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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04476641
Other study ID # B2016-036-02
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 6, 2016
Est. completion date December 31, 2022

Study information

Verified date July 2020
Source Sun Yat-sen University
Contact Jianchuan Xia, doctor
Phone 02087343404
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 carcinoma and nasopharyngeal carcinoma, lung cancer, colon cancer, breast cancer patients with the clinical efficacy and safety of study population, including clinical liver, renal clear cell carcinoma and nasopharyngeal carcinoma, lung cancer, colon cancer, breast cancer after conventional treatment (surgery, chemotherapy and radiotherapy) patients.The primary outcome measures were overall survival and progression-free survival, while the secondary outcome measures were overall response rate and quality of life.


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 cancer, breast cancer patient safety and efficacy of plan participants included 1372 cases of the subjects, experimental group 686 cases, control group 686 cases, control group adopts the liver, renal clear cell carcinoma, nasopharyngeal carcinoma, lung cancer, colorectal cancer, breast cancer patients after conventional treatment (surgery, chemotherapy and radiotherapy) did not receive D - CIK cell therapy of external control


Recruitment information / eligibility

Status Recruiting
Enrollment 686
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- (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 Criteria:

- (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.

Study Design


Intervention

Other:
CELL
inject the DC-CIK(dendritic cell activated and cytokine induced killer cell)

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary OS and PFS Overall survival and progression-free survival The enrollment period was 3 years and the follow-up period was 5 years
Secondary ORR, CR+PR Overall response rate and quality of life The enrollment period was 3 years and the follow-up period was 5 years
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