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Status unknownNCT03047525Updated Feb 9, 2017

Study of DC-CTL Combined With CIK for Advanced Solid Tumor

A Phase 1/2 interventional study of Cytokine-induced Killer Cells in Colorectal Cancer, Renal Cell Carcinoma and Nasopharyngeal Carcinoma, sponsored by Xiaoyi Huang. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-09.

Sponsored by Xiaoyi Huang · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

02

Conditions studied

  • Colorectal Cancer
  • Renal Cell Carcinoma
  • Nasopharyngeal Carcinoma
  • Lung Cancer

Keywords

  • cytokine-induced killer cell
  • dendritic and cytokine-induced killer cells
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 200 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with Xiaoyi Huang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with treatment-refractory advanced colorectal cancer can not accept operation .
  2. Age 18 to 75 years.Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival > 3 months;
  3. 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;
  4. Without any other malignant disease;
  5. With more than one scalable lesions
  6. Patients Voluntary attempt, and informed consent.
  7. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

Exclusion criteria

Exclusion Criteria:

  1. Patients who do not conform to the inclusion criteria;;
  2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening(such as uncontrolled brain metastasis ); Patients who were pregnant or lactating;
  3. ECOG perform status ≥ 2;
  4. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)..
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • No intervention
    control group

    patients will just regularly chemotherapy

  • Experimental
    DC-CIK and CIK Immunotherapy

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

    Biological: Cytokine-induced Killer Cells

Interventions

  • BiologicalCytokine-induced Killer Cells

    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

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What researchers measure

Primary outcomes

  1. progression-free survival(PFS)

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, China
    • Yi X Huang · Contact · +8618745796786
    • Qi Li · Contact · +8613936344890
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03047525
Lead sponsor
Xiaoyi Huang
Responsible party
Xiaoyi Huang (Director of The Heilongjiang Cancer Biotherapy Center, Harbin Medical University) — Sponsor-investigator
First posted
Feb 9, 2017
Start date
Feb 20, 2017 (estimated)
Primary completion
Jan 1, 2019 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Feb 9, 2017

Study contacts

Xiaoyi Huang
Contact
+8618745796786
Qi Li
Contact
+8613936344890

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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