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A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors (DC-CIK)

Primary Purpose

Liver Cancer, Kidney Cancer, Nasopharyngeal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CELL
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DC-CIK

Arm Description

Outcomes

Primary Outcome Measures

OS and PFS
Overall survival and progression-free survival

Secondary Outcome Measures

ORR, CR+PR
Overall response rate and quality of life

Full Information

First Posted
July 10, 2020
Last Updated
July 14, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04476641
Brief Title
A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors
Acronym
DC-CIK
Official Title
A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Kidney Cancer, Nasopharyngeal Cancer, Lung Cancer, Colorectal Cancer, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
686 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DC-CIK
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
CELL
Intervention Description
inject the DC-CIK(dendritic cell activated and cytokine induced killer cell)
Primary Outcome Measure Information:
Title
OS and PFS
Description
Overall survival and progression-free survival
Time Frame
The enrollment period was 3 years and the follow-up period was 5 years
Secondary Outcome Measure Information:
Title
ORR, CR+PR
Description
Overall response rate and quality of life
Time Frame
The enrollment period was 3 years and the follow-up period was 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianchuan Xia, doctor
Phone
02087343404
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianchuan Xia
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Tang
Phone
02087343404

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors

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