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

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ClinicalTrials.gov Identifier: NCT02415699
Recruitment Status : Not yet recruiting
First Posted : April 14, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Fluorouracil Drug: Oxaliplatin Drug: Leucovorin Biological: DC-CIK Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
Study Start Date : August 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: Fluorouracil
Other Name: 5-FU

Drug: Oxaliplatin
Drug: Leucovorin
Biological: DC-CIK
Active Comparator: Chemotherapy Alone
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
 Drug: Fluorouracil
Other Name: 5-FU

Drug: Oxaliplatin
Drug: Leucovorin


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
  2. Side Effect [ Time Frame: 6 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415699


Contacts
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Contact: Xiaojian Wu, MD, PHD 020-38254009 sumswxj@126.com

Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
More Information
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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02415699     History of Changes
Other Study ID Numbers: 2015045010
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents