Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer

  • End date
    May 20, 2024
  • participants needed
  • sponsor
    Affiliated Hospital of Qinghai University
Updated on 9 February 2022
mucinous adenocarcinoma
squamous cell carcinoma
neutrophil count
tumor cells
cancer chemotherapy
signet ring cell carcinoma


The purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment


  1. The baseline tests (sleeping tendency assessment, clinical symptom and cognitive assessments, clinical laboratory tests, genotyping, exploratory biomarker tests, etc.) are conducted to the schizophrenia patients before initiation of the clozapine dosing.
  2. On day 15 and 57, the changes from baseline clinical symptom and cognitive function are assessed after clozapine treatment. Also, the occurrence of adverse drug reactions are evaluated. In addition, blood sample collections are performed for the assessment of clozapine and its metabolite levels.

Condition Gastric Cancer, Gastro-oesophageal Junction Cancer
Treatment Neoadjuvant chemotherapy with PSOX regimen., Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma., Detect the tumor related DNA in pathological tissues after operation., Follow-up of DFS and OS in patients with gastric cancer after operation.
Clinical Study IdentifierNCT03957564
SponsorAffiliated Hospital of Qinghai University
Last Modified on9 February 2022


Yes No Not Sure

Inclusion Criteria

Patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer(>T1 and N+) without distant metastases (M0)
Pathological examination confirmed gastric or gastro-oesophageal junction cancer (adenocarcinoma, signet ring cell carcinoma, mucinous adenocarcinoma, squamous cell carcinoma, regardless of the degree of tissue differentiation)
Ambulatory males or females, age 18 years
Karnofsky Performance Score (KPS) 70 or ECOG(Eastern Cooperative Oncology Group) performance status: 0 or 1
Patients who can tolerate PSOX neoadjuvant chemotherapy
Planning to undergo radical gastrectomy after neoadjuvant chemotherapy
With cancer lesions that can be measured according to RECIST 1.1 criteria
No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
Adequate organ function as defined below: Hemoglobin 9 g/dl, Absolute neutrophil count(ANC 1.5109/L, Platelets 100109/L, Alkaline phosphatase( ALP) 2.5ULN,Total bilirubinTBIL 1.5ULN(upper limit of normal), Renal Serum Creatinine < 1.5 ULN, Serum Albumin 30g/l

Exclusion Criteria

Female in pregnancy or lactation, or refuse to receive contraception measures during chemotherapy
With distant metastasis or peritoneal dissemination diagnosed by CT/EUS(endoscopic ultrasonography)
Underwent prior antitumor treatment, including chemotherapy, radiotherapy, immune therapy or target therapy
Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease or condition that would make the subject inappropriate for study participation
Clinically serious cardiac disease or pulmonary dysfunction
Refuse to provide blood/tissue sample
Other situation to be judged not adaptive to the study by investigators
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