Sponsor study identifier
interventional
100
1 country
1
Study Start
July 1, 2017
Actual (reported)Primary Completion
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To seek the efficacy signals of trastuzumab in combination with chemotherapy in pretreated patients of HER2 positive, relapse or metastatic carcinoma of digestive system as response rate (RR) determined by the Investigator using RECIST 1.1, and provide evidence for phase III clinical trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2017
Actual (reported)June 14, 2017
Actual (reported)July 1, 2017
Actual (reported)July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Response Rate(RR) for each cohort in intent to treat (ITT) population
The percentage of patients, whose tumor volume in first time shrink to pre-defined criteria, including CR and PR
baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
Disease control rate
baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
best overall response
10-30 weeks
HER2 positive GI tumor beyond CRC, ESCC, BTC,GC\&GEJA
HER2 positive Esophageal squamous cell carcinoma
HER2 positive Biliary tract cancer
Arm1: GI tumor beyond CRC, ESCC, BTC and GC\&GEJA Trastuzumab (Herceptin ®): 6 mg/kg every 3 weeks (8 mg/kg as loading dose at 1st administration), iv, d1.The first infusion is to be given over 90 minutes, and subsequent infusions are to be given over 30 minutes if the first infusion is well tolerated.Combined chemotherapy (by investigator's choice)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
chemotherapy in combination with trastuzumab for arm1
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordTreatment programme
chemotherapy in combination with trastuzumab for arm2
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordTreatment programme
chemotherapy in combination with trastuzumab for arm3
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordTreatment programme
chemotherapy in combination with trastuzumab for arm4
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordBeijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Xu T, Wang X, Xin Y, Wang Z, Gong J, Zhang X, Li Y, Ji C, Sun Y, Zhao F, Huang D, Bai Y, Li J, Shen L. Trastuzumab Combined with Irinotecan in Patients with HER2-Positive Metastatic Colorectal Cancer: A Phase II Single-Arm Study and Exploratory Biomarker Analysis. Cancer Res Treat. 2023 Apr;55(2):626-635. doi: 10.4143/crt.2022.1058. Epub 2022 Dec 23.
Lin Shen, Master
Director
First Submitted
May 16, 2017
First Posted
June 14, 2017
Study Start
July 1, 2017
Actual (reported)Primary Completion
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Progression free survival
baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
Overall survival
baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
time to response
6-30 weeks
HER2 positive and RAS/BRAF wild type colorectal cancer
Arm2: esophageal squamous cell carcinoma (ESCC) Trastuzumab (Herceptin ®): the same as above Combined with Irinotecan: 120 mg/m2 IV, day 1 and day 8, every 3 weeks.
Arm 3: biliary tract cancer (BTC) Trastuzumab (Herceptin®): the same as above Combined chemotherapy (by investigator's choice) The combined chemotherapy of cohort 1 and 3 is Irinotecan: 120 mg/m2 IV, day 1and day 8, every 3 weeks. OR 5-Fu: 720 mg/m2/day, continuous IV. Infusion over 5 days, every 3 weeks. OR Capecitabine(Xeloda®):1000 mg/m2 bid, d1-d14, every 3 weeks. The chemotherapy regimen is chosen at the Investigator's discretion and can be determined on an individual patient basis. Special cases should be discussed with the principal investigator.
Trastuzumab (Herceptin ®): same as above Combined with Irinotecan: 120 mg/m2 iv, day 1and day 8, every 3 weeks. OR Capecitabine(Xeloda®)1000 mg/m2 bid, d1-d14, every 3 weeks. OR Irinotecan: 120 mg/m2 iv, day 1and day 8 and Capecitabine(Xeloda®)1000 mg/m2 bid, d1-d14, every 3 weeks (by investigator's choice)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 19, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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