Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Unresectable Gastric Cancer

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study to evaluate the efficacy and safety of combination of sintilimab (PD-1 inhibitor) , apatinib and chemotherapy in unresectable advanced gastric cancer patients with oligo metastasis. This study was designed as single arm with fixed number of participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Albumin-Bound Paclitaxel; Apatinib; Paclitaxel

Criteria

Inclusion Criteria:

• 18-70 years old;

• gastroscopy and pathology (histologically/cytologically ) confirmed local advanced or oligo-metastatic gastric adenocarcinoma;

• unresectable;

• ≥3m life expectancy；

• must have at least 1 measurable lesion using RECIST v1.1 criteria；

• adequate organ function

• pregnant test negative of females of childbearing potential , and willing to use adequate contraception

• written Informed Consensus Form

Exclusion Criteria:

• prior use of any checkpoint inhibitor treatment, including with no limited to PD-1, programmed cell death ligand-1(PDL-1), CTLA4 etc;

• patients with central nervous system, lung, or bone metastasis;

• Her 2 positive with willing to use herceptin treatment;

• prior active autoimmune disease or history of autoimmune disease;

• patients with other malignant tumor

• clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) < 50%;

• not controlled hypertension;

• prior systemic treatment to metastatic disease；

• previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency;

• patients with or previous with serious hemorrhage ;

• active infection or an unexplained fever;

• objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.

• history of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis ;

• patients who may receive vaccination during study period;

• mental disorders history, or psychotropic drug abuse history;

• unable to orally administration;