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Real World Study of Immune Checkpoint Inhibitors for Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04086888
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

Brief 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. 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.

Condition or disease
Gastric Cancer

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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real World Study of Immune Checkpoint Inhibitors for Advanced Gastric Cancer
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : December 17, 2019
Estimated Study Completion Date : June 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: through study completion, an average of 3 years ]
    the time from receiving the first dose of Immune checkpoint Inhibitors treatment to progression of disease (PD) or death

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

  1. age above 16, male or female.
  2. patients with gastric cancer confirmed by pathology through tumor biopsy or puncture tissue.
  3. the patient was assessed as untreatable by surgery.
  4. patients received first line, second-line or third-line chemotherapy and were treated with immunne checkpoint inhibitors.
  5. the patient had complete preliminary pathological information, tumor site, pathological type and other information.
  6. 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.
  7. other indicators of the patients met the general clinical trial enrollment conditions.
  8. subjects read and fully understand the instructions to patients, and sign the informed consent.


Exclusion Criteria:

  1. Patients who cannot provide peripheral blood samples prior treatment.
  2. Patients with severe infection will be excluded.
  3. Patients with other serious disease besides gastric cancer will be excluded.
  4. Pregnant women will be excluded.
  5. Patients who are alcoholic or drug abusers will be excluded.
  6. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04086888

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Contact: Dong-liang Chen, MD, Ph.D 86-20-87342297
Contact: Zhida Lv, BS 86-2087343795

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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Rui-Hua Xu, MD, PhD    +862087342635   
Principal Investigator: Rui-hua Xu, MD, PhD         
Sub-Investigator: Dong-liang Chen, MD, PhD         
Sun Yat-sen University Cancer Center Recruiting
Guanzhou, Guangdong, China, 510060
Contact: Rui-hua Xu    +862087342635      
Sub-Investigator: Dong-liang Chen, MD, Ph.D         
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Rui-hua Xu, MD, Ph.D Sun Yat-sen University

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Responsible Party: Ruihua Xu, Professor, Sun Yat-sen University Identifier: NCT04086888     History of Changes
Other Study ID Numbers: RWS-ICI-GC
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruihua Xu, Sun Yat-sen University:
Immune checkpoint inhibitors
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases