DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First People's Hospital of Changzhou

About this trial

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven renal cell carcinoma

Age: > 18

WHO- ECOG Performance Status 0-1

At least one measurable tumor lesions according to the RECIST criteria.

Disqualifiers

Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).

Patients with metastatic disease in the central nervous system (CNS).

Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.

Patients with acute or chronic infection including HIV.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DC-CIK

    Biological/Vaccine

    Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.

  • IL-2/IFN-α

    Biological/Vaccine

    Patients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: DC-CIKExperimental treatment 1 intervention
Group B: IL-2/IFN-αOther 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free time

Time frame
3 months
2

Overall-survival time

Time frame
3 months

Secondary outcomes

1

Objective tumor response

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: