NCT04521491

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

August 19, 2020

Last Update Submit

August 19, 2020

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomaadjuvant therapyFOLFOX4circulating tumor cellsfolate receptor

Outcome Measures

Primary Outcomes (1)

  • Recurrence free survival(RFS)

    the time from randomization to documented progression

    Up to 2 years

Secondary Outcomes (2)

  • Time to recurrence (TTR)

    Up to 2 years

  • Overall survival(OS)

    Up to 2 years

Study Arms (2)

FOLFOX4

EXPERIMENTAL

Patients who will receive FOLFOX4 chemotherapy after liver resection

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

placebo

NO INTERVENTION

No adjuvant therapy after liver resection

Interventions

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

FOLFOX4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularNeoplastic Cells, Circulating

Interventions

LeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 20, 2020

Study Start

December 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations

CN(1)