Trial · NCT04478292
A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
NCT04478292, Phase 3, Recruiting, Shanghai Children's Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy. Trials, record NCT04478292. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04478292
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
- NCT number
- NCT04478292
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 330 participants, estimated
- Lead sponsor
- Shanghai Children's Medical Center
- Conditions
- Hepatoblastoma
- Interventions
Sodium Thiosulfate Injection, Primary surgery resection, mono CDDP-Group A2, Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C, Biopsy, Resection or transplant, Resection of pulmonary nodules, mono CDDP- Group B, Block 1 to 3 (Cisplatin, Doxorubicin) Group D, