Stomach NeoplasmsNCT04053725
Prediction of the Efficacy of ctDNA in Immunotherapy for Advanced Gastric Cancer
An observational study of Stomach Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial summary
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to Nov 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 to 80 years
- All sexes
- Adult, Older adult
Study population: This prospective clinical study program enrolled 80 patients. Patients should be treated with second- or third-line chemotherapy and combined with immunoassay inhibitors. The pre-treatment plasma ctDNA sample mutation information of each patient was compared with the tissue sample mutation information. The pre-treatment ctDNA dynamic monitoring results were compared with the ctDNA mutation information after treatment initiation. The post-treatment ctDNA dynamic monitoring results and imaging comparison analysis.
Who may be able to join
- Male or female ≥ 18 years of age at first visit.
- Patients must have histologically confirmed gastric cancer .
- Patients were surgically assessed to be inoperable.
- Patients received second-line or third-line chemotherapy and were treated with immunoassay point inhibitors.
- Patients' early pathological information was complete, including tumor site and pathological type.
- Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS analysis.
- Patients must be able to follow the study visit schedule and willing to provide peripheral blood samples at the indicated time point.
- Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.
Who cannot join
- Patients who cannot provide peripheral blood samples prior to the surgical treatment will be excluded.
- Patients with severe infection will be excluded.
- Patients with other serious disease besides gastric cancer will be excluded.
- Pregnant women will be excluded.
- Patients who are alcoholic or drug abusers will be excluded.
- Patients with a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, 510060
Rui-Hua Xu, MD, PhD, +862087342635, lvzd@sysucc.org.cn
Rui-hua Xu, MD, PhD
About this study
Official title: A Prospective Study of Blood Circulating Tumor DNA for the Prediction of Efficacy in Immunotherapy for Advanced Gastric Cancer.
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. The present clinical trial aims to explore the possibility of clinical utility of serum ctDNA as a clinical index to predict the efficacy in immunotherapy for advanced gastric cancer.
Read the detailed description
Gastric cancer is one of the most common malignant tumors in China, with the second highest incidence and the third highest mortality.Adenocarcinoma accounts for 95% of gastric malignancies and is the most common malignancy of the digestive tract. Seventy percent of the patients with early gastric cancer had no obvious symptoms, and a few had nausea, vomiting or ulcer-like upper gastrointestinal symptoms.
Surgical treatment is the first choice for the treatment of early gastric cancer, but postoperative recurrence and metastasis are prone to occur. At the same time, there are relatively few chemotherapy drugs for gastric cancer, only a few chemotherapy drugs of Paclitaxel and platinum drugs are selected, and the chemotherapy regimen is relatively single. Meanwhile, the prognosis of gastric cancer in different parts is significantly different, and its molecular heterogeneity is strong. Studies have shown that about 13% of gastric cancer has HER2 gene variation, and there is no other specific driver gene mutation except HER2. Currently, only two targeted drugs, trastuzumab and apatinib, are approved for the treatment of gastric cancer in China.
CtDNA is the body's endogenous tumor DNA free of cells in circulating blood. It is generally believed that ctDNA in the blood of tumor patients is mainly derived from tumor cell necrosis and proliferation after apoptosis, as well as the release of proliferative and active tumor cells. At present, most studies have proved that the DNA of tumor cells has consistent genetic changes with ctDNA, and the same genetic changes may be detected in the plasma free DNA of patients with driver gene mutations in the primary or metastatic lesions. Therefore, ctDNA is a characteristic tumor biomarker and can be qualitatively, quantitatively and dynamically tracked.
Immunoassay point inhibitors, including pd-1 inhibitors, pd-l1 inhibitors and ctla-4 inhibitors, have achieved significant efficacy in a variety of tumors and are expected to change the treatment status of tumors. In the case of gastric cancer, recently the Lancet Oncology published the final results and review of the KEYNOTE 012 study that investigated the efficacy of Pembrolizumab in patients with advanced pd-l1 positive gastric cancer. Results showed that 53% of patients had tumor regression, 22% had partial imaging remission, and the median duration of remission was 40 weeks. Pembrolizumab is also superior to standard second-line chemotherapy. However, currently there is no recognized indicator that can predict the efficacy of immunotherapy for gastric cancer, and relevant research is urgently needed.
The purpose of this study was to investigate the correlation between the dynamic changes of ctDNA during surgery and the effect of immunotherapy on gastric cancer patients and its effect as a hematological index for the prognosis of advanced gastric cancer. Meanwhile, molecular markers related to the prognosis of advanced gastric cancer were screened out by comparing the differences in the molecular characteristics of gastric cancer tissues among patients with different prognosis.
- Conditions
- Stomach Neoplasms
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportions of patients with positive serum ctDNA that have postoperative relapse
the proportions of patients with positive serum ctDNA (in any follow-up) that have postoperative relapse
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
The proportion of ctDNA content decreased in patients with good therapeutic effect
The proportion of patients with good therapeutic effect whose serum ctDNA content decreased (in any follow-up）
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Feb 2019
- Primary completionMay 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- Rui-hua Xu, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053725
- Sponsor's protocol ID
- SYSUCC-ctDNA
- Status last verified
- Sep 2019
- First submitted
- 16 Jun 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Blood Circulating Tumor DNA for the Prediction of Efficacy in Immunotherapy for Advanced Gastric Cancer.
