Gastric CancerNCT04086888
Real World Study of Immune Checkpoint Inhibitors for Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Gastric cancer ranks as the fifth most common and the third most common cause of cancer deaths in the world. In spite of the progresses made in the diagnosis and treatment of gastric cancer in the past decades, the prognosis is still unsatisfied mainly due to recurrence and distant metastasis. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 170 participants
- Where
- 2 sitesChina
- Study dates
- 12 Dec 2016to 20 Jun 2020
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 170 patients with advanced gastric cancer were enrolled. Patients need to be treated with immunocheckpoint inhibitors or immunocheckpoint inhibitors in combination with chemotherapy. 10ml of edta-anticoagulant blood was collected before the first treatment of the enrolled patients, and the blood samples were gently reversed in the anticoagulant tube for several times to fully anticoagulate. The upper plasma and the lower blood cells were centrifuged at 1800g for 10 min within 4 hours, respectively, and stored at -80 ℃ for later use and provide 10-15 tumor tissue white sheets.
Who may be able to join
- age above 16, male or female.
- patients with gastric cancer confirmed by pathology through tumor biopsy or puncture tissue.
- the patient was assessed as untreatable by surgery.
- patients received first line, second-line or third-line chemotherapy and were treated with immunne checkpoint inhibitors.
- the patient had complete preliminary pathological information, tumor site, pathological type and other information.
- the patient must have adequate tumor tissue or 5-10 FFPE white tablets to provide; After treatment, patients were returned to the hospital for re-examination every 3 treatment cycles, and plasma and peripheral blood samples could be obtained during the whole process.
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- other indicators of the patients met the general clinical trial enrollment conditions.
- subjects read and fully understand the instructions to patients, and sign the informed consent.
- -
Who cannot join
- Patients who cannot provide peripheral blood samples prior treatment.
- 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
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Rui-Hua Xu, MD, PhD, +862087342635, xurh@sysucc.org.cn
Rui-hua Xu, MD, PhD
- Recruiting
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, 510060
Rui-hua Xu, +862087342635
Dong-liang Chen, MD, Ph.D
About this study
Gastric cancer ranks as the fifth most common and the third most common cause of cancer deaths in the world. In spite of the progresses made in the diagnosis and treatment of gastric cancer in the past decades, the prognosis is still unsatisfied mainly due to recurrence and distant metastasis. Surgical treatment is the first choice for the treatment of early gastric cancer, but it is prone to recurrence and metastasis after surgery. There are relatively few chemotherapy drugs for gastric cancer. Studies have shown that about 13% of gastric cancers have HER2 gene amplification, and there are no other known driver gene other than HER-2. At present, the targeted therapeutic drugs approved for gastric cancer in China are only trastuzumab and apatinib.
Immune checkpoint inhibitors, including PD-1 inhibitors, PD-L1 inhibitors and CTLA-4 inhibitors, have achieved significant therapeutic effects in a variety of tumors and are expected to alter the current state of treatment of tumors. In gastric cancer, the KEYNOTE-012 study demonstated the efficacy of Pembrolizumab in patients with PD-L1 positive advanced gastric cancer. The study showed that 53% of patients had tumor retraction, and 22% achieved partial imaging remission with a median duration of 40 weeks. At the same time, Pembrolizumab is also less toxic than standard second-line chemotherapy. However, Are the Immune checkpoint inhibitors should be used as single-drug or in combination with chemotherapy? Are the Immune checkpoint inhibitors should be used in the first-line or in the back-line? And which is the best combination therapy? For these issues, there is no conclusion yet.
This observational study included all patients with gastric cancer who used Immune checkpoint inhibitors in clinical practice, regardless of treatment lines and combination with different chemotherapy. Through follow-up observations, the aim of this study is to analyze the efficacy of Immune checkpoint inhibitors for gastric cancer in the real world, and to explore the differences in the efficacy of Immune checkpoint inhibitors in different stages of treatment, as well as the efficacy of different chemotherapy combinations, so as to provide clinical evidence for the use of immunotherapy for advanced gastric cancer.
