UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008626 |
|---|---|
| Receipt number | R000010136 |
| Scientific Title | Phase II trial of Trastuzumab + CPT-11 therapy for HER2-positive advanced gastric cancer patients with prior chemotherapy |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2025/05/25 18:00:53 |
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Basic information
Public title
Phase II trial of Trastuzumab + CPT-11 therapy for HER2-positive advanced gastric cancer patients with prior chemotherapy
Acronym
CPT-11 + Trastuzumab therapy for patients with prior chemotherapy
(HERBIS-5)
Scientific Title
Phase II trial of Trastuzumab + CPT-11 therapy for HER2-positive advanced gastric cancer patients with prior chemotherapy
Scientific Title:Acronym
CPT-11 + Trastuzumab therapy for patients with prior chemotherapy
(HERBIS-5)
Region
| Japan |
Condition
Condition
Advanced Gastric Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of CPT-11 + Trastuzumab for HER2-positive advanced gastric cancer patients with prior chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Disease Control Rate
Key secondary outcomes
Incidence and grade of AE
Progression-free survival (PFS)
Overall survival (OS)
Response Rate (RR)
Time to treatment failure (TTF)
RR stratified by prior chemotherapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug : CPT-11, and trastuzumab
CPT-11 : 150 mg/m2 iv on day 1
Every two weeks
Trastuzumab : 8 mg/kg iv on Day 1 (first course), and 6 mg/kg iv on Day 1 (from second courses) 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed unresectable or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
2. Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive)
3.Patients who provided chemotherapy and confirmed progression by images
4. Patients who have measurable region defined by RECIST version 1.1
5. Age 20 years old or older
6. Performance status (ECOG scale) 0 or 2
7. Patients who can take food oraly
8. Adequate baseline organ and marrow function as defined below;
a. Absolute neutrophil count : >=1,500/ mm3
b. Platelets : >=100,000/mm3
c. Hemoglobin: >=8.0 g/dL
d. AST (SGOT)/ALT (SGPT) : < 150 IU/L
e. Total bilirubin : <1.5 mg/dL
f. Serum creatine : =<2.0 mg/dL
9. Life expectancy of greater than 3 months.
10.LVEF(Left Ventricular Ejection Fraction) is 50% or over
11. Patients should sign a written informed consent
12. Patient with/without prior chemotherapy of Trastuzumab, or Taxan(paclitaxel or docetaxel)
Key exclusion criteria
1. with active double cancer
2. with prior chemotherapy of CPT-11
3. with local/general active infectious disease
4. Serious complication as followings,
a.bleeding on digestive tract
b.Ileus
c.intestinal paralysis
d. Interstitial pneumonia
e. Pulmonary fibrosis
f. ischemic heart disease or cardiac dysrhythmia requiring treatment
g. Heart failure
h. Renal failure
i. Hepatic cirrhosis
j. glaucoma
k. Uncontrolled diabetes mellitus
5. with uncontrollable diarrhea
6. with a history of severe allergy
7. with a middle or large volume of ascites and/or pleural fluid
8. with a continuous administration of steroids
9. with a difficulty on registration to
This study due to psychological disease
10. with a central nerve metastasis
11. With administration of atazanabil
12. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant.
13. Patients have Active hepatitis type B and/or hepatitis C.
14. Any patients judged by the investigator to be
unfit to participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Sakai |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address
2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-2641
dsakai@cfs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sakai |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address
2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-2641
Homepage URL
dsakai@cfs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department
Personal name
Funding Source
Organization
Osaka Clinical Study Supporting Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪府急性期総合医療センター（大阪府）、市立堺病院（大阪府）、西宮市立中央病院（兵庫県）、大阪府立成人病センター（大阪府）、大阪医療センター（大阪府）、八尾市立病院（大阪府）、松下記念病院（大阪府）、東大阪市立総合病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
https://academic.oup.com/jjco/article/43/8/838/895219
Publication of results
Published
Result
URL related to results and publications
https://ar.iiarjournals.org/content/45/3/1077.long
Number of participants that the trial has enrolled
30
Results
Thirty patients were enrolled, of whom 18 previously received a single chemotherapy regimen whereas 12 received two or more regimens. 29 patients were assessable for efficacy and safety. The DCR was 65.5%, and the ORR was 20.7%. The median PFS and OS were 3.7 and 7.5 months, respectively.
Results date posted
| 2025 | Year | 05 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
Eligibility criteria included unresectable or recurrent HER2-positive gastric cancer patients who were refractory to at least one regimen of chemotherapy.
Participant flow
Thirty patients were enrolled, of whom 18 previously received a single chemotherapy regimen whereas 12 received two or more regimens. As one patient withdrew before the study treatment, 29 patients were assessable for efficacy and safety.
Adverse events
The major grade 3/4 AEs were neutropenia (24%), anemia (24%), leukopenia (21%), anorexia (11%), fatigue (14%), hypoalbuminemia (24%), and hypokalemia (14%). One treatment-related death occurred.
Outcome measures
The DCR was 65.5%, and the ORR was 20.7%. The median PFS and OS were 3.7 and 7.5 months, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 05 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010136
