Status:
UNKNOWN
A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors
Lead Sponsor:
Sun Yat-sen University
Conditions:
Liver Cancer
Kidney Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Main purpose of this study is through comparing with the external control, evaluation of autologous D - CIK cells immunotherapy to finish after conventional treatment of liver cancer, renal clear cell...
Detailed Description
This is a single center, single arm phase II clinical research, to evaluate the self D - CIK cells to treat liver cancer, renal clear cell carcinoma, nasopharyngeal carcinoma, lung cancer, colorectal ...
Eligibility Criteria
Inclusion
- (1) Patients diagnosed with liver cancer, renal clear cell carcinoma, nasopharyngeal carcinoma, lung cancer, colorectal cancer, breast cancer and nasopharyngeal carcinoma by imaging examination, tissue and/or cytology, and patients after conventional treatment (surgery, chemotherapy and radiotherapy); (2) No history of other tumors (except surgically cured skin squamous cell carcinoma).
- (3) Male or female, aged over 18 and under 75 (including 18 and 75 years old). (4) Physical condition: ECOG score 0 or 1. (5) Expected survival time ≥ 6 months, and follow-up was available. (6) Within 7 days before the start of treatment, the results of blood routine, liver and kidney function, and hemagglutination laboratory examination meet the following standards:White blood cell (WBC) ≥ 3.5×109/L, platelet (PLT) ≥ 80×109/L, Neutropene (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90g/L, aspartic acid transaminase (AST) \< 2.5× normal upper limit (ULN) (liver metastasis \< 5×ULN), alanine transaminase (ALT) \< 2.5×ULN (liver metastasis \< 5×ULN), total bilirubin (TIBC) \< 1.5×ULN,Serum creatinine (CR) \< 1.0×ULN, prothrombin time, partial thrombin time, plasma fibrinogen, thrombin time were within the normal range.
- (7) Female subjects must use effective contraceptives (such as prescription oral contraceptives, injectable contraceptives, iUDS, double blocking, contraceptive patch, male partner sterilization, etc.) throughout the study period;Serum or urine pregnancy test results must be negative during screening and throughout the study period.
- (8) Male subjects should take effective contraceptive measures within 1 month after receiving treatment and completing chemotherapy.
- (9) Be willing to comply with the prohibitions and restrictions stipulated in the research plan.
- (10) The subjects have signed an informed consent, stating that they understand the purpose, procedure and content of the study and are willing to participate in the study.
Exclusion
- (1) Patients with clinical symptoms of brain metastasis (except after radiotherapy).
- (2) There is an active viral or bacterial infection that cannot be controlled with appropriate anti-infective therapy.
- (3) Known to be serologically positive for HIV, syphilis, active HBV or HCV infection.
- (4) Having a mental illness or other medical condition, such as uncontrollable heart or lung disease, diabetes, etc., and failing to comply with the requirements of research treatment and monitoring.
- (5) Those who are known to be allergic to any component in cultured D-CIK cells.
- (6) Active rheumatic diseases. (7) Organ transplanters. (8) Poor compliance. (9) Women during pregnancy. (10) Lactating women.
Key Trial Info
Start Date :
May 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
686 Patients enrolled
Trial Details
Trial ID
NCT04476641
Start Date
May 6 2016
End Date
December 31 2022
Last Update
July 20 2020
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060