Gastric CancerPhase 2NCT03957564
Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer
A Phase 2 study testing Neoadjuvant chemotherapy with PSOX regimen., Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma. and Detect the tumor related DNA in pathological tissues after operation. in people with Gastric Cancer and Gastro-oesophageal Junction Cancer, run by Affiliated Hospital of Qinghai University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Gastro-oesophageal Junction Cancer
- What is being tested?
- Neoadjuvant chemotherapy with PSOX regimen., Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma. and Detect the tumor related DNA in pathological tissues after operation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2019to 20 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiuda Zhao
Xining, Qinghai, 810000
Jiuda Zhao, +8613327661976, jiudazhao@126.com
About this study
Official title: Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Patients With Resectable or Locally Advanced Gastric or Gastro-oesophageal Junction Cancer
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.
Read the 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.
- Conditions
- Gastric Cancer, Gastro-oesophageal Junction Cancer
- Being tested
- 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.
- Keywords
- Gastric cancer, Gastro-oesophageal junction cancer, Neoadjuvant chemotherapy, Radical gastrectomy, Circulating tumor cells, Circulating tumor DNA, Circulating cell free DNA
- Medical subject headings
- Stomach Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapy with PSOX regimen.Drug
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.
Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma.Other
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.
Detect the tumor related DNA in pathological tissues after operation.Other
Detect the tumor related DNA in pathological tissues after operation.
Follow-up of DFS and OS in patients with gastric cancer after operation.Other
Follow-up of DFS and OS in patients with locally advanced or resectable gastric or gastro-oesophageal Junction cancer.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving neoadjuvant chemotherapy. | Experimental | 1. 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.
2. 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.
3. Explore the consistency between plasma ctDNA and tumor related DNA in pathological tissues after operation.
4. To explore the relationship between the dynamic changes of plasma CTC, ctDNA and cfDNA levels and the prognosis of patients after operation. Receives: Drug: Neoadjuvant chemotherapy with PSOX regimen.; Other: Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma.; Other: Detect the tumor related DNA in pathological tissues after operation.; Other: Follow-up of DFS and OS in patients with gastric cancer after operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Measured: 2 years
Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Measured: 2 years
Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.
Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.
Measured: 2 years
Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.
Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
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.
Measured: 2 years
Types of tumor-associated DNA in tumor tissues after operation.
Types of tumor-associated DNA in tumor tissues after operation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start28 May 2019
- Primary completion20 May 2022 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957564
- Sponsor's protocol ID
- AHQU-2019002
- Status last verified
- Jan 2020
- First submitted
- 7 May 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Patients With Resectable or Locally Advanced Gastric or Gastro-oesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT03957564
- Acronym / sponsor ID
- AHQU-2019002
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving neoadjuvant chemotherapy. | Experimental | Drug: Neoadjuvant chemotherapy with PSOX regimen., Other: Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma., Other: Detect the tumor related DNA in pathological tissues after operation., Other: Follow-up of DFS and OS in patients with gastric cancer after operation.1. 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. 2. 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. 3. Explore the consistency between plasma ctDNA and tumor related DNA in pathological tissues after operation. 4. To explore the relationship between the dynamic changes of plasma CTC, ctDNA and cfDNA levels and the prognosis of patients after operation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant chemotherapy with PSOX regimen.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. | Drug | Patients receiving neoadjuvant chemotherapy. |
| Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma.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. | Other | Patients receiving neoadjuvant chemotherapy. |
| Detect the tumor related DNA in pathological tissues after operation.Detect the tumor related DNA in pathological tissues after operation. | Other | Patients receiving neoadjuvant chemotherapy. |
| Follow-up of DFS and OS in patients with gastric cancer after operation.Follow-up of DFS and OS in patients with locally advanced or resectable gastric or gastro-oesophageal Junction cancer. | Other | Patients receiving neoadjuvant chemotherapy. |
Primary outcome
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Time frame: 2 years
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Time frame: 2 years
Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.
Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.
Time frame: 2 years
Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.
Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation.
3 secondary outcomes
Disease Free Survival(DFS)
Time frame: 2 years
Overall survival(OS)
Time frame: 2 years
Types of tumor-associated DNA in tumor tissues after operation.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant chemotherapy with PSOX regimen., Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma. and Detect the tumor related DNA in pathological tissues after operation. in people with Gastric Cancer and Gastro-oesophageal Junction Cancer, run by Affiliated Hospital of Qinghai University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation. (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.