DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer

NCT ID: NCT02415699

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-07-31

Brief Summary

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Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DC-CIK Immunotherapy Plus Chemotherapy

Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group

Group Type EXPERIMENTAL

Fluorouracil

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Leucovorin

Intervention Type DRUG

DC-CIK

Intervention Type BIOLOGICAL

Chemotherapy Alone

Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.

Group Type ACTIVE_COMPARATOR

Fluorouracil

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Leucovorin

Intervention Type DRUG

Interventions

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Fluorouracil

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Leucovorin

Intervention Type DRUG

DC-CIK

Intervention Type BIOLOGICAL

Other Intervention Names

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5-FU

Eligibility Criteria

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Inclusion Criteria

* Stage III colon cancer
* Undergone complete resection of primary tumor
* Completed standard adjuvant chemotherapy
* ECOG performancer status 0-2
* Adequate hematologic, hepatic and renal functions

Exclusion Criteria

* HIV positive or other Immunodeficiency disease
* Uncontrolled hypertension
* History of recent cancers in the past 5 years
* Patients with previous or concurrent malignancy or any anti-cancer therapy
* Patients who were allergic to platinum drugs or fluorouracil
* Pregnant patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Xiaojian Wu, MD, PHD

Role: CONTACT

020-38254009

Other Identifiers

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2015045010

Identifier Type: -

Identifier Source: org_study_id

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