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Trial of Antigen Pulsed Dendritic Cells (APDC) in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02503150
Recruitment Status : Not yet recruiting
First Posted : July 20, 2015
Last Update Posted : July 30, 2015
Sponsor:
Collaborators:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Changhai Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Shanghai Changzheng Hospital
Zhejiang Cancer Hospital
Chinese PLA General Hospital
Beijing Cancer Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
First People's Hospital of Hangzhou
The 307th Hospital of Chinese People`s Liberation Army
Huashan Hospital
Ruijin Hospital
Shanghai Haixin Biotechnology Co. Ltd
Information provided by (Responsible Party):
Second Military Medical University

Brief Summary:
This trial is to compare the efficacy and safety of modified FOLFOX6 [mFOLFOX6, a specific chemotherapy regimen of Oxaliplatin ,5-Fluorouracil and Leucovorin] chemotherapy plus Antigen Pulsed Dendritic Cells (APDC,a kind of autologous tumor lysates pulsed human dendritic cells vaccine) with modified chemotherapy alone in patients with metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Biological: APDC + Chemotherapy Drug: Chemotherapy Phase 3

Detailed Description:
Metastatic colorectal cancer (CRC) patients will be randomly assigned (3:1) to receive either modified FOLFOX6 [mFOLFOX6] chemotherapy combined with Antigen Pulsed Dendritic Cells (Arm APDC + Chemotherapy), or chemotherapy alone (Arm Chemotherapy). Each patient recruited in the study will receive maximum 12 cycles of (14 days/cycle) mFOLFOX6 chemotherapy. Patients in Arm APDC + Chemotherapy will receive APDC vaccination in addition to chemotherapy in the cycle 1-3 and 7-9, and in cycle 4-6 and 10-12 receive only chemotherapy. APDC + Chemotherapy or Chemotherapy will be stopped in case of disease progression, intolerable toxicities, or patient withdrawal with the consent. After 12 cycles, patients in Arm APDC + Chemotherapy will receive 5-Fluorouracil treatment plus every 3 months APDC therapy and patients in Arm Chemotherapy will receive only 5-Fluorouracil treatment. PFS, ORR and OS will be assessed, and toxicity and immunologic effects will be monitored.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of Antigen Pulsed Dendritic Cells (APDC) Combined With Chemotherapy in Metastatic Colorectal Cancer
Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APDC + Chemotherapy
Patients in Arm APDC + Chemotherapy will receive APDC combined with chemotherapy.
Biological: APDC + Chemotherapy
Patients in Arm APDC+Chemotherapy receive maximum 12 cycles (14days/cycle) mFOLFOX6 chemotherapy. Each cycle chemotherapy consist of Oxaliplatin at 85mg/ m2 infused for 2 hours only on day 1,and Leucovorin at 400 mg/m2 was administered intravenously for 2 hours, followed by continuous intravenous administration of 5-Fluorouracil at 400 mg/m2 (2.4g/m2 for 46 hours).On day 8 of cycle1-3 and 7-9, patients also receive APDC vaccine infusion in 100ml saline. After 12 cycles, patients in Arm APDC+chemotherapy will receive 5-Fluorouracil /Leucovorin (Leucovorin at 400 mg/m2/day administered intravenously for 2 hours, intravenous bolus of 5-Fluorouracil at 400 mg/m2 , followed by continuous intravenous administration of 5-Fluorouracil at 1200 mg/m2/d for 2 days, repeated every 2 weeks) plus APDC therapy (once every 3 months). Treatments will continue unless disease progression, intolerable toxicity or patients withdrawal).

Active Comparator: Chemotherapy
Patients in Arm Chemotherapy will receive chemotherapy only.
Drug: Chemotherapy
Patients in Arm Chemotherapy receive maximum 12cycles (14days/cycle) mFOLFOX6 chemotherapy. Each cycle chemotherapy consist of Oxaliplatin at 85mg/ m2 infused for 2 hours only on day 1, and Leucovorin at 400 mg/m2 was administered intravenously for 2 hours, followed by continuous intravenous administration of 5-Fluorouracil at 400 mg/m2 (2.4g/m2 for 46 hours). After 12 cycles, patients in Arm chemotherapy will receive only 5-Fluorouracil /Leucovorin (Leucovorin at 400 mg/m2/day administered intravenously for 2 hours, intravenous bolus of 5-Fluorouracil at 400 mg/m2 , followed by continuous intravenous administration of 5-Fluorouracil at 1200 mg/m2/d for 2 days, repeated every 2 weeks). Treatments will continue unless disease progression, intolerable toxicity or patients withdrawal).




Primary Outcome Measures :
  1. Progression Free Survival, PFS [ Time Frame: Up to approximately six years ]
    Time from the randomization date to the start of disease progression (progression assessed by investigator using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1 guidelines) for metastatic colorectal cancer subjects.


Secondary Outcome Measures :
  1. Objective Response [ Time Frame: Up to approximately six years ]
    From randomisation to occurrence of objective response( complete regression (CR) and partial regression (PR) need to be confirmed 28 days after the occurrence)

  2. Overall Survival, OS [ Time Frame: Up to approximately six years ]
    From randomisation to the time of death of any cause.

  3. Clinical benefit Rate [ Time Frame: Up to approximately six years ]
    From randomisation to confirmation of objective response

  4. Quality of Life [ Time Frame: Up to approximately six months ]
    From randomisation to the end of all treatments (according to the EORTC QLQ-C30: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C30)

  5. Adverse Events [ Time Frame: Up to approximately six years ]
    From randomisation to the end of follow-up



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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:

  1. Histologically confirmed adenocarcinoma of the colorectum with metastatic lesions and received no previous therapy for metastatic lesions;
  2. Be able to undergo surgical resection to obtain at least 1cm3 tumor tissues;
  3. The patients are from 18-75 years old regardless of gender;
  4. An estimated life expectancy of more than 6 months with ECOG≤2;
  5. Adequate hepatic, renal, and bone marrow functions: neutrophilic granulocyte≥1.5×109/L, Hb(hemoglobin)≥90g/L, PLT(platelets)≥100×109/L, serum Cr(creatinine)≤1.5-time upper normal limit, serum TBIL(total bilirubin)≤1.5-time upper normal limit, both serum ALT and AST(alanine aminotransferase and aspartate aminotransferase)≤2.5-time upper normal limit, hepatic metastases CRC patients' serum ALT/AST≤5-time upper normal limit;
  6. At least one measurable lesion after surgical resection (According to the standard of RECIST1.1 version: Response Evaluation Criteria in Solid Tumors 1.1 version);
  7. Written informed consent.

Exclusion Criteria:

  1. Severe (ie, active) heart disease, such as coronary heart disease symptoms, the New York Heart Association (NYHA) II-class or more serious congestive heart failure or severe arrhythmia requiring medication intervention, or history of myocardial infarction within the last 12 months; severe pulmonary dysfunction; peripheral neuropathy; unstable hypertension;
  2. Metastases lesions> 50% of liver volume;
  3. Autoimmune diseases, organ transplantation requiring immunosuppressive therapy and patients requiring long-term systemic corticosteroid therapy;
  4. History of other malignant diseases (except cured basal cell carcinoma and cervical carcinoma in situ) in the last 5 years;
  5. Pregnant or lactating women (women at childbearing age in the baseline pregnancy test positive or pregnancy test not examined. Menopausal women have menopause at least 12 months);
  6. Acute or chronic infectious diseases in active phase; severe uncontrolled infection, or other serious uncontrolled concomitant diseases;
  7. Definite history of allergy or allergic constitutions;
  8. Chemotherapy, radiotherapy or immunotherapy within four weeks;
  9. Administration of other investigational drugs or procedures within four weeks.

Information from the National Library of Medicine

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): NCT02503150


Contacts
Contact: Lan Bai, Mastor +86 18621696315 bailan@hisunbio.com
Contact: Ke Wang, Bachelor +86 13761172785 wangke@immunol.org

Sponsors and Collaborators
Second Military Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Changhai Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Shanghai Changzheng Hospital
Zhejiang Cancer Hospital
Chinese PLA General Hospital
Beijing Cancer Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
First People's Hospital of Hangzhou
The 307th Hospital of Chinese People`s Liberation Army
Huashan Hospital
Ruijin Hospital
Shanghai Haixin Biotechnology Co. Ltd
Investigators
Study Chair: Xuetao Cao, M.D.,Ph.D. Second Military Medical University
Study Director: Tao Wan, Ph.D. Second Military Medical University
Principal Investigator: Yuankai Shi, M.D.,Ph.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party: Second Military Medical University
ClinicalTrials.gov Identifier: NCT02503150     History of Changes
Other Study ID Numbers: SMMU, Shanghai
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by Second Military Medical University:
Colorectal Cancer
Tumor Therapeutic Vaccine
Dendritic Cell

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases