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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    50
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 17 July 2021

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.

Details
Condition Gastric Cancer Stage
Treatment apatinib, S1, nab paclitaxel, Sintilimab
Clinical Study IdentifierNCT04267549
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on17 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-70 years old
gastroscopy and pathology (histologically/cytologically ) confirmed local advanced or oligo-metastatic gastric adenocarcinoma
unresectable
m 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
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