Colorectal Neoplasms Clinical Trial
Official title:
Neoadjuvant FOLFOXIRI Chemotherapy in Resectable Liver Metastasis of Colorectal Cancer:an Open-label, Single-arm, Multicenter Phase II Study
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with resectable liver metastasis of colorectal cancer
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria - Age: 18-75years old - Histologically confirmed colorectal cancer with liver metastasis (all patients should have the pathological report of colorectal cancer). The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. - It was confirmed by imaging that the liver metastases and the primary intestinal lesions were all resectable. - Radical resection of colorectal cancer after adjuvant chemotherapy complete 1 years later with liver metastases. - There is at least one measurable objective tumor of the tumor (according to the 1.1 version of RECIST standard). - Liver metastases can be excised by R0 and sufficient normal liver tissue can be retained - ECOG status: 0~1 - Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count=1.5×10^9/L Platelet count=90×10^9/L Hemoglobin=90g/L Total bilirubin (TBI) = 1.5 * ULN Alanine aminotransferase (ALT)=2.5 * ULN Aspartate aminotransferase (AST)=2.5 * ULN Alkaline phosphatase (ALP)=2.5 * ULN - Signed informed consent; able to comply with study and/or follow- up procedures Exclusion Criteria: - Hypersensitivity to fluorouracil, oxaliplatin or irinotecan. - In addition to liver metastases, there are other parts of metastasis - Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; Active ischemic heart disease; Myocardial infarction within the past 6 months; Symptomatic arrhythmia Uncontrolled hypertension. Unexplained syncope occurred within 3 months - Gastric ulcers or duodenal ulcers for the treatment of resistance; - 3 or 4 grade gastrointestinal bleeding / bleeding; - Gastrointestinal perforation / fistula; - Abdominal abscess; - Infectious or inflammatory bowel disease - HIV infection and/or active hepatitis B virus infection - Pregnant or lactating women. Fertile patients must use effective contraception - Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study - Other intervention clinical trials were combined at the same time. - Nerve or mental abnormality affecting cognitive ability - Other malignancy except effectively treated squamous cell or basal cell skin cancer, - Other situations that the researchers think should be excluded. |
Country | Name | City | State |
---|---|---|---|
China | Liaoning cancer hospital | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
China Medical University, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The ratio of tumor downstaging to stage 0 and stage I | Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I | 2 years | |
Secondary | Tumor regression grade (TRG) | The level of tumor regression under pathological examination | 2 years | |
Secondary | Disease free survival | Estimated from the date of surgery to the date of recurrence. | 3 years | |
Secondary | Overall survival time | Estimated from the date of enrollment to death from any cause. | 3 years | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The grade of toxicity will be assessed using the NCI-CTCAE version 4.0. | 3 years | |
Secondary | ctDNA assessment and relation to clinical outcome | The relationship between ctDNA and survival will be evaluated. | 3 years | |
Secondary | SUVmax assessment and relation to clinical outcome | Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy | At the beginning of Cycle 1 and the end of Cycle 4 (each cycle is 14 days) | |
Secondary | Quality of life (QLQ C30) | Scores according to EORTC QLQ-C30 scoring manual | Every 2 weeks after the first treatment until 3 years |
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