Gastric CancerMENCA-GCNCT03425058
Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Gastric cancer (GC) is a leading global health problem and is the third most common cause of cancer related death. Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is the mainstay treatment for locally advanced gastric cancer, and variable degrees of tumor regression are observed after nCRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2017to 1 Oct 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: locally advanced gastric cancer patients without distant metastasis or peritoneal dissemination defined as cTNM stage of T4a/T4bN+M0
Who may be able to join
- Ambulatory males or females, age ≥ 18 years
- Karnofsky Performance Score (KPS) ≥70% or ECOG performance status: 0 or 1
- Pathologically confirmed gastric adenocarcinoma (regardless of degree of histologic differentiation) or adenocarcinoma with signet-ring cell carcinoma , mucinous adenocarcinoma
- Clinical Preoperative Stage cT4a/T4bN+M0 disease, including T4b、Bulky-N2, confirmed by CT/EUS
- Adequate organ function as defined below: Hemoglobin ≥ 9 g/dl, Hematologic Absolute Neutrophil Count （ANC） ≥ 1.5*109/L, Platelets ≥ 100*109/L, Aspartate Aminotransferase（AST） and Alanine Aminotransferase(ALT)≤ 2.5×ULN, Alkaline pPosphatase( ALP) ≤ 2.5×ULN, Total Bilirubin （TBIL）≤ 1.5×ULN, Renal Serum Creatinine < 1.5 ULN, Serum Albumin ≥ 30g/l.
- No serious concomitant disease that make survival period < 5 years
Show all 13Show fewer
- No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
- Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
- No mechanical obstruction.
- Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women
- Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
- Subjects has to voluntarily join the study and sign the Informed Consent Form for the study
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
- 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 or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)
- Clinically serious cardiac disease or pulmonary dysfunction.
- Patients require emergency surgery with complications (bleeding, perforation and obstruction) caused by gastric cancer
Show all 15Show fewer
- Other complications that cause no radical resection
- Serious concomitant disease that make survival period < 5 years
- No detection of CTCs or ctDNA in peripheral blood samples before NCT be enrolled in other clinical trials
- Allergic reaction to S-1 or oxaliplatin
- Abnormal GI tract function
- Refuse to provide blood/tissue sample
- Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
- Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons.
- Other situation to be judged not adaptive to the study by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Gastric cancer (GC) is a leading global health problem and is the third most common cause of cancer related death. Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is the mainstay treatment for locally advanced gastric cancer, and variable degrees of tumor regression are observed after nCRT. Treatment strategies, including close surveillance without immediate surgery, have been investigated to spare patients with complete tumor regression from potentially adverse outcomes of radical surgery. However, clinical and radiological assessment of treatment response does not deliver an ideal accuracy of patients identification with complete response. In the present study, we focused on the clinical courses of patients who have developed locally advanced gastric cancer, and investigated the potential clinical utility of the detection of deficient MMR(dMMR), microsatellite instability(MSI) status and the decreasing level of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) as promising biomarkers for the diagnosis and prediction of GC during treatment progress. Twenty milliliters of plasma were collected at 3 time points: before nCRT; after 2 cycles of nCRT; and after surgery. Firefly ctDNA NGS assays were used to track ctDNA mutations previously characterized in paired tumor tissue by massively parallel sequencing (MPS). We investigated whether circulating tumor DNA (ctDNA) detection can reflect tumor response to nCRT and detect minimal residual disease(MRD) after surgery. We compared CTC and ctDNA levels to clinical, radiological and pathological assessment modalities for nCRT response. The results will provide lots of information which may contribute to promote the treatment of GC patients. We want to introduce these strategies into clinical practice if possible.
Read the detailed description
This study is a single-center observational study on a patient cohort of at least 80 patients with histologically-confirmed locally advanced gastric cancer (LAGC). The protocol used in this study is approved by the Ethics Committee of Beijing Cancer Hospital.
The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.
Currently, the best treatment for early and mid-stage LAGC patients is resection but even with successful treatment, most patients still relapse and the 5-year survival rate is less than 30%.
For patients with cT4a/T4bN+M0, including T4b、Bulky-N2, primary lesions are not always fully excised during treatment and prognosis for these patients is generally poor. Recent studies, however, have suggested that the inclusion of neoadjuvant chemotherapy (NCT) can improve patient outcomes by: 1) downstaging tumors and increasing the likelihood of curative resection, 2) reducing the prevalence of micro metastases.
Historically, Oxaliplatin and s-1 combination therapy has been shown to be well-tolerated in patients with recurrent or metastatic gastric cancer.
To best evaluate the treatment response of NCT, we plan to investigate the effect of new technologies and assays on the successful prediction of patient outcomes.
Circulating tumor DNA (ctDNA), fragmented DNA with an average size of 166 bp, is released by cancer cells into circulation. Circulating tumor cells (CTCs) are rare malignant cells detached from tumors which enter the bloodstream. Both these biomarkers can be used for prognosis and the dynamic monitoring of disease progression.
In the MAGIC trial, patients with tumor that are MSI-H or MMRD, had survival rates superior to those with MSS/MSI-L or MMRP tumors when treated with surgery alone.
We will combine dMMR/MSI status with the dynamic evaluation of CTCs and ctDNA using liquid biopsy technology to determine whether changes in tumor burden in response to NTC can identify potential treatment responders.
Sequential peripheral blood samples for CTCs and ctDNA analysis will be taken before and after NCT, as well as one week after surgery.
Tumor assessments will be performed after 2 cycles NCT based on RECIST v1.1 criteria using CT/MRI scan.
- Conditions
- Gastric Cancer
- Keywords
- Molecular Evaluation, Locally Advanced Gastric Cancer, Neoadjuvant Chemotherapy, ctDNA, CTC, dMMR/MSI
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between dMMR/MSI status and response to neoadjuvant chemotherapy
The relationship between dMMR/MSI status and response to neoadjuvant chemotherapy
Measured: November 22, 2017 to December 31, 2018
The concordance and accuracy of response evaluation results determined by ctDNA, CTCs compared with imaging and serum tumor biomarkers(CEA, CA19-9,CA72-4 et al)
The concordance and accuracy of response evaluation results determined by ctDNA, CTCs compared with imaging and serum tumor biomarkers(CEA, CA19-9,CA72-4 et al)
Measured: November 22, 2017 to December 31, 2018
Secondary outcomes (2)
Prognostic values of the CTCs,ctDNA and dMMR/MSI testing
Prognostic values of the CTCs,ctDNA and dMMR/MSI testing
Measured: November 22, 2017 to December 31, 2018
The concordance of mutations in tumor tissue and ctDNA
The concordance of mutations in tumor tissue and ctDNA
Measured: November 22, 2017 to December 31, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start22 Nov 2017
- Primary completion1 Feb 2020
- Study completion1 Oct 2021
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.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiafu Ji, Peking University Cancer Hospital & Institute
- Investigators
- Jiafu Ji, MD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425058
- Sponsor's protocol ID
- 2017YJZ38
- Acronym
- MENCA-GC
- Status last verified
- Aug 2022
- First submitted
- 1 Feb 2018
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT03425058
- Acronym / sponsor ID
- MENCA-GC / 2017YJZ38
- Conditions
- Gastric Cancer
- Keywords
- Molecular Evaluation, Locally Advanced Gastric Cancer, Neoadjuvant Chemotherapy, ctDNA, CTC, dMMR/MSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 7 Feb 2018 (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.
Gastric cancer (GC) is a leading global health problem and is the third most common cause of cancer related death. Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is the mainstay treatment for locally advanced gastric cancer, and variable degrees of tumor regression are observed after nCRT. Treatment strategies, including close surveillance without immediate surgery, have been investigated to spare patients with complete tumor regression from potentially adverse outcomes of radical surgery. However, clinical and radiological assessment of treatment response does not deliver an ideal accuracy of patients identification with complete response. In the present study, we focused on the clinical courses of patients who have developed locally advanced gastric cancer, and investigated the potential clinical utility of the detection of deficient MMR(dMMR), microsatellite instability(MSI) status and the decreasing level of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) as promising biomarkers for the diagnosis and prediction of GC during treatment progress. Twenty milliliters of plasma were collected at 3 time points: before nCRT; after 2 cycles of nCRT; and after surgery. Firefly ctDNA NGS assays were used to track ctDNA mutations previously characterized in paired tumor tissue by massively parallel sequencing (MPS). We investigated whether circulating tumor DNA (ctDNA) detection can reflect tumor response to nCRT and detect minimal residual disease(MRD) after surgery. We compared CTC and ctDNA levels to clinical, radiological and pathological assessment modalities for nCRT response. The results will provide lots of information which may contribute to promote the treatment of GC patients. We want to introduce these strategies into clinical practice if possible.
