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Clinical study on the safety and efficacy of umbilical cord blood mononuclear cells (UCB-MNCs) combined with neoadjuvant chemotherapy in patients with gastric cancer

Clinical study on the safety and efficacy of umbilical cord blood mononuclear cells (UCB-MNCs) combined with neoadjuvant chemotherapy in patients with gastric cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035355
Enrollment
Unknown
Registered
2020-08-09
Start date
2020-08-10
Completion date
Unknown
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Experimental Group:Cord blood mononuclear cells intravenous infusion
Control Group:Chemotherapy

Sponsors

Shandong Tumor Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years, both male and female; 2. The patients with gastric cancer confirmed by histopathology were in stage III according to TNM stage; 3. The patients who had not received anti-tumor treatment before admission and had no contraindications for chemotherapy and surgery; 4. ECoG: 0-1; 5. Patients with Karnofsky (KPS) score >=60; 6. All patients were expected to survive for more than 3 months; 7. The laboratory tests met the following criteria: Important organs (heart, lung, liver, kidney, etc.) function well; Pre meal blood glucose <=7mmol/L; 8. Women of childbearing age should take effective contraceptive measures; 9. Patients or their legal representatives voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who underwent major surgery within 4 weeks before enrollment, or whose surgical wounds have not yet healed; 2. In the past 5 years, he had malignant tumor of other histological origin; 3. Pregnant or lactating patients; 4. Patients with severe cardiovascular diseases, including hypertension (BP >=160 / 95mmhg), unstable angina pectoris, history of myocardial infarction in the past 6 months, congestive heart failure > NYHA class II, severe arrhythmia and pericardial effusion; 5. Patients with severe infection requiring intravenous antibiotic, antifungal or antiviral therapy; 6. Patients with mental illness and poor compliance; 7. Patients with bleeding >=CTCAE grade 3 within 4 weeks before enrollment; 8. Cases considered unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Objective mitigation rate (ORR);Disease control rate (DCR);

Countries

China

Contacts

Public ContactChai Jie

Shandong Tumor Hospital and Institute

chaijie3@126.com+86 18678867800

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026