Dendritic Cell-based Immunotherapy in Treatment Gastric Cancer

NCT ID: NCT03410732

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-12-01

Brief Summary

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.

Detailed Description

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radical surgery plus activated DCs

In 21 days after a radical surgery, activated DCs are iv infused

Group Type: EXPERIMENTAL

activated DCs

Intervention Type: 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.

radical surgery only

Intervention Type: PROCEDURE

Only radical surgery is given to the control group

Radical surgery only

Radical surgery only group as a control group

Group Type: ACTIVE_COMPARATOR

radical surgery only

Intervention Type: PROCEDURE

Only radical surgery is given to the control group

Interventions

activated DCs

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.

Intervention Type: BIOLOGICAL

radical surgery only

Only radical surgery is given to the control group

Intervention Type: PROCEDURE

Other Intervention Names

activated DCs by autologous tumor cell membrane proteins

Eligibility Criteria

Inclusion Criteria

1. Written informed consent given before any trial-specific procedure is initiated

2. Male or female, at least 18 years of age at the time of informed consent

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

4. Life expectancy >3 months assessed during Screening

5. Documented (histologically- or cytologically-proven) gastric cancer that is can be radially removed

Exclusion Criteria

1. Non-healing wounds on any part of the body

2. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to surgery, unless adequately treated and stable

3. Active uncontrolled bleeding or a known bleeding diathesis

4. Significant cardiovascular disease or condition, including:

1. Congestive heart failure currently requiring therapy

2. Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) functional criteria (25)

3. Need for antiarrhythmic medical therapy for a ventricular arrhythmia

4. Severe conduction disturbance (e.g., 3rd degree heart block)

5. Unstable angina pectoris (last episode at least 6 months prior to surgery)

6. Uncontrolled hypertension (per the Investigator's discretion)

7. Myocardial infarction within 6 months prior to C1/D1

5. Abnormal hematologic, renal or hepatic function as defined by the following criteria:

1. Absolute neutrophil count (ANC) <1.5 ×109/L (1500/mm3)

2. Hemoglobin ≤9 g/dL

3. Platelet count <75 ×109/L (75,000/mm3)

4. Serum creatinine >1.5 × upper limit of normal (ULN) for the institution

5. Aspartate aminotransferase (AST) >3.5 × ULN for the institution or AST >5 × ULN for the institution in case of known liver metastases

6. Alanine aminotransferase (ALT) >3.5 × ULN for the institution or ALT >5 × ULN for the institution in case of known liver metastases

7. Total bilirubin >1.5 × ULN for the institution

8. Prothrombin time as assessed by International Normalized Ratio (INR) >1.5 × ULN for the institution*

9. Partial thromboplastin time (PTT) >1.5 × ULN for the institution*

6. Any of the following within 2 weeks prior to surgery:

1. Any serious or uncontrolled infection

2. Any infection requiring parenteral antibiotics

3. Unexplained fever >38.0 °C

7. 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

8. 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

9. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: lead

Responsible Party

Gui Gao, Ph D, MD

MD, Ph D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yumin Li

Role: PRINCIPAL_INVESTIGATOR

Lanzhou University Second Hospital

Locations

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yumin Li, MD, PhD

Role: CONTACT

liym@lzu.edu.cn

+8613893615421

Gui Gao, MD, PhD

Role: CONTACT

Scottgao1110@gmail.com

+86-931-8942281

Facility Contacts

Yumin Li, MD, PhD

Role: primary

liym@lzu.edu.cn

+8613893615421

Other Identifiers

LAUDC 2017001

Identifier Type: -

Identifier Source: org_study_id