Detailed description
This study is a single-center observational study on a patient cohort of at least 80 patients with histologically-confirmed locally advanced gastric cancer (LAGC). The protocol used in this study is approved by the Ethics Committee of Beijing Cancer Hospital.
The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.
Currently, the best treatment for early and mid-stage LAGC patients is resection but even with successful treatment, most patients still relapse and the 5-year survival rate is less than 30%.
For patients with cT4a/T4bN+M0, including T4b、Bulky-N2, primary lesions are not always fully excised during treatment and prognosis for these patients is generally poor. Recent studies, however, have suggested that the inclusion of neoadjuvant chemotherapy (NCT) can improve patient outcomes by: 1) downstaging tumors and increasing the likelihood of curative resection, 2) reducing the prevalence of micro metastases.
Historically, Oxaliplatin and s-1 combination therapy has been shown to be well-tolerated in patients with recurrent or metastatic gastric cancer.
To best evaluate the treatment response of NCT, we plan to investigate the effect of new technologies and assays on the successful prediction of patient outcomes.
Circulating tumor DNA (ctDNA), fragmented DNA with an average size of 166 bp, is released by cancer cells into circulation. Circulating tumor cells (CTCs) are rare malignant cells detached from tumors which enter the bloodstream. Both these biomarkers can be used for prognosis and the dynamic monitoring of disease progression.
In the MAGIC trial, patients with tumor that are MSI-H or MMRD, had survival rates superior to those with MSS/MSI-L or MMRP tumors when treated with surgery alone.
We will combine dMMR/MSI status with the dynamic evaluation of CTCs and ctDNA using liquid biopsy technology to determine whether changes in tumor burden in response to NTC can identify potential treatment responders.
Sequential peripheral blood samples for CTCs and ctDNA analysis will be taken before and after NCT, as well as one week after surgery.
Tumor assessments will be performed after 2 cycles NCT based on RECIST v1.1 criteria using CT/MRI scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- locally advanced gastric cancer patients without distant metastasis or peritoneal dissemination defined as cTNM stage of T4a/T4bN+M0
Key inclusion criteria (13 listed)
- Ambulatory males or females, age ≥ 18 years
- Karnofsky Performance Score (KPS) ≥70% or ECOG performance status: 0 or 1
- Pathologically confirmed gastric adenocarcinoma (regardless of degree of histologic differentiation) or adenocarcinoma with signet-ring cell carcinoma , mucinous adenocarcinoma
- Clinical Preoperative Stage cT4a/T4bN+M0 disease, including T4b、Bulky-N2, confirmed by CT/EUS
- Adequate organ function as defined below: Hemoglobin ≥ 9 g/dl, Hematologic Absolute Neutrophil Count （ANC） ≥ 1.5*109/L, Platelets ≥ 100*109/L, Aspartate Aminotransferase（AST） and Alanine Aminotransferase(ALT)≤ 2.5×ULN, Alkaline pPosphatase( ALP) ≤ 2.5×ULN, Total Bilirubin （TBIL）≤ 1.5×ULN, Renal Serum Creatinine < 1.5 ULN, Serum Albumin ≥ 30g/l.
Key exclusion criteria (15 listed)
- Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy
- With distant metastasis or peritoneal dissemination diagnosed by CT/EUS
- 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 or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)
- 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.
Primary outcome
The relationship between dMMR/MSI status and response to neoadjuvant chemotherapy
Time frame: November 22, 2017 to December 31, 2018
The relationship between dMMR/MSI status and response to neoadjuvant chemotherapy
The concordance and accuracy of response evaluation results determined by ctDNA, CTCs compared with imaging and serum tumor biomarkers(CEA, CA19-9,CA72-4 et al)
Time frame: November 22, 2017 to December 31, 2018
The concordance and accuracy of response evaluation results determined by ctDNA, CTCs compared with imaging and serum tumor biomarkers(CEA, CA19-9,CA72-4 et al)
2 secondary outcomes
Prognostic values of the CTCs,ctDNA and dMMR/MSI testing
Time frame: November 22, 2017 to December 31, 2018
The concordance of mutations in tumor tissue and ctDNA
Time frame: November 22, 2017 to December 31, 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Jiafu Ji, MD study chair
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Peking University Cancer Hospital & Institute 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 13 inclusion and 15 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: finished, as of the sponsor's last update on 9 Aug 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between dMMR/MSI status and response to neoadjuvant chemotherapy (time frame: November 22, 2017 to December 31, 2018). The study lists 2 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 9 Aug 2022.