Colorectal Cancer Clinical Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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. - 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. Exclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Shen Lin |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | 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. | baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years) | |
Secondary | 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. | 10-30 weeks | |
Secondary | Progression free survival | Defined as the initiation of treatment to the day of first documentation of PD or date of death, whichever occurs first. | baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years) | |
Secondary | Overall survival | Is the time from the initiation of treatment to the date of death from any cause. | baseline up to death or disease progression,which ever occurs first(up to approximately 8.5 years) | |
Secondary | 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. |
6-30 weeks | |
Secondary | 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. | 6-30 weeks | |
Secondary | time to progression(TTP) | Defined as the initiation of treatment to the day of first documentation of PD. | 6-30 weeks | |
Secondary | Quality of Life by Eastern Cooperative Oncology Group(ECOG)performance status( PS) scoring criteria | 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) | ||
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | baseline up to approximately 8.5 years |
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