Status:
UNKNOWN
Neoadjuvant FOLFOXIRI Chemotherapy in Resectable Liver Metastasis of Colorectal Cancer
Lead Sponsor:
China Medical University, China
Conditions:
Colorectal Neoplasms
Drug Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with resectable liver metastasis of colorectal cancer
Detailed Description
For the patients Neoadjuvant FOLFOX chemotherapy is recommended for the resectable liver metastasis colorectal cancer. Neoadjuvant chemotherapy could suppress tumor, reduce metastasis, inhibit recurre...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03487939
Start Date
May 1 2018
End Date
October 1 2021
Last Update
April 19 2021
Active Locations (1)
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1
Liaoning cancer hospital
Shenyang, Liaoning, China, 110000