A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer

University of Chinese Academy Sciences

Status: Enrolling

Conditions: Unresectable Gastric Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05385809

IRB-2022-278

Details and patient eligibility

About

This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages: 18-75 Years (concluding 18 and 75 Years)
• Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma
• Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th)
• Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor);
• Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.)
• At least 1 measurable lesion by RECIST v1.1 criteria
• ECOG PS: 0-2
• Received sintilimab combined with chemotherapy(SOX or PS) at least 1 cycle

Exclusion criteria

• Known Her2 positive
• Patients with incomplete data or other factors affecting the judgment of efficacy and safety