Clinical trial · Interventional
A Trial of Adjuvant Therapy After Hepatocarcinoma Resection Based on Folate Receptor-positive Circulating Tumor Cells
A Randomized Controlled Study on the Effect of Postoperative Adjuvant Chemotherapy With FOLFOX4 After Hepatocarcinoma Resection Based on Folate Receptor-positive Circulating Tumor Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX4(infusional fluorouracil [FU], leucovorin [LV], and oxaliplatin [OXA]). | Drug | FOLFOX-4 Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFOX4
- description
- Patients who will receive FOLFOX4 chemotherapy after liver resection
- interventionNames
- Drug: FOLFOX4(infusional fluorouracil [FU], leucovorin [LV], and oxaliplatin [OXA]).
- type
- NO_INTERVENTION
- label
- placebo
- description
- No adjuvant therapy after liver resection
Primary outcomes (1)
- measure
- Recurrence free survival(RFS)
- timeFrame
- Up to 2 years
- description
- the time from randomization to documented progression
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available