Trial Title:
Clinical Study on the Efficacy of Autologous Cell Factor Induced Killer Cells in the Treatment of Colorectal Cancer
NCT ID:
NCT05676190
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Immunomodulating Agents
Conditions: Keywords:
Autologous cytokine induced killer cells
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
CIK combined with chemotherapy group
Description:
Combination of chemotherapy and autologous cytokine induced killer cells
Arm group label:
CIK combined with chemotherapy group
Intervention type:
Combination Product
Intervention name:
CIK combined immunotherapy group
Description:
Combination of immunotherapy and autologous cytokine induced killer cells
Arm group label:
CIK combined immunotherapy group
Intervention type:
Combination Product
Intervention name:
CIK combined targeted therapy group
Description:
Combination of targeted therapy and autologous cytokine induced killer cells
Arm group label:
CIK combined targeted therapy group
Intervention type:
Combination Product
Intervention name:
CIK in combination with other therapies
Description:
CIK combined with any two or three of them (i.e. chemotherapy, immunotherapy and targeted
therapy)
Arm group label:
CIK in combination with other therapies
Summary:
This project plans to use CIK combined with chemotherapy, immunotherapy and targeted
therapy to treat CRC patients, so as to explore the effectiveness of CIK treatment and
the CRC subtypes more suitable for CIK treatment, thereby improving the survival rate and
quality of life of CRC patients.
Detailed description:
Colorectal cancer (CRC) is a malignant tumor that seriously threatens human health, and
according to the international agency for research on cancer (IARC) data, in 2018, the
number of new cases of CRC totalled more than 1.8 million and the number of deaths
totalled more than 88million, making it the third most common cancer worldwide [1]. In
recent years, with the development of economic level in China, changes in lifestyle and
dietary structure, the incidence and mortality of CRC have shown a continuous increasing
trend, and it is ranked 5th in all malignant tumors. According to statistics, at present,
our country has 376000 new CRC cases and 191000 deaths annually, and the whole face
extremely serious challenges.
Patients with advanced CRC have a more complicated disease, and the 5-year survival rate
is even less than 5%. A single therapeutic means cannot achieve the desired therapeutic
effect, and often multiple therapeutic modalities are used for intervention, including
surgery, radiotherapy, chemotherapy, interventional minimally invasive treatment,
immunotherapy and molecular targeting, etc. Because of the potential efficacy of CIK
treatment in controlling tumor growth and prolonging patient survival, but there are
still few clinical studies about CIK combined with other treatment modalities, this
protocol is intended to use CIK combined with chemotherapy, immune and targeted therapy
in CRC patients, in order to explore the effectiveness of CIK treatment and more suitable
CRC subtypes for CIK treatment, and then improve the survival rate and quality of life of
CRC patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age range 18-70 years;
- Patients diagnosed with colorectal cancer, TNM stage III-IV;
- Had at least one extracranially measurable lesion by recist1.1 criteria; ④
Patients who had failed at least one or two prior lines of standard
therapy or relapsed, or who were intolerant to or voluntarily abandoned
one or two prior lines of standard therapy; ⑤ Expected survival ≥ 90 days;
- The major organs function normally; ⑦ The subject voluntarily joined
this study, signed the informed consent, complied well and cooperated
with the follow-up.
Exclusion Criteria:
- Had participated in other clinical trialists of drugs within 4 weeks before the
start of the study;
- Those who had hypertension that was inadequately controlled with a single
antihypertensive agent (systolic blood pressure > 140 mmHg and diastolic blood
pressure > 90 mmHg, as judged by the investigator), had myocardial ischemia or
myocardial infarction of grade I or higher, arrhythmia of grade I and higher
(including QT interval ≥ 440 MS), or cardiac dysfunction;
- Those with a history of substance abuse who are unable to abstain or who
have a history of mental disorders;
- Presence of fungal, bacterial, viral, or other infections that are
not controllable or require antibiotic therapy;
- For subjects with prior chemotherapy use, ≥ grade 2 hematologic
toxicity, or ≥ grade 3 nonhematologic toxicity according to
nci-ctcae 5.0 criteria at enrollment; ⑥ Known presence of a
history of HIV, or hepatitis B (HBsAg positive) or hepatitis C
virus (anti HCV positive) nucleic acid test positive;
- Presence of any indwelling catheter or drain (eg, biliary
drain or pleural / peritoneal / pericardial catheter). Use
of a dedicated central venous catheter was permitted
(colostomy for patients with bowel cancer, percutaneous
nephrostomy tube, indwelling Frey catheter, considered by
the investigator for implications); ⑧ Presence of brain
metastases, presence of a history or disease of the CNS
such as seizure disorders, cerebral ischemia / hemorrhage,
dementia, cerebellar disease, or any autoimmune disease
involving the CNS;
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Southwest Hospital, Army Medical University (Third Military Medical University)
Address:
City:
Chongqing
Zip:
400038
Country:
China
Status:
Recruiting
Contact:
Last name:
shicang yu, M.D. and Ph.D.
Phone:
023-68766452
Email:
yushicang@163.com
Start date:
January 9, 2023
Completion date:
April 30, 2027
Lead sponsor:
Agency:
ShiCang Yu
Agency class:
Other
Source:
Southwest Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05676190
