Trial · NCT00183885
A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma
NCT00183885, Phase 2, Completed, University of Southern California; results first posted 2025-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma. Trials, record NCT00183885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00183885
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma
- NCT number
- NCT00183885
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Interventions
- mitomycin-c, cisplatin
- First posted
- 2005-09-16
- Last updated
- 2025-10-30
- Results first posted
- 2025-10-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response | Up to 2 years | A modified Response Evaluation Criteria In Solid Tumors (RECIST) will be used. The modification to RECIST is that although all lesions will be followed, only the treated lesions will be included in the assessment of response. Additionally, all lesions will be evaluated according to the following criteria: Presence of arterial enhancement: Yes or No. Complete Response (CR) = Absence of enhancing tumor areas, reflecting complete tissue necrosis. Partial Response (PR) = A decrease \> 50% of enhanced areas, reflecting partial tissue necrosis. Stable Disease (SD) = A tumor response between PR and PD. Progression (PD) = An increase \> 25% in the size of \> 1 measurable lesion(s) or the appearance of new lesions in the treated area (ie, specific segment or lobe of liver targeted by the intra-arterial infusion). |
| Secondary | Number of Participants With Grade 3 or Higher Toxicity | Up to 1 year | Toxicity will be assessed according to CTCAE version 3.0 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response | Up to 2 years | Patients with measurable tumor who complete one cycle, or who terminate treatment for reasons of toxicity, or who progress prior to completion of one cycle, will be included in analysis of tumor response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or Higher Toxicity | Up to 1 year | All eligible patients who begin treatment are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response | Cisplatin + Mitomycin-C | CR | 0 | Participants | |
| Tumor Response | Cisplatin + Mitomycin-C | PR | 7 | Participants | |
| Tumor Response | Cisplatin + Mitomycin-C | SD | 47 | Participants | |
| Tumor Response | Cisplatin + Mitomycin-C | PD | 11 | Participants | |
| Tumor Response | Cisplatin + Mitomycin-C | Inevaluable for Response | 11 | Participants | |
| Number of Participants With Grade 3 or Higher Toxicity | Cisplatin + Mitomycin-C | 75 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cisplatin + Mitomycin-C | 76 | |
| Overall Study | COMPLETED | Cisplatin + Mitomycin-C | 37 | |
| Overall Study | NOT COMPLETED | Cisplatin + Mitomycin-C | 39 |
Source ClinicalTrials.gov
Adverse events101
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hearing impaired | Ear and labyrinth disorders | Cisplatin + Mitomycin-C | 1 | 76 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Cisplatin + Mitomycin-C | 3 | 76 | 4 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Cisplatin + Mitomycin-C | 60 | 76 | 119 |
| other | Leukocytes (total WBC) decreased | Blood and lymphatic system disorders | Cisplatin + Mitomycin-C | 3 | 76 | 5 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Cisplatin + Mitomycin-C | 17 | 76 | 47 |
| other | Platelets decreased | Blood and lymphatic system disorders | Cisplatin + Mitomycin-C | 39 | 76 | 96 |
| other | Hypertension | Cardiac disorders | Cisplatin + Mitomycin-C | 1 | 76 | 1 |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Cisplatin + Mitomycin-C | 53 | 76 | 97 |
| other | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | Gastrointestinal disorders | Cisplatin + Mitomycin-C | 6 | 76 | 8 |
| other | Insomnia | General disorders | Cisplatin + Mitomycin-C | 2 | 76 | 3 |
1 to 10 of 101Source ClinicalTrials.gov
See all 101 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cisplatin + Mitomycin-C | 44 | 76 |
| Total, other adverse events | Cisplatin + Mitomycin-C | 75 | 76 |
| Total, serious adverse events | Cisplatin + Mitomycin-C | 51 | 76 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00183885
GET https://conductscience.org/api/trials/v1/NCT00183885/events?page=2