Dendritic Cell-based Immunotherapy in Treatment Gastric Cancer

Phase 2

• Conditions: Gastric Cancer
• Interventions: Biological: activated DCs; Procedure: radical surgery only

• Registration Number: NCT03410732
• Lead Sponsor: LanZhou University

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.

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2018-01
• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-24
• Last Update Submitted: 2018-01-24
• Study First Posted: 2018-01-25
• Last Update Posted: 2018-01-25
• Primary Completion: 2020-07-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radical surgery plus activated DCs	activated DCs	In 21 days after a radical surgery, activated DCs are iv infused
Radical surgery only	radical surgery only	Radical surgery only group as a control group
Radical surgery plus activated DCs	radical surgery only	In 21 days after a radical surgery, activated DCs are iv infused

Primary Outcome Measures

Name	Time	Method
progression-free survival	3 years	Time to progression/death or censored time

Secondary Outcome Measures

Name	Time	Method
overall survival rate	5 years	time to death or censored time
immune-cells response	3 months	CD4/CD8 T lymphocyte percentage change
Adverse event rate	3 months	Adverse event rate
recurrent rate	3 years	the rate of cancer recurring after surgery

Trial Locations

Locations (1)

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China