines within 4 weeks prior to the first dose of study drug, including but not limited to: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are killed virus vaccines and are permitted; 2.intranasal influenza vaccines are live attenuated and are not permitted; 10. Use of systemic glucocorticoids (prednisone > 10 mg/day or equivalent dose of similar drugs) or other immunosuppressive therapy within 1 week prior to the first dose of study drug, except for: (1). Use of topical, ocular, intra-articular, intranasal, or inhaled glucocorticoids;(2).Use of glucocorticoids for prophylactic treatment (e.g., prevention of contrast agent allergy). 11. Use of immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 14 days prior to the first dose of study drug; 12. Subjects with active autoimmune disease or a history of autoimmune disease that may relapse. However, subjects with the following conditions are not excluded and may be further screened: (1). Type 1 diabetes;(2). Hypothyroidism (controlled with hormone replacement therapy alone);(3). Controlled celiac disease;(4). Skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia);(5). Any other disease not expected to recur in the absence of external triggers; 13. History of splenectomy; 14. Previous anti-tumor treatment-related adverse events not resolved to = 480 ms, etc;(2).Acute coronary syndrome, acute myocardial infarction, congestive heart failure, stroke, or other Grade 3 or higher cardiovascular events within 6 months prior to the first dose of study drug;(3). New York Heart Association (NYHA) functional class = II, or left ventricular ejection fraction (LVEF) < 50%;(4).Poorly controlled hypertension as judged by the investigator (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg despite standard treatment); 16. Active infection requiring systemic therapy and not controlled; 17. Presence of other invasive malignancies besides the study disease, except for cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ (e.g., breast cancer, cervical carcinoma in situ), superficial bladder cancer, or any malignancy with no recurrence and no treatment within the past 2 years; 18. Pregnant or lactating women; 19. Subjects judged by the investigator to have other severe systemic diseases or other r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Indicators / Safety Endpoints(Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (graded by CTCAE Version 5.0));Safety Indicators / Safety Endpoints (Changes from baseline in physical examination findings, ECOG performance status, vital signs, laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, etc.), and 12-lead electrocardiogram (ECG));Safety Indicators / Safety Endpoints (Surgical complications;Postoperative pain scores (Visual Analog Scale, VAS)); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (QoL) Score;Biodistribution characteristics and biological effects (only for the first 5 subjects in Cohort 1);Efficacy Indicators(Progression-free survival,Object response rate,Disease control rate,Ascites response rate,Change in Peritoneal Cancer Index ,Negative conversion rate of ascites cancer cells);Efficacy Indicator (histological response rate assessed by peritoneal regression grading score, surgical conversion rate, 1-year survival rate); | — |
Countries
China
Contacts
Public ContactLi Yong
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed