UMIN-CTR Clinical Trial

Public title

Clinical study on medical value of adoptive immunotherapy with chemotherapy
for stage IV colorectal cancer

Acronym

COMVI IV study

Scientific Title

Clinical study on medical value of adoptive immunotherapy with chemotherapy
for stage IV colorectal cancer

Scientific Title:Acronym

COMVI IV study

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluate the safety of the combination treatment of adoptive immunotherapy with chemotherapy for stage IV colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

Safety

Key secondary outcomes

Efficacy
- Progression-free survival
- Overall survival
- Response rate
- Immunological responses

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Oxaliplatin 130mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine2,000mg/m2,p.o.(day1-14)
Autologous alfa/beta T cells i.v.
to be repeated every 3 weeks

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Histologically confirmed colorectal cancer
2. Treatment plan of XELOX(+-bevacizumab) for colorectal cancer
3.No prior chemotherapy for colorectal cancer
4.Performance Status: 0-1 (ECOG criteria)
5.Age: 20 years old or older
6.Signed written informed consent
7.Vital organ functions are preserved within 14 days prior to entry
Neutrophil:>=1,500/mm3
Platelet:>=75,000/mm3
Hb.:>= 8.0 mg/dl
T.bil.:<= 2.0 mg/dl
Creatinin:<=2.0mg/dl

Key exclusion criteria

1.Prior severe drug allerg
2.Presence of active infection
3.Multiple malignancy within 5 years disease free interval
4.Uncontrolled hypertension or diabetes
5. Severe peripheral nerve disorder
6.Chronic systemic treatment of corticosteroid
7.Nursing or pregnant females, or females or males with female partners who are planning to pregnancy
8.Inadequate for study enrollment by the physician
9.Anti-HIV antibody(+),Anti-HTLV-1 antibody(+)

Target sample size

6

Name of lead principal investigator

1st name	Yoichiro
Middle name
Last name	Yoshida

Organization

Fukuoka University School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

814-0180

Address

7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan

TEL

092-801-1011

Email

yyoshida@fukuoka-u.ac.jp

Name of contact person

1st name	Yoichiro
Middle name
Last name	Yoshida

Organization

Fukuoka University School of Medicine

Division name

Gastroenterological Surgery

Zip code

814-0180

Address

7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan

TEL

092-801-1011

Homepage URL

Email

yyoshida@fukuoka-u.ac.jp

Institute

Fukuoka University School of Medicine Department of Gastroenterological Surgery

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukuoka University

Address

7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan

Tel

092-801-1011

Email

yyoshida@fukuoka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学病院（福岡県）
瀬田クリニック（福岡県）

Date of disclosure of the study information

2013

Year

06

Month

08

Day

URL releasing protocol

https://ar.iiarjournals.org/content/37/7/3941.short

Publication of results

Published

URL related to results and publications

https://ar.iiarjournals.org/content/37/7/3941.short

Number of participants that the trial has enrolled

6

Results

The overall response rate was 83.3% [complete response in two (33.3%); partial response in three (50.0%); stable disease in one (16.7%); no cases of progressive disease]. The tumor volume reduction rate was 53% (range=38.0-100%). The median progression-free and overall survival durations were 567 and 966 days, respectively. Most adverse events were mild-to-moderate in intensity, and no grade 4 adverse events occurred in the six patients. Only one patient experienced grade 3 hypertension and ileus.

Results date posted

2023

Year

06

Month

16

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Patients who met the following criteria were excluded: interstitial lung disease, autoimmune disease, clinically significant cardiovascular disease, active infection, history of serious hypersensitivity to drugs, systemic steroid administration, pregnant women, multiple primary cancers within the past 5 years, positive human immunodeficiency virus test result or human T-cell lymphotropic virus type I test result, and any other conditions that made the patient unsuitable for this study.

Participant flow

The COMVI study was designed as a prospective, open-label, nonrandomized, and single-arm clinical trial in Japan. This study was performed in accordance with the ethical guidelines for clinical studies. The institutional review board at Fukuoka University approved the protocol, and the study has been registered with the University Hospital Medical Information Network Clinical Trials Registry (ID: UMIN000010908).
The study evaluated the safety and feasibility of combination therapy involving adoptive immunotherapy and chemotherapy for advanced or recurrent stage IV CRC. The primary endpoint was safety. The secondary endpoints were the objective tumor response rate and progression-free survival (PFS). The target sample size was 6 patients.

Adverse events

Grade 3 or higher hemotoxicity did not occur in any patient, and 1 patient (16.7%) developed grade 3 nonhematological toxicity (hypertension). There were no other severe treatment-related adverse events and no treatment-related death.

Outcome measures

The confirmed response rate was 83.3% (complete response [CR], 33.3%; partial response [PR], 50.0%; stable disease [SD], 16.7%; progressive disease [PD], 0%), and the disease control rate was 100%. The median PFS and overall survival (OS) durations were 567 and 966 days, respectively.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

05

Month

18

Day

Date of IRB

2013

Year

05

Month

18

Day

Anticipated trial start date

2013

Year

06

Month

10

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

06

Month

08

Day

Last modified on

2023

Year

06

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012763