Systemic Chemotherapy Plus HAI(FUDR）vs Systemic Chemotherapy Alone For CRCLM

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the trial is to optimize the overall survival of patients with resectable colorectal liver metastasis who have undergone liver metastasis resection. The patients will be treated with systemic chemotherapy plus hepatic arterial infusion With floxuridine, or with systemic chemotherapy only

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Floxuridine; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

1. Age: 18-75 years old

2. Histologically confirmed colorectal adenocarcinoma

3. Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis

4. besides systematic chemotherapy，with no prior treatment for liver metastasis, including operation, radiotherapy,HAI, transcatheter hepatic arterial chemoembolization (TACE) and ablation.

5. Without extra-hepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) scanning

6. With adequate bone marrow function: platelets ≥ 90 x 109/L; white blood cells ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L Serum bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN

7. Patient has no ascites and with adequate blood coagulation function, albumin ≥ 35 g/L

8. Grade A level of Child-Push Liver Function

9. Creatinine ≤ 1× ULN, or Calculated Creatinine Clearance >50ml/min （Cockcroft-Gault Equation）

10. ECOG performance status of 0-2

11. Life expectancy ≥ 3 months

12. Not appropriate for anti-EGFR or any other targeted therapy (with KRAS mutation or could not afford it)

13. Patients have provided a signed Informed Consent Form

14. With good compliance

Exclusion Criteria:

1. With any extra-hepatic metastasis and/or primary tumor recurrence

2. Severe arterial embolism or ascites

3. With hemorrhagic tendency or coagulation disorders

4. Hypertensive crisis or hypertensive encephalopathy

5. Severe and uncontrolled systemic complications such as infections or diabetes.

6. Serious cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension even with appropriate drug intervention, unstable angina pectoris, congestive heart failure (NYHA 2-4 degree), arrhythmia that needs medication intervention

7. Patient who has suffered from central nervous system diseases such as primary brain tumor, uncontrolled epilepsy even with standard treatment, any brain metastasis or stroke

8. Patient who has a concurrent malignancy or has a malignancy within 5 years before study enrollment, (with the exception of radically resected skin basal cell carcinoma or cervical carcinoma in situ)

9. Patient who has received any investigational antineoplastic agent within 28 days before the enrollment

10. Any residual toxicity from prior chemotherapy (with the exception of alopecia), such as grade 2 or more sensory peripheral neuropathy (NCI CTC v3.0), oxaliplatin-based regimen will not be considered

11. Patient who is allergic to oxaliplatin, leucovorin, 5-Fluorouracil, floxuridine or dexamethasone

12. Pregnant or lactating women

13. Patient who does not use or refuses to take any appropriate contraceptive measures (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or sterilization operation), including women of childbearing age (within 2 years after the last menstrual period) and men who are with possible fertility

14. Unable or unwilling to comply with the research plan

15. The existence of any other disease, dysfunction caused by metastatic lesions, or suspicious disease found on the regular examination, which indicating contraindications to the use of study drugs or may bring high risks of treatment related complications