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Status unknownNCT04214717DC-CIKUpdated Mar 28, 2023

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

An interventional study of DC-CIK combined with Chemotherapy and Chemotherapy in Solid Tumor, sponsored by Yantai Yuhuangding Hospital. Status unknown at 1 site in China. Open to participants aged 10 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Yantai Yuhuangding Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 90 Years
Sex
All
01

Study summary

Combinations of Dendritic cell-activated cytokine-induced killer cell (DC-CIK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

Read the detailed description

Patients in group A will receive 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of DC-CIK with chemotherapy in patients with treatment-refractory solid tumors.

02

Conditions studied

  • Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Yantai Yuhuangding Hospital is the lead sponsor of 16 studies on the registry; 6 are open to participants now.

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

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Who can participate

Ages eligible
10 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with treatment-refractory advanced solid cancer can not accept operation;
  2. Age 10 to 90 years;
  3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
  4. Estimate survival > 3 months;
  5. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
  6. Without any other malignant disease;
  7. With more than one scalable lesions;
  8. Patients Voluntary attempt, and informed consent;
  9. 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 );
  3. Patients who were pregnant or lactating;
  4. ECOG perform status ≥ 2;4.
  5. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Combination of DC-CIK with chemotherapy group

    Patients will receive DC-CIK treatments combined with Chemotherapy .

    Combination Product: DC-CIK combined with Chemotherapy

  • Active comparator
    Chemotherapy group

    Patients will only receive Chemotherapy.

    Drug: Chemotherapy

Interventions

  • Combination productDC-CIK combined with Chemotherapy

    Patients will receive 4 cycles of DC-CIK treatments combined with Chemotherapy within 8 months.

  • DrugChemotherapy

    Patients will only receive Chemotherapy.

06

What researchers measure

Primary outcomes

  1. Disease Control Rates (DCR)

    Disease Control Rates (Complete Remission + Partial Remission + Stable Disease), according to solid tumor response evaluation standard (Response evaluation criteria in solid tumors, RECIST).

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Yantai Yuhuangding Hospital
    Yantai, Shandong 264000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

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 Mar 28, 2023, 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
NCT04214717
Lead sponsor
Yantai Yuhuangding Hospital
Responsible party
Peiwen Lian (Principle Investigator, Yantai Yuhuangding Hospital) — Principal investigator
First posted
Jan 2, 2020
Start date
Dec 31, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 28, 2023

Study contacts

Peiwen Lian, PhD
Contact
peiwen.lian@hotmail.com
+0086 5356691999 ext. 82708
Jian Chen, PhD
Contact
chenjianyt@163.com
+0086 5356691999 ext. 81511
Peiwen Lian, PhD
study director · Yantai Yuhuangding Hospital

Oversight

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 Mar 2023. You cannot join it, but the record below documents what was studied.

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