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

NCT ID: NCT04521491

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FOLFOX4

Patients who will receive FOLFOX4 chemotherapy after liver resection

Group Type: EXPERIMENTAL

FOLFOX4(infusional fluorouracil [FU], leucovorin [LV], and oxaliplatin [OXA]).

Intervention Type: DRUG

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.

placebo

No adjuvant therapy after liver resection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shen Feng

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EHBHKY2020-01-003

Identifier Type: -

Identifier Source: org_study_id