- ClinicalTrials.gov ID
- NCT04053725
- Acronym / sponsor ID
- SYSUCC-ctDNA
- Conditions
- Stomach Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 12 Aug 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.
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. The present clinical trial aims to explore the possibility of clinical utility of serum ctDNA as a clinical index to predict the efficacy in immunotherapy for advanced gastric cancer.
Detailed description
Gastric cancer is one of the most common malignant tumors in China, with the second highest incidence and the third highest mortality.Adenocarcinoma accounts for 95% of gastric malignancies and is the most common malignancy of the digestive tract. Seventy percent of the patients with early gastric cancer had no obvious symptoms, and a few had nausea, vomiting or ulcer-like upper gastrointestinal symptoms.
Surgical treatment is the first choice for the treatment of early gastric cancer, but postoperative recurrence and metastasis are prone to occur. At the same time, there are relatively few chemotherapy drugs for gastric cancer, only a few chemotherapy drugs of Paclitaxel and platinum drugs are selected, and the chemotherapy regimen is relatively single. Meanwhile, the prognosis of gastric cancer in different parts is significantly different, and its molecular heterogeneity is strong. Studies have shown that about 13% of gastric cancer has HER2 gene variation, and there is no other specific driver gene mutation except HER2. Currently, only two targeted drugs, trastuzumab and apatinib, are approved for the treatment of gastric cancer in China.
CtDNA is the body's endogenous tumor DNA free of cells in circulating blood. It is generally believed that ctDNA in the blood of tumor patients is mainly derived from tumor cell necrosis and proliferation after apoptosis, as well as the release of proliferative and active tumor cells. At present, most studies have proved that the DNA of tumor cells has consistent genetic changes with ctDNA, and the same genetic changes may be detected in the plasma free DNA of patients with driver gene mutations in the primary or metastatic lesions. Therefore, ctDNA is a characteristic tumor biomarker and can be qualitatively, quantitatively and dynamically tracked.
Immunoassay point inhibitors, including pd-1 inhibitors, pd-l1 inhibitors and ctla-4 inhibitors, have achieved significant efficacy in a variety of tumors and are expected to change the treatment status of tumors. In the case of gastric cancer, recently the Lancet Oncology published the final results and review of the KEYNOTE 012 study that investigated the efficacy of Pembrolizumab in patients with advanced pd-l1 positive gastric cancer. Results showed that 53% of patients had tumor regression, 22% had partial imaging remission, and the median duration of remission was 40 weeks. Pembrolizumab is also superior to standard second-line chemotherapy. However, currently there is no recognized indicator that can predict the efficacy of immunotherapy for gastric cancer, and relevant research is urgently needed.
The purpose of this study was to investigate the correlation between the dynamic changes of ctDNA during surgery and the effect of immunotherapy on gastric cancer patients and its effect as a hematological index for the prognosis of advanced gastric cancer. Meanwhile, molecular markers related to the prognosis of advanced gastric cancer were screened out by comparing the differences in the molecular characteristics of gastric cancer tissues among patients with different prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This prospective clinical study program enrolled 80 patients. Patients should be treated with second- or third-line chemotherapy and combined with immunoassay inhibitors. The pre-treatment plasma ctDNA sample mutation information of each patient was compared with the tissue sample mutation information. The pre-treatment ctDNA dynamic monitoring results were compared with the ctDNA mutation information after treatment initiation. The post-treatment ctDNA dynamic monitoring results and imaging comparison analysis.
Key inclusion criteria (8 listed)
- Male or female ≥ 18 years of age at first visit.
- Patients must have histologically confirmed gastric cancer .
- Patients were surgically assessed to be inoperable.
- Patients received second-line or third-line chemotherapy and were treated with immunoassay point inhibitors.
- Patients' early pathological information was complete, including tumor site and pathological type.
Key exclusion criteria (6 listed)
- Patients who cannot provide peripheral blood samples prior to the surgical treatment will be excluded.
- Patients with severe infection will be excluded.
- Patients with other serious disease besides gastric cancer will be excluded.
- Pregnant women will be excluded.
- Patients who are alcoholic or drug abusers will be excluded.
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 proportions of patients with positive serum ctDNA that have postoperative relapse
Time frame: through study completion, an average of 2 years
the proportions of patients with positive serum ctDNA (in any follow-up) that have postoperative relapse
1 secondary outcome
The proportion of ctDNA content decreased in patients with good therapeutic effect
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Rui-hua Xu principal investigator
Sun Yat-sen University
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 Stomach Neoplasms, run by Sun Yat-sen 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 8 inclusion and 6 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 9 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongsheng Zhang, MD.,PhD. (86-2087343804, Zhangdsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportions of patients with positive serum ctDNA that have postoperative relapse (time frame: through study completion, an average of 2 years). 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 Sep 2019.