- Conditions
- Gastric Cancer
- Keywords
- Immune checkpoint inhibitors
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
OS (overall survival)
the time from receiving the first dose of Immune checkpoint Inhibitors treatment to death or the end of the observation
Measured: through study completion, an average of 3 years
Secondary outcomes (1)
progression-free survival (PFS)
the time from receiving the first dose of Immune checkpoint Inhibitors treatment to progression of disease (PD) or death
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start12 Dec 2016
- Primary completion17 Dec 2019 (estimated)
- Study completion20 Jun 2020 (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.
- 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
- 170 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, MD, Ph.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086888
- Sponsor's protocol ID
- RWS-ICI-GC
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of Immune Checkpoint Inhibitors for Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT04086888
- Acronym / sponsor ID
- RWS-ICI-GC
- Conditions
- Gastric Cancer
- Keywords
- Immune checkpoint inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 17 Dec 2019 (estimated)
- Study completion
- 20 Jun 2020 (estimated)
- First posted
- 12 Sep 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 ranks as the fifth most common and the third most common cause of cancer deaths in the world. In spite of the progresses made in the diagnosis and treatment of gastric cancer in the past decades, the prognosis is still unsatisfied mainly due to recurrence and distant metastasis. Surgical treatment is the first choice for the treatment of early gastric cancer, but it is prone to recurrence and metastasis after surgery. There are relatively few chemotherapy drugs for gastric cancer. Studies have shown that about 13% of gastric cancers have HER2 gene amplification, and there are no other known driver gene other than HER-2. At present, the targeted therapeutic drugs approved for gastric cancer in China are only trastuzumab and apatinib.
Immune checkpoint inhibitors, including PD-1 inhibitors, PD-L1 inhibitors and CTLA-4 inhibitors, have achieved significant therapeutic effects in a variety of tumors and are expected to alter the current state of treatment of tumors. In gastric cancer, the KEYNOTE-012 study demonstated the efficacy of Pembrolizumab in patients with PD-L1 positive advanced gastric cancer. The study showed that 53% of patients had tumor retraction, and 22% achieved partial imaging remission with a median duration of 40 weeks. At the same time, Pembrolizumab is also less toxic than standard second-line chemotherapy. However, Are the Immune checkpoint inhibitors should be used as single-drug or in combination with chemotherapy? Are the Immune checkpoint inhibitors should be used in the first-line or in the back-line? And which is the best combination therapy? For these issues, there is no conclusion yet.
This observational study included all patients with gastric cancer who used Immune checkpoint inhibitors in clinical practice, regardless of treatment lines and combination with different chemotherapy. Through follow-up observations, the aim of this study is to analyze the efficacy of Immune checkpoint inhibitors for gastric cancer in the real world, and to explore the differences in the efficacy of Immune checkpoint inhibitors in different stages of treatment, as well as the efficacy of different chemotherapy combinations, so as to provide clinical evidence for the use of immunotherapy for advanced gastric cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 170 patients with advanced gastric cancer were enrolled. Patients need to be treated with immunocheckpoint inhibitors or immunocheckpoint inhibitors in combination with chemotherapy. 10ml of edta-anticoagulant blood was collected before the first treatment of the enrolled patients, and the blood samples were gently reversed in the anticoagulant tube for several times to fully anticoagulate. The upper plasma and the lower blood cells were centrifuged at 1800g for 10 min within 4 hours, respectively, and stored at -80 ℃ for later use and provide 10-15 tumor tissue white sheets.
Key inclusion criteria (9 listed)
- age above 16, male or female.
- patients with gastric cancer confirmed by pathology through tumor biopsy or puncture tissue.
- the patient was assessed as untreatable by surgery.
- patients received first line, second-line or third-line chemotherapy and were treated with immunne checkpoint inhibitors.
- the patient had complete preliminary pathological information, tumor site, pathological type and other information.
Key exclusion criteria (6 listed)
- Patients who cannot provide peripheral blood samples prior treatment.
- 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
OS (overall survival)
Time frame: through study completion, an average of 3 years
the time from receiving the first dose of Immune checkpoint Inhibitors treatment to death or the end of the observation
1 secondary outcome
progression-free survival (PFS)
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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, MD, Ph.D principal investigator
Sun Yat-sen University
2 sites 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 Sun Yat-sen University at 2 sites 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 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 12 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 2 sites 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 Dong-liang Chen, MD, Ph.D (86-20-87342297, chendl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (overall survival) (time frame: through study completion, an average of 3 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 12 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.