Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. DCs are activated by the proteins from autologous tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective response, immune-cell response, recurrent rate after a radical surgery, progression-free survival and overall survival, and the safety endpoints include adverse events, laboratory tests, ECG, ECOG-PT, etc.
Study objectives are to investigate the efficacy and safety of activated autologous dendritic cells (DCs) in treatment of gastric cancer. The autologous DCs are collected and enriched from peripheral blood, and then are activated by the proteins from autologous tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective response, immune-cell response, recurrent rate after a radical surgery, progression-free survival and overall survival, and the safety endpoints include adverse events, laboratory tests, ECG, ECOG-PT, etc. All patients will be followed up for at least 2 years after treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical surgery plus activated DCs | Experimental | In 21 days after a radical surgery, activated DCs are iv infused |
|
| Radical surgery only | Active Comparator | Radical surgery only group as a control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated DCs | Biological | autologous dendritic cells are collected and enriched from 50 ml of peripheral blood, then activated by autologous tumor cell membrane proteins. Then the activated DCs are iv infused in 21 days after a radical surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | Time to progression/death or censored time | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| recurrent rate | the rate of cancer recurring after surgery | 3 years |
| overall survival rate | time to death or censored time | 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Non-healing wounds on any part of the body
Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to surgery, unless adequately treated and stable
Active uncontrolled bleeding or a known bleeding diathesis
Significant cardiovascular disease or condition, including:
Abnormal hematologic, renal or hepatic function as defined by the following criteria:
Any of the following within 2 weeks prior to surgery:
Any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the trial treatment
Any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with trial procedures or is unwilling or unable to comply with trial requirements at the discretion of the Investigator
Breast feeding, or plans by the patient (or the patient's partner) to become pregnant during treatment or within 4 months after the end of treatment
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yumin Li, MD, PhD | Contact | +8613893615421 | liym@lzu.edu.cn | |
| Gui Gao, MD, PhD | Contact | +86-931-8942281 | Scottgao1110@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yumin Li | Lanzhou University Second Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lanzhou University Second Hospital | Recruiting | Lanzhou | Gansu | 730030 | China |
we'll update the registration system. But final data will be summarized and published in a medical journal
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| radical surgery only | Procedure | Only radical surgery is given to the control group |
|
| immune-cells response | CD4/CD8 T lymphocyte percentage change | 3 months |
| Adverse event rate | Adverse event rate | 3 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |