Targeted TherapyPhase 2NCT03185988
Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System
A Phase 2 study testing chemotherapy in combination with trastuzumab for arm1, chemotherapy in combination with trastuzumab for arm2 and chemotherapy in combination with trastuzumab for arm3 in people with Targeted Therapy and HER2, run by Shen Lin at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Targeted Therapy, HER2, Biliary Tract Cancer
- What is being tested?
- chemotherapy in combination with trastuzumab for arm1, chemotherapy in combination with trastuzumab for arm2 and chemotherapy in combination with trastuzumab for arm3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Male and female patients aged from 18 to 75 years
- Histologically confirmed Colorectal cancer,Esophagus squamous cell carcinoma, biliary tract cancer, and digestive system tumor beyond CRC and GC\&GEJA with the following specifications:
- genetic testing conformed KRAS/NRAS/BRAF all wild type for colorectal cancer
- Detection of a carcinoma with HER2 3+ (IHC) or HER2 2+ (IHC) with amplification proven by fluorescence in situ hybridization(FISH), silver in situ hybridization（SISH） or chromogenic in situ hybridization（CISH） using gastric cancer criteria by an accredited local pathologist.
- Relapse or metastatic diseases, at least one measurable lesion according to RECIST 1.1, anticipated survival ≥ 12 weeks.
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- ECOG Performance status 0-1.
- Patients who failed at least first line systemic therapy.
- Adequate organ function as determined by the following laboratory results:
- Absolute neutrophil count ≥1500 cells/mm3,
- Platelet count ≥ 90,000 cells/mm3,
- Hemoglobin ≥9.0 g/dL
- Total bilirubin ≤ 1.5 upper limit of normal (ULN).
- serum glutamate oxaloacetate transaminase(SGOT,AST), serum glutamate pyruvate transaminase(SGPT,ALT) < 2.5 ULN without liver metastases; < 5 ULN with liver metastases.
- serum creatinine < 1.5
- ULN OR creatinine clearance ≥ 40 mL/ min.
- If able to reproduce, patients must be willing to use highly effective methods of contraception during treatment and for 7 months after the end of treatment.
Who cannot join
- Known hypersensitivity against treatment regimen.
- Baseline left ventricular ejection fraction(LVEF) < 50% (measured by echocardiography or MUGA).
- Previous anti-her treatment.
- Immune therapy, biological therapy or any participation in clinical trial in previous two weeks.
- Surgery and not recovered in previous three weeks
- Clinical evidence of brain metastases, or uncontrolled epilepsy.
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- Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, New York Heart Association(NYHA) III-IV; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; unstable angina pectoris, myocardial infarction or high risk uncontrollable arrhythmias.
- Long term or high dose corticosteroids administration ( inhalation or short term oral administration for antiemesis and orexigenic is allowed)
- Patients of legally incapacity or of medical and ethical reasons not fit for study.
- Pregnant or lactating, or intending to become pregnant during the study.
- Jaundice, ascites, and / or alkaline phosphatase ≥3 × ULN; and / or ≥3 grade (CTC-AE) of persistent proteinuria, urinary protein / creatinine ratio> 3.5g / 24 hours or renal failure need blood or peritoneal dialysis.
- Presence of > grade 2(CTC-AE) persistent infection; unhealed wounds, ulcer or fracture, or patients with a history of organ transplant.
- Evidence of coagulation disorders. Like presence ≥grade 3 (CTC-AE) bleeding events.
- Known HIV or hepatitis B virus(HBV), hepatitis C virus(HCV) infection.
- Any > grade 1 unresolved toxicity due to previous treatment (CTC-AE), except for alopecia, anemia and hypothyroidism).
- Not suitable for the study evaluated by investigators
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- History of exposure to the following cumulative doses of anthracyclines:
- Doxorubicin > 500 mg/m2 OR Epirubicin > 720 mg/m2.
- If another anthracycline or more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
xicheng wang, Doctor, 88196561, xicheng_wang@hotmail.com
About this study
Official title: Multicenter, Phase II Study of Chemotherapy in Combination With Trastuzumab in Patients of Pretreated, HER2 Positive, Relapse or Metastatic Carcinoma of Digestive System
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.
Read the detailed description
Human epidermal growth factor receptor 2, (HER2) is overexpressed /amplified in multiple carcinomas, for example, gastric cancer(GC), gastroesophageal junction adenocarcinoma(GEJA),and breast cancer.And HER2 is closely related to tumor proliferation \&metastases.About 90% Chinese esophagus cancer are squamous cell origin. The reported HER2 overexpression ranged from 5-30%, Beijing cancer hospital reported an 11% positive rate. The variety of HER2 positive rate may because of the absence of standard HER2 testing criteria. The current treatment for metastatic Esophageal squamous Cell Carcinoma (ESCC) is not satisfactory. Fluorouracil and platinum are considered as first line standard of care (SOC) with a 20-30% RR and 7-9 months overall survival (OS). In second line setting, there is no SOC in china. And the efficacy is not satisfactory. Esophageal adenocarcinoma has a higher HER2 positive rate of 14%, but no data reported of using trastuzumab in these patients in China. Biliary tract cancer (BTC), including intrahepatic/extrahepatic cholangiocarcinoma and Gallbladder cancer (GBC) is very aggressive, total 5y survival is less than 5% for unresectable patients. GBC is account for approximately 2/3 of BTC, and it's estimated the incidence in china is 52800 and the mortality is 40700 in 2015. Most patients are diagnosed in advanced stage and lose the opportunity of surgery. However, there is no SOC for unresectable BTC, gemcitabine plus platinum provided a 30% RR and 10 month OS. In second line treatment, no differences were seen between various experimental agents. The reported HER2 positive rate range from 5.1% to 57% in biliary duct cancer and 4.7% to 64% in GBC. Researchers reported her2 amplification is related to tumor stage and lymph nodes metastasis in 221 BTC patients. Another study reported a 16.6% positive rate and worse prognosis with a sample size of 230 GBC patients. Meanwhile, HER2 pathway mutation rate reached 37%. All imply that BTC may be the potential anti HER therapy population. Besides, other digestive system tumor has low HER2 positive rate (Small intestinal cancer 0.9-3%; hepatocellular carcinoma 2.4%; Pancreatic cancer 3%; etc.). However, the patient pool is large and has no SOC in second Line. Whether these HER2 + patients can gain benefit form anti- her treatment is worth investigating. In 2016 American Society of Clinical Oncology (ASCO), a study reported that using trastuzumab and pertuzumab combination, 35% metastatic colorectal cancer (CRC) and 50% BTC patients who heavily pretreated had objective response. However, china doesn't have studies for these patients. .
The concurrent basket trial will explore the efficacy and safety of trastuzumab with chemotherapy in Chinese patients of pretreated, HER2 positive, relapse or metastatic carcinoma of digestive system.
- Conditions
- Targeted Therapy, HER2, Biliary Tract Cancer, Esophageal Squamous Cell Carcinoma, Colorectal Cancer
- Being tested
- chemotherapy in combination with trastuzumab for arm1, chemotherapy in combination with trastuzumab for arm2, chemotherapy in combination with trastuzumab for arm3, chemotherapy in combination with trastuzumab for arm4
- Keywords
- Human epidermal growth factor receptor 2, Biliary tract cancer, Esophageal squamous cell carcinoma, Targeted therapy, colorectal cancer
- Medical subject headings
- Biliary Tract Neoplasms, Esophageal Squamous Cell Carcinoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy in combination with trastuzumab for arm1Drug
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)
chemotherapy in combination with trastuzumab for arm2Drug
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.
chemotherapy in combination with trastuzumab for arm3Drug
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.
chemotherapy in combination with trastuzumab for arm4Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| GI tumor beyond CRC, ESCC, BTC,GC&GEJA | Experimental | HER2 positive GI tumor beyond CRC, ESCC, BTC,GC\&GEJA Receives: Drug: chemotherapy in combination with trastuzumab for arm1 |
| Esophageal squamous cell carcinoma | Experimental | HER2 positive Esophageal squamous cell carcinoma Receives: Drug: chemotherapy in combination with trastuzumab for arm2 |
| Biliary tract cancer | Experimental | HER2 positive Biliary tract cancer Receives: Drug: chemotherapy in combination with trastuzumab for arm3 |
| Colorectal cancer | Experimental | HER2 positive and RAS/BRAF wild type colorectal cancer Receives: Drug: chemotherapy in combination with trastuzumab for arm4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
Secondary outcomes (9)
Disease control rate
The percentage of patients who achieve complete remission(CR) or partial remission (PR) or stable disease(SD) determined by the RECIST v1.1 criteria.
Measured: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
best overall response
The percentage of patients who achieve either a CR or PR as determined by the RECIST v1.1 criteria based on investigator's assessment that is confirmed by a repeat assessment performed no less than 4 weeks after the criteria for response are first met.
Measured: 10-30 weeks
Progression free survival
Defined as the initiation of treatment to the day of first documentation of PD or date of death, whichever occurs first.
Measured: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
Overall survival
Is the time from the initiation of treatment to the date of death from any cause.
Measured: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
time to response
Defined as the initiation of treatment to the day of first documentation of response.
Only patients who achieve an objective response will be included in the analysis.
Measured: 6-30 weeks
duration of response
Defined as the time from the date of the first documented objective response to the date of first documented PD or death, whichever occurs first. Only patients who achieve an objective response will be included in the analysis.
Measured: 6-30 weeks
time to progression(TTP)
Defined as the initiation of treatment to the day of first documentation of PD.
Measured: 6-30 weeks
Quality of Life by Eastern Cooperative Oncology Group(ECOG)performance status( PS) scoring criteria
Measured: Day 1 of each 21-day treatment cycle up to 28 days and 60-90 days after Day 1 of last treatment cycle(up to approximately 8.5 years)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: baseline up to approximately 8.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Jul 2017
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Targeted TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, Master, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185988
- Sponsor's protocol ID
- CGOG2006
- Status last verified
- Jul 2019
- First submitted
- 16 May 2017
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36550683
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Phase II Study of Chemotherapy in Combination With Trastuzumab in Patients of Pretreated, HER2 Positive, Relapse or Metastatic Carcinoma of Digestive System
- ClinicalTrials.gov ID
- NCT03185988
- Acronym / sponsor ID
- CGOG2006
- Conditions
- Targeted Therapy, HER2, Biliary Tract Cancer, Esophageal Squamous Cell Carcinoma, Colorectal Cancer
- Keywords
- Human epidermal growth factor receptor 2, Biliary tract cancer, Esophageal squamous cell carcinoma, Targeted therapy, colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shen LinUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Human epidermal growth factor receptor 2, (HER2) is overexpressed /amplified in multiple carcinomas, for example, gastric cancer(GC), gastroesophageal junction adenocarcinoma(GEJA),and breast cancer.And HER2 is closely related to tumor proliferation \&metastases.About 90% Chinese esophagus cancer are squamous cell origin. The reported HER2 overexpression ranged from 5-30%, Beijing cancer hospital reported an 11% positive rate. The variety of HER2 positive rate may because of the absence of standard HER2 testing criteria. The current treatment for metastatic Esophageal squamous Cell Carcinoma (ESCC) is not satisfactory. Fluorouracil and platinum are considered as first line standard of care (SOC) with a 20-30% RR and 7-9 months overall survival (OS). In second line setting, there is no SOC in china. And the efficacy is not satisfactory. Esophageal adenocarcinoma has a higher HER2 positive rate of 14%, but no data reported of using trastuzumab in these patients in China. Biliary tract cancer (BTC), including intrahepatic/extrahepatic cholangiocarcinoma and Gallbladder cancer (GBC) is very aggressive, total 5y survival is less than 5% for unresectable patients. GBC is account for approximately 2/3 of BTC, and it's estimated the incidence in china is 52800 and the mortality is 40700 in 2015. Most patients are diagnosed in advanced stage and lose the opportunity of surgery. However, there is no SOC for unresectable BTC, gemcitabine plus platinum provided a 30% RR and 10 month OS. In second line treatment, no differences were seen between various experimental agents. The reported HER2 positive rate range from 5.1% to 57% in biliary duct cancer and 4.7% to 64% in GBC. Researchers reported her2 amplification is related to tumor stage and lymph nodes metastasis in 221 BTC patients. Another study reported a 16.6% positive rate and worse prognosis with a sample size of 230 GBC patients. Meanwhile, HER2 pathway mutation rate reached 37%. All imply that BTC may be the potential anti HER therapy population. Besides, other digestive system tumor has low HER2 positive rate (Small intestinal cancer 0.9-3%; hepatocellular carcinoma 2.4%; Pancreatic cancer 3%; etc.). However, the patient pool is large and has no SOC in second Line. Whether these HER2 + patients can gain benefit form anti- her treatment is worth investigating. In 2016 American Society of Clinical Oncology (ASCO), a study reported that using trastuzumab and pertuzumab combination, 35% metastatic colorectal cancer (CRC) and 50% BTC patients who heavily pretreated had objective response. However, china doesn't have studies for these patients. .
