NCT03047525

Brief Summary

Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop cancer cells from growing. The investigators suppose that DC-CIK combined with CIK treatment will improve the prognosis of advanced solid tumors. Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors. Study treatment: Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available in both groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1 colorectal-cancer

Timeline
Completed

Started Feb 2017

Typical duration for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

February 7, 2017

Last Update Submit

February 8, 2017

Conditions

Colorectal CancerRenal Cell CarcinomaNasopharyngeal CarcinomaLung Cancer

Keywords

cytokine-induced killer celldendritic and cytokine-induced killer cells

Outcome Measures

Primary Outcomes (1)

  • progression-free survival(PFS)

    1 month

Study Arms (2)

control group

NO INTERVENTION

patients will just regularly chemotherapy

DC-CIK and CIK Immunotherapy

EXPERIMENTAL

patients will receive chemotherapy with 4 cycles of DC-CIK treatment and 4 cycles of CIK treatment .

Biological: Cytokine-induced Killer Cells

Interventions

Cytokine-induced Killer CellsBIOLOGICAL

Concurrent of chemotherapy plus 4 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment and 4 cycles of Cytokine-induced Killer Cells(CIK) treatment

Also known as: DC-CIK and CIK
DC-CIK and CIK Immunotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with treatment-refractory advanced colorectal cancer can not accept operation .
  • Age 18 to 75 years.Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival \> 3 months;
  • Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count(PLT)≥ 80×109/L; Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
  • Without any other malignant disease;
  • With more than one scalable lesions
  • Patients Voluntary attempt, and informed consent.
  • Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

You may not qualify if:

  • Patients with uncontrolled infection; underlying disease that was severe or life-threatening(such as uncontrolled brain metastasis ); Patients who were pregnant or lactating;
  • ECOG perform status ≥ 2;
  • Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, China

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsCarcinoma, Renal CellNasopharyngeal CarcinomaLung Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Xiaoyi Huang

CONTACT

+8618745796786

Qi Li

CONTACT

+8613936344890

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of The Heilongjiang Cancer Biotherapy Center

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

February 20, 2017

Primary Completion

January 1, 2019

Study Completion

December 1, 2020

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

CN(1)