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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Cancer; Breast Cancer; Nasopharyngeal Cancer; Colorectal Cancer; Lung Cancer; Liver Cancer
• Intervention / Treatment: Other: 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 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

• Study Type: Interventional
• Enrollment (Anticipated): 686
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jianchuan Xia, doctor; Phone Number: 02087343404

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Yan Tang; Phone Number: 02087343404

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DC-CIK	Other: CELL; inject the DC-CIK(dendritic cell activated and cytokine induced killer cell)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS and PFS	Overall survival and progression-free survival	The enrollment period was 3 years and the follow-up period was 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR, CR+PR	Overall response rate and quality of life	The enrollment period was 3 years and the follow-up period was 5 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Jianchuan Xia, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2016
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Kidney Neoplasms; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
• Other Study ID Numbers: B2016-036-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No