A Trial of Adjuvant Therapy After Hepatocarcinoma Resection Based on Folate Receptor-positive Circulating Tumor Cells

August 19, 2020 updated by: Shen Feng, Eastern Hepatobiliary Surgery Hospital

A Randomized Controlled Study on the Effect of Postoperative Adjuvant Chemotherapy With FOLFOX4 After Hepatocarcinoma Resection Based on Folate Receptor-positive Circulating Tumor Cells

The aim of this study is to analyze the therapeutic effect of postoperative adjuvant chemotherapy with FOLFOX4 after hepatocarcinoma resection based on folate receptor-positive circulating tumor cells. Patients receiving curative resection (R0) were randomized to postoperative FOLFOX4 group and no FOLFOX4 group. The time to recurrence, the overall survival as well as the incidence of complications after therapy was observed to confirm the role of postoperative adjuvant therapy of FOLFOX4.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is the third leading cause of cancer death globally. Hepatectomy remains the most widely practiced radical treatment for HCC despite having a high associated recurrence rate, approximately 70% at 5 years after surgery, which often hampers further improvement in survival for these patients. And until now although a lot of different adjuvant therapies had been tried in the clinic, but their role in preventing recurrence remain controversial. As a research of a phase Ⅲ randomize study showed that FOLFOX4 (infusional fluorouracil [FU], leucovorin[LV], and OXA) served as palliative chemotherapy can induce higher overall survival, progression-free survival and response rate comparing to doxorubicin in patients with advanced hepatocellular carcinoma from Asia. The safety data was also acceptable. The chemotherapy of FOLFOX has been accepted by many guidelines and recommended for systematic treatment of advanced HCC. However, the effect of this systemic chemotherapy for recurrent HCC after partial hepatectomy remains to be investigated.

Circulating tumor cells (CTC) have played an important role in early diagnosis of tumors, monitoring of recurrence and metastasis, judgment of patient prognosis, and guidance of postoperative adjuvant treatment. CTC counts can be used to assist diagnosis and evaluation of postoperative prognosis. Previous studies have also shown that folate receptors (FR) are highly expressed in HCC. The detection of circulating tumor cells based on folate receptor (FR+CTC) has been proved to be a sensitive and effective method for detecting CTC.

Patients with HCC who received curative liver resection and with the preoperative FR+CTC level higher than 18.4FU/3mL were randomly assigned 1:1 by the doctors to receive placebo(control group) or FOLFOX4 (treatment group). All patients in the treatment group received FOLFOX4 at most 12 cycles beginning from the 4th week after liver resection. The outcomes of patients were evaluated during the 3-years follow up.

Study Type

Interventional

Enrollment (Anticipated)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with HCC who received curative liver resection (R0);
  2. Karnofsky Performance Score performance over 60;
  3. The functions of the kidney, heart and lung and the blood system are normal and fittable for Licardin therapy;
  4. The liver function is of grade A or B in Child-Pugh classification;
  5. Patients agreed to collect peripheral blood for detection of CTC at the designated time point;
  6. Patients should sign the informed consent of this study.

Exclusion Criteria:

  1. If postoperative liver function is Child C, it cannot tolerate chemotherapy;
  2. Blood transfusion history within 1 month before enrollment;
  3. Severe gastroesophagealvarices with red sign or with variceal hemorrhage before;
  4. Malignant or metastatic tumor in other sites in last 5 years;
  5. Patients can not be followed-up regularly;
  6. Patients participating in other trials or received other treatment previously.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FOLFOX4
Patients who will receive FOLFOX4 chemotherapy after liver resection
Drug: FOLFOX4(infusional fluorouracil [FU], leucovorin [LV], and oxaliplatin [OXA]).
FOLFOX4 (OXA 85 mg/m2 intravenously [IV] on day 1; LV 200 mg/m2 IV from hour 0 to 2 on days 1 and 2; and FU 400 mg/m2 IV bolus at hour 2, then 600 mg/m2 over 22 hours on days 1 and 2, once every 2 weeks.All patients in the treatment group will receive FOLFOX4 at most 12 times beginning from the 4th week after liver resection.
No Intervention: placebo
No adjuvant therapy after liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival(RFS)
Time Frame: Up to 2 years
the time from randomization to documented progression
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recurrence (TTR)
Time Frame: Up to 2 years
the time from randomization to documented progression
Up to 2 years
Overall survival(OS)
Time Frame: Up to 2 years
the time from randomization to documented progression
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBHKY2020-01-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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