Clinical trial · Interventional
Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)
NCT00464295CI-TRIAL-00001021HCC-CAPcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
In patients with unresectable/advanced Hepatocellular Carcinoma receiving Capecitabin, we anticipate that the proposed chemotherapy will have a delay in progression of the disease . It is also expected that proposed chemotherapy will have acceptable toxicity and Quality of life.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine in HCC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate response rate and overall survival after completing minimum of three cycles of Capecitabine in Advance HCC
- timeFrame
- 12 months from the start of chemotherapy
Secondary outcomes (1)
- measure
- To evaluate the time to progression, toxicity and quality of life for patients on chemotherapy
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Age between 18 and 70 years. * Documented by at least 2 out of three mentioned criteria and evidence of non-resectability. 1. Radiological either CT Scan/US abdomen 2. Biopsy, 3. Serum alphafeto protein level * Multi centric hepatoma or TNM Classification Stage IV. * Child's class B or C with a Child's score of maximum 11. * No other active malignancy except localized basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * Life expectancy of greater then 3 months. * Current laboratory values must be within the limits listed below: Haemoglobin \> 8 g/dL WBC \> 4,000/uL Absolute Neutrophil Count \> 1,500/uL Platelets \> 75,000/uL * ECOG Performance status of \< 2. * Patients who have received adjuvant or neoadjuvant therapy are eligible. A minimum interval of 4 weeks since last chemotherapy will be required. * Prior radiotherapy will be allowed if it did not involve a site used to assess response and 4 weeks have elapsed since completion of radiotherapy. Exclusion Criteria: * History of allergic reaction to compound chemically related to CAP. * Concomitant or previous malignancies within five years other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix. * Active, uncontrolled infection. . * Concurrent medical problems which could limit the life expectancy or the ability of the patient to receive chemotherapy. * Mental condition that could limit the patient in comprehending the concept of clinical trial or complying with its requirements. * Brain or leptomeningeal involvement. * Pre-existing neurotoxicity of \>=grade 2. * Concomitant radiotherapy, unless localised for bone pain control or palliation. * Being of reproductive potential and not agreeing to practice an effective contraceptive method. * Pregnancy or lactation. * Severe renal impairment with Creatinine clearance \<30ml/minute. * Documented Cardiomyopathy or severe coronary artery disease, or history of arrhythmias.
References
Publications (0)
Data not yet available
No reference posted for this study.