Unique ID issued by UMIN | UMIN000001791 |
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Receipt number | R000002161 |
Scientific Title | Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer |
Date of disclosure of the study information | 2009/05/01 |
Last modified on | 2018/03/30 09:25:47 |
Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer
Epitope Peptides with mFOLFOX6 for metastatic CRC
Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer
Epitope Peptides with mFOLFOX6 for metastatic CRC
Japan |
Metastatic chemo naive colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
YES
To determine the efficacy and safety of the combination therapy with mFOLFOX6 and novel epitope peptides for unresectable chemo-naïve colorectal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
the efficacy (response rate, time to progression)
1. Safety
2. Over all survival
3. Induction of immune responses
4. Progression free survival
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
HLA-A2402 positive
HLA-A2402 negative
20 | years-old | <= |
Not applicable |
Male and Female
1. Histological proven colorectal cancer
2. PS:0 to 1(ECOG performance status score)
3. One or more RECIST lesions
4. chemo-naive
5. Good function of critical organs
6. Suspect for more than 3 months alive
7. Written informed consents
1. Severe heart diseases
2. Wish for pregnancy
3. Active infection
4. Steroid or immunosuppressive therapy
5. Allergy for using epitope peptides
6. Mental and nervous disorder
7. Massive pleural or abdominal effusions
8. Peripheral nervous disorder
9. Diarrhea
10. Doctors opinion
100
1st name | |
Middle name | |
Last name | Masaaki Oka |
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
0836-22-2264
hazama@yamaguchi-u.ac.jp
1st name | |
Middle name | |
Last name | Shoichi Hazama |
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
0836-22-2264
hazama-jsgs@umin.ac.jp
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
Yamaguchi University
Tokyo University
Other
NO
山口大学大学院消化器・腫瘍外科学
(Department of Digestive Surgery and Surgical Oncology (Department of Surgery II), YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE)
2009 | Year | 05 | Month | 01 | Day |
Published
http://meetinglibrary.asco.org/content/113655-132
J Transl Med. 2014 Apr 30;12:108. doi: 10.1186/1479-5876-12-108.
2013 ASCO Annual Meeting
J Clin Oncol 31, 2013 (suppl; abstr 3006)
Oral Abstract Session, Developmental Therapeutics - Immunotherapy
Abstract:
We further performed a phase II trial to evaluate the benefit of the cancer vaccination in combination with oxaliplatin-based chemotherapy as first-line therapy. Methods: Ninety-six chemotherapy naïve CRC pts were enrolled to evaluate primarily response rates (RR), and secondarily OS and PFS. Each of the five peptides (3 mg each) was mixed with 1.5 ml of IFA and subcutaneously administered weekly for 12 weeks and after then biweekly. Chemotherapy was performed simultaneously as mFOLFOX6 or XELOX with/without bevacizumab. All enrolled pts had received the therapy without knowing HLA-A status double-blindly, and the HLA genotype were key-opened at analysis point and then, the endpoints are evaluated between HLA-A*2402 positive and HLA-A*2402 negative group. Results: Between February 2009 and November 2012, a total of 96 pts were enrolled in this study. The cutoff date for the main analysis was January 31, 2013 (median duration of follow-up of 26.5months). mFOLFOX6 and XELOX were administered to 93 and 3 pts, respectively. Bevacizumab was used for 5 pts. RR, the primary study end point, was 61.5% (CR 1, PR 58, SD 33, PD 4). It seemed superior as compared to other reports. The median duration to reach the best responses (14 weeks; range 8-69) was surprisingly long and indicated the delayed effect of vaccination. PFS and OS were 8.2 m and 20.7 m, respectively. The HLA genotype will be key-opened at March 2013 and the endpoints will be presented between HLA-A*2402 positive and negative group at the meeting. Conclusions: The phase II cancer vaccine therapy demonstrated the promising response, and warrants further clinical studies. Clinical trial information: UMIN000001791.
Completed
2008 | Year | 12 | Month | 20 | Day |
2009 | Year | 01 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2009 | Year | 03 | Month | 23 | Day |
2018 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002161
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