Back to resultsLiquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer
Primary Purpose
Gastric Cancer, Gastro-oesophageal Junction Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
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.
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Gastro-oesophageal junction cancer, Neoadjuvant chemotherapy, Radical gastrectomy, Circulating tumor cells, Circulating tumor DNA, Circulating cell free DNA
Eligibility Criteria
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） ≥ 1.5×109/L, Platelets ≥ 100*109/L, Alkaline phosphatase( ALP) ≤ 2.5×ULN,Total bilirubin（TBIL）≤ 1.5×ULN(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.
Sites / Locations
- Jiuda ZhaoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients receiving neoadjuvant chemotherapy.
Arm Description
Compare the monitoring of CTC, ctDNA and cfDNA with the results of CT scan and the blood level of CEA ,CA19-9 and CA72-4 tumor markers to explore the clinical value of dynamic detection of CTC, ctDNA and cfDNA in neoadjuvant chemotherapy and operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. Explore the clinical value of different types of CTC in neoadjuvant chemotherapy and Operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. CTC can be classified into three types: epithelial CTC, mesenchymal CTC, hybrids CTC. Explore the consistency between plasma ctDNA and tumor related DNA in pathological tissues after operation. To explore the relationship between the dynamic changes of plasma CTC, ctDNA and cfDNA levels and the prognosis of patients after operation.
Outcomes
Primary Outcome Measures
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.
Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.
Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.
Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.
The relationship between tumor response and changes in numbers of CTC pre- and post-neoadjuvant chemotherapy and after operation.
The relationship between tumor response and changes in numbers of CTC pre- and post-neoadjuvant chemotherapy and after operation.
The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation.
The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation.
Secondary Outcome Measures
Disease Free Survival(DFS)
The relationship between CTC, ctDNA and cfDNA and DFS in patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer.
Overall survival(OS)
The relationship between CTC, ctDNA and cfDNA and OS in patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer.
Types of tumor-associated DNA in tumor tissues after operation.
Types of tumor-associated DNA in tumor tissues after operation.
Full Information
NCT ID
NCT03957564
First Posted
May 7, 2019
Last Updated
January 18, 2020
Sponsor
Affiliated Hospital of Qinghai University
1. Study Identification
Unique Protocol Identification Number
NCT03957564
Brief Title
Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer
Official Title
Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Patients With Resectable or Locally Advanced Gastric or Gastro-oesophageal Junction Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
May 20, 2022 (Anticipated)
Study Completion Date
May 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Qinghai University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To explore the clinical value of dynamic detection of circulating tumor cells(CTCs), circulating tumor DNA(ctDNA) and cell-free DNA(cfDNA) in neoadjuvant chemotherapy and operation of resectable or locally advanced gastric or gastro-oesophageal junction cancer.
Detailed Description
Gastric cancer(GC) is one of the common malignant tumors in world, with relatively high incident rate and mortality among the population. Neoadjuvant chemotherapy is often needed before operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. Neoadjuvant chemotherapy should be combined with platinum and fluorouracil, or paclitaxel should be added on the basis of platinum and fluorouracil. The efficacy of neoadjuvant chemotherapy for GC patients is usually evaluated by computer tomography(CT) scans with RECIST 1.1 criteria and the blood level of carcinoembryonic antigen(CEA),CA19-9 (carbohydrate antigen 19-9)and CA72-4(carbohydrate antigen 72-4) tumor markers.
CTC originating from solid tumors are related to hematogenous metastatic spread to distant sites. Therefore, CTC analysis has clinical relevance as a biomarker to noninvasively monitor cancer progression and guide therapy.Moreover, ctDNA is a part of cfDNA derived from apoptotic, necrotic or secreted DNA fragments of tumor cells, ctDNA contains the same genetic defects as the tumor DNA of its origin, such as point mutation and rearrangement. We speculate CTC, ctDNA and cfDNA are new biomarkers for tumor, which can guide neoadjuvant chemotherapy and surgical treatment for patients with locally advanced or resectable gastric or gastro-oesophageal junction cancer.
In this study, investigators will compare the clinical value of the dynamic detection of CTC, ctDNA and cfDNA with CEA ,CA19-9 and CA72-4 tumor markers and CT scan according the RECIST 1.1 criteria in neoadjuvant chemotherapy and operation for resectable or locally advanced gastric or gastro-oesophageal junction cancer. Investigators will also explore the relationship between the dynamic changes of CTC, ctDNA and cfDNA and the prognosis of patients after operation. The results will provide lots of meaningful information which may further improve the treatment of locally advanced or resectable gastric or gastro-oesophageal junction cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastro-oesophageal Junction Cancer
Keywords
Gastric cancer, Gastro-oesophageal junction cancer, Neoadjuvant chemotherapy, Radical gastrectomy, Circulating tumor cells, Circulating tumor DNA, Circulating cell free DNA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving neoadjuvant chemotherapy.
Arm Type
Experimental
Arm Description
Compare the monitoring of CTC, ctDNA and cfDNA with the results of CT scan and the blood level of CEA ,CA19-9 and CA72-4 tumor markers to explore the clinical value of dynamic detection of CTC, ctDNA and cfDNA in neoadjuvant chemotherapy and operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer.
Explore the clinical value of different types of CTC in neoadjuvant chemotherapy and Operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. CTC can be classified into three types: epithelial CTC, mesenchymal CTC, hybrids CTC.
Explore the consistency between plasma ctDNA and tumor related DNA in pathological tissues after operation.
To explore the relationship between the dynamic changes of plasma CTC, ctDNA and cfDNA levels and the prognosis of patients after operation.
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant chemotherapy with PSOX regimen.
Intervention Description
Resectable gastric or gastro-oesophageal junction cancer patients receiving neoadjuvant chemotherapy with PSOX（Paclitaxel+Oxaliplatin+S1）regimen.
The details are as follows:
Paclitaxel 135mg/m2 d1, Oxaliplatin 85mg/m2 d1, S1 40-60mg/m2 twice daily, d1-14 , 21 days is one cycle.
Intervention Type
Other
Intervention Name(s)
Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma.
Intervention Description
Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in 3 time points：Before neoadjuvant chemotherapy, After 2-3 cycles of neoadjuvant chemotherapy, 10 days after operation.
Intervention Type
Other
Intervention Name(s)
Detect the tumor related DNA in pathological tissues after operation.
Intervention Description
Detect the tumor related DNA in pathological tissues after operation.
Intervention Type
Other
Intervention Name(s)
Follow-up of DFS and OS in patients with gastric cancer after operation.
Intervention Description
Follow-up of DFS and OS in patients with locally advanced or resectable gastric or gastro-oesophageal Junction cancer.
Primary Outcome Measure Information:
Title
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Description
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Time Frame
2 years
Title
Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Description
Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Time Frame
2 years
Title
Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.
Description
Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.
Time Frame
2 years
Title
Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.
Description
Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.
Time Frame
2 years
Title
The relationship between tumor response and changes in numbers of CTC pre- and post-neoadjuvant chemotherapy and after operation.
Description
The relationship between tumor response and changes in numbers of CTC pre- and post-neoadjuvant chemotherapy and after operation.
Time Frame
2 years
Title
The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation.
Description
The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease Free Survival(DFS)
Description
The relationship between CTC, ctDNA and cfDNA and DFS in patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer.
Time Frame
2 years
Title
Overall survival(OS)
Description
The relationship between CTC, ctDNA and cfDNA and OS in patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer.
Time Frame
2 years
Title
Types of tumor-associated DNA in tumor tissues after operation.
Description
Types of tumor-associated DNA in tumor tissues after operation.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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） ≥ 1.5×109/L, Platelets ≥ 100*109/L, Alkaline phosphatase( ALP) ≤ 2.5×ULN,Total bilirubin（TBIL）≤ 1.5×ULN(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.
Facility Information:
Facility Name
Jiuda Zhao
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiuda Zhao
Phone
+8613327661976
Email
jiudazhao@126.com
12. IPD Sharing Statement
Learn more about this trial
Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer
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