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A clinical study of cord blood-derived NK cells against recurrence and metastasis in patients with stage IIC and IIIC colorectal cancer

A clinical study of cord blood-derived NK cells against recurrence and metastasis in patients with stage IIC and IIIC colorectal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049737
Enrollment
Unknown
Registered
2021-08-09
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

colon cancer

Interventions

Test group:Postoperative adjuvant chemotherapy plus infusion of NK cells derived from human umbilical cord blood
control group:Postoperative adjuvant chemotherapy

Sponsors

The Third Affiliated Hospital of Kunming Medical University (Yunnan Tumor Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old, both male and female; 2. The first diagnosis, without any anti-tumor treatment before surgery, was confirmed as colon adenocarcinoma by pathology after surgery, and the AJCC/UICC 8th edition was used to stage IIc-IIIc according to TNM; 3. No abnormality of heart, liver, kidney and coagulation function: total bilirubin (TIIAC) =1.5^9/L; platelet (PLT) count: >=10^9/L; hemoglobin (Hb) level >=90g/L; 5. ECOG score 0-1 points; 6. Those who have no intellectual or mental impairment, have normal language expression ability, have the ability to judge their own pain and general conditions, and can cooperatively evaluate the content of pain and quality of life; 7. Those who voluntarily participated in this study, signed the informed consent form, had good compliance, and agreed to follow up for 2 years.

Exclusion criteria

Exclusion criteria: 1. Have a history of organ transplantation, etc.; 2. Combined with other tumor subjects; 3. Subjects with active tuberculosis and other serious infectious diseases; 4. Patients who are allergic to albumin; 5. Subjects with a history of prescription drug abuse, illicit drug abuse, and alcohol abuse within 6 months before screening; 6. Abuse of alcohol or drugs; 7. Pregnancy or lactation; 8. Participated in other clinical studies within 3 months before screening; 9. Any situation that the investigator believes may lead to participation in the study not in the best interests of the subjects or may prevent, limit or confound the safety or efficacy assessment prescribed by the protocol.

Design outcomes

Primary

MeasureTime frame
Recurrence and metastasis rates;

Secondary

MeasureTime frame
Incidence of adverse events (AE) and serious adverse events (SAE);Immune function-related detecting;Tumor biomarkers (CEA);Evaluation of quality of life;

Countries

China

Contacts

Public ContactDong Jian

The Third Affiliated Hospital of Kunming Medical University (Yunnan Tumor Hospital)

dongjian18@yahoo.com+86 13888230968

Outcome results

None listed

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