Adjuvant Systemic Chemotherapy With or Without HAI-FUDR in Patients With Resected CRLM

Last updated: January 19, 2024
Sponsor: Sun Yat-sen University
Overall Status: Terminated

Phase

3

Condition

Neoplasm Metastasis

Liver Metastases

Rectal Cancer

Treatment

FUDR

Irinotecan

Leucovorin

Clinical Study ID

NCT03500874
HAI-CRCLM-ADJUVANT
  • Ages 18-75
  • All Genders

Study Summary

HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The primary lesion has undergone or is capable of radical resection, and livermetastases can undergo R0/R1 resection (including intraoperative interventionalablation therapy), and postoperative achievement of no evidence of disease (NED).
  2. Histologically confirmed colorectal adenocarcinoma
  3. Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis
  4. No previous surgery, interventional ablation, hepatic arterial infusion (HAI),radiotherapy, or transarterial chemoembolization (TACE) for liver metastases.
  5. CT, MRI, or PET/CT (if necessary) confirmed no extrahepatic metastasis.
  6. Normal hematologic function (platelets > 90×10^9/L; white blood cells > 3×10^9/L;neutrophils > 1.5×10^9/L).
  7. No ascites, normal coagulation function, albumin ≥ 35g/L.
  8. Liver function graded as Child-Pugh class A.
  9. Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminases ≤ 5 timesULN, alkaline phosphatase ≤ 2.5 ULN.
  10. Serum creatinine below the upper limit of normal (ULN), or calculated creatinineclearance > 50ml/min (using Cockcroft-Gault formula).
  11. ECOG performance status of 0-2
  12. Life expectancy ≥ 3 months
  13. Patients have provided a signed Informed Consent Form
  14. Willing and able to undergo follow-up until death or the end of the study or studytermination.

Exclusion

Exclusion Criteria:

  1. Have had any extrahepatic metastasis after being diagnosed with colorectal cancer.
  2. Previous surgery, interventional ablation, hepatic arterial infusion (HAI),radiotherapy, or transarterial chemoembolization (TACE) for liver metastases.
  3. Liver metastases intended for interventional ablation treatment only.
  4. Presence of hepatic artery vascular variation identified by CTA examination, makingHAI implantation unsuitable.
  5. Severe arterial embolism or ascites.
  6. Bleeding tendency or coagulation disorders.
  7. Hypertensive crisis or hypertensive encephalopathy.
  8. Severe uncontrollable systemic complications such as infection or diabetes.
  9. Clinically significant cardiovascular diseases such as cerebrovascular accidents (inthe last 6 months before enrollment), myocardial infarction (in the last 6 monthsbefore enrollment), uncontrolled hypertension despite appropriate drug treatment,unstable angina, congestive heart failure (NYHA 2-4), and arrhythmias requiringmedication.
  10. History of or physical examination indicating central nervous system diseases (such asprimary brain tumors, uncontrollable epilepsy, any brain metastasis, or history ofstroke).
  11. Had any other malignant tumors in the past 5 years (excluding basal cell carcinomaand/or cervical carcinoma in situ after radical surgery).
  12. Received any investigational drug treatment in the last 28 days before the study.
  13. Any residual toxicity from previous chemotherapy (excluding alopecia), such asperipheral neuropathy ≥ NCI CTC v3.0 grade 2, makes the use of a treatment regimencontaining oxaliplatin not considered.
  14. Allergic to any drugs in the study.
  15. Pregnant or lactating women who are not using or refuse to use effective non-hormonalcontraception (intrauterine device, barrier contraception combined with spermicidalgel, or sterilization) in women of childbearing age (last menstrual period < 2 yearsago) or fertile men who cannot or do not wish to comply with the study protocol.
  16. Presence of any other diseases, functional impairment due to metastatic lesions, orsuspicious findings in the physical examination suggesting contraindications to theuse of the investigational drug or placing the patient at a high risk oftreatment-related complications.

Study Design

Total Participants: 92
Treatment Group(s): 5
Primary Treatment: FUDR
Phase: 3
Study Start date:
May 28, 2018
Estimated Completion Date:
August 31, 2021

Study Description

Numerous retrospective studies have indicated a positive synergistic effect of combining adjuvant oxaliplatin/irinotecan-based doublet systemic chemotherapy and hepatic arterial infusion (HAI) for colorectal cancer (CRC) patients following colorectal cancer liver metastases (CRLM) resection. However, this strategy has not been evaluated prospectively to date. HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

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