The concurrent basket trial will explore the efficacy and safety of trastuzumab with chemotherapy in Chinese patients of pretreated, HER2 positive, relapse or metastatic carcinoma of digestive system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GI tumor beyond CRC, ESCC, BTC,GC&GEJA | Experimental | Drug: chemotherapy in combination with trastuzumab for arm1HER2 positive GI tumor beyond CRC, ESCC, BTC,GC\&GEJA |
| Esophageal squamous cell carcinoma | Experimental | Drug: chemotherapy in combination with trastuzumab for arm2HER2 positive Esophageal squamous cell carcinoma |
| Biliary tract cancer | Experimental | Drug: chemotherapy in combination with trastuzumab for arm3HER2 positive Biliary tract cancer |
| Colorectal cancer | Experimental | Drug: chemotherapy in combination with trastuzumab for arm4HER2 positive and RAS/BRAF wild type colorectal cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signed informed consent.
- Male and female patients aged from 18 to 75 years
- Histologically confirmed Colorectal cancer,Esophagus squamous cell carcinoma, biliary tract cancer, and digestive system tumor beyond CRC and GC\&GEJA with the following specifications:
- If able to reproduce, patients must be willing to use highly effective methods of contraception during treatment and for 7 months after the end of treatment.
Key exclusion criteria (22 listed)
- Known hypersensitivity against treatment regimen.
- Baseline left ventricular ejection fraction(LVEF) < 50% (measured by echocardiography or MUGA).
- Previous anti-her treatment.
- Immune therapy, biological therapy or any participation in clinical trial in previous two weeks.
- Surgery and not recovered in previous three weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy in combination with trastuzumab for arm1Arm1: 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) | Drug | GI tumor beyond CRC, ESCC, BTC,GC&GEJA |
| chemotherapy in combination with trastuzumab for arm2Arm2: 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. | Drug | Esophageal squamous cell carcinoma |
| chemotherapy in combination with trastuzumab for arm3Arm 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. | Drug | Biliary tract cancer |
| chemotherapy in combination with trastuzumab for arm4Trastuzumab (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) | Drug | Colorectal cancer |
Primary outcome
Response Rate(RR) for each cohort in intent to treat (ITT) population
Time frame: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
The percentage of patients, whose tumor volume in first time shrink to pre-defined criteria, including CR and PR
9 secondary outcomes
Disease control rate
Time frame: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
best overall response
Time frame: 10-30 weeks
Progression free survival
Time frame: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
Overall survival
Time frame: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)
time to response
Time frame: 6-30 weeks
duration of response
Time frame: 6-30 weeks
time to progression(TTP)
Time frame: 6-30 weeks
Quality of Life by Eastern Cooperative Oncology Group(ECOG)performance status( PS) scoring criteria
Time frame: Day 1 of each 21-day treatment cycle up to 28 days and 60-90 days after Day 1 of last treatment cycle(up to approximately 8.5 years)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: baseline up to approximately 8.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Derived from this study: PubMed 36550683Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen, Master principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy in combination with trastuzumab for arm1, chemotherapy in combination with trastuzumab for arm2 and chemotherapy in combination with trastuzumab for arm3 in people with Targeted Therapy and HER2, run by Shen Lin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xicheng Wang, Dr. (86-10-8819-6561, xicheng_wang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate(RR) for each cohort in intent to treat (ITT) population (time frame: baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.