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Clinical study of modified immune cells (NRC-NK) for the treatment of stage ? colorectal cancer

Clinical study of modified immune cells (NRC-NK) for the treatment of stage ? colorectal cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IID-17011603
Enrollment
Unknown
Registered
2017-06-09
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-06-12

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

Conditions

colorectal cancer

Interventions

Patient1:Received 1 x 10^7 / m^2 NRC-NK cells infusion on day 0, followed by a second 6 x 10^7 / m^2 NRC-NK cells infusion on day 7 and a third 3 x 10^8 / m^2 NRC -NK cells infusion on day 14
Patient1:6 x10^7/m2 NRC-NK cells,twice a week and 3 x10^8/m2 NRC-NK cells, twice a week, with one week between the two doses
Patient2:Accept 3 x 10 ^ 8 / m ^ 2 CAR-NK cell input twice a week for 3 weeks
Patient3:Accept 3 x 10 ^ 8 / m ^ 2 CAR-NK cell input twice a week for 3 weeks

Sponsors

the Third Affiliated Hospital, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old; 2. Histological or cytologically confirmed peritoneal metastasis of colorectal cancer, malignant ascites; 3. Expected life is greater than 90 days; 4. ECOG physical status score 0-1 or KPS score = 60 points; 5. Heart, liver and kidney function within the normal range or controllable range (heart function does not exceed 2, ALT and / or AST does not exceed the normal upper limit of 1.5 times, Cr does not exceed the normal upper limit); 6. With a single or intravenous blood intake sufficient venous access, and no other blood separation contraindications; 7. By MDT discussion without a definite basis to benefit from surgery; 8. Treatment by MDT No benefit from chemotherapy therapy (FOLFOX / FOFIRI regimen has been completed, or incomplete patient can not tolerate / reject further chemotherapy), chemotherapy has stopped 4 weeks before patient receiving NRC-NK cell immunotherapy; 9. Volunteer to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. With acute or chronic infections associated with blood diseases, cardiovascular disease, lung disease, liver disease, kidney disease, pancreatic disease, endocrine disease; 2. Immune deficiency, autoimmune diseases; 3. Have severe allergies; 4. Received cell therapy in the previous 3 months; 5. Received systemic steroid therapy; 6. Pregnant or lactating women; 7. Brain metastases; 8. After being informed of the program, do not want to enter the group or not in line with the medical ethics committee on the project resolution.

Design outcomes

Primary

MeasureTime frame
blood routine;Urine routine;Liver and kidney function;Electrocardiogram;weight;Physical status score;Ultra sound examination of ascites;CT;MRI;Survival period;Ultra sound examination of liver and gallbladder;Circulating tumor cells;Analysis of serum CEA levels;Blood cell phenotype analysis;Plasma cytokine detection;Ascites cell phenotype analysis;Ascites cytokine detection;

Countries

China

Contacts

Public ContactXu Xuehu

the Third Affiliated Hospital, Guangzhou Medical University

maxtiger@126.com+86 18928916669

Outcome results

None listed

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