The efficacy and safety of S-1, oxaliplatin, nanoliposomal irinotecan combined with sintilimab as first-line treatment in patients with advanced gastric cancer

The efficacy and safety of S-1, oxaliplatin, nanoliposomal irinotecan combined with sintilimab as first-line treatment in patients with advanced gastric cancer: a phase II study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085893

Enrollment

Unknown

Registered

2024-06-20

Start date

2024-06-20

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

SOXIRIs group:S-1, oxaliplatin, nanoliposomal irinotecan, sintilimab

SOXs group:S-1, oxaliplatin, sintilimab

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Understand and be willing to sign written informed consent and be able to follow research protocols for treatment. 2.Age =18 years. 3.HER-2 negative unresectable advanced, recurrent and metastatic advanced gastric cancer or esophageal gastric junction adenocarcinoma confirmed by histology or cytology. 4.According to RECIST version 1.1, there is at least one measurable lesion. 5.Patients with gastric cancer who have not undergone systematic treatment. (Allow 6 months after neoadjuvant/adjuvant therapy) 6.ECOG performance status of 0-2. 7.Predicted survival time = 3 months. 8.Adequate organ function, defined as follows: (Those who need to complete hematological and biochemical tests within 3 days before enrollment and meet the following conditions) a. Absolute neutrophil count (ANC) = 1.5 * 109/L b. Hemoglobin = 90g/dL c. Platelet count (PLT) = 90 * 109/L d. Total bilirubin<upper limit of normal value (ULN) e. Liver function index (AST&ALT) chemical examination<2.5 times upper limit of normal value (ULN) (AST and ALT in patients with liver metastasis = 5 x ULN) f. Serum creatinine (Cr) = 1.5 × ULN or creatinine clearance rate = 60 ml/min (calculated according to Cockrow Fault); 9.Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, childbearing age Women/men should take effective contraceptive measures.

Exclusion criteria

Exclusion criteria: 1.patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma. 2.Previous history of severe allergies to any monoclonal antibody. 3.Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment. 4.Active infection: such as HIV infection, chronic HBV/HCV in active phase. 5.There are serious accompanying diseases: clinically severe (i.e. active) heart disease, renal failure, liver failure, uncontrolled epilepsy, central nervous system disease or history of mental disorders, researchers have determined that there is massive bleeding peptic ulcer, intestinal paralysis, intestinal obstruction, etc; 6.Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., corticosteroids, immunosuppressants), replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency). 7.Received strong inhibitors or inducers of CYP3A4 and CYP2C8, or UGT1A1. 8.Prolonged chronic diarrhea. 9.Serious mental illness. 10.The researchers believe that there are other factors that are not suitable for the experiment.

Design outcomes

Primary

Measure	Time frame
ORR;	—

Secondary

Measure	Time frame
Disease Control Rate,DCR;Progression-free Survival,PFS;OS;Safety;	—

Countries

China

Contacts

Public ContactShu Zhang

Cancer Hospital Affiliated of Shandong First Medical University

zhangshu@csco.org.cn+86 176 5311 5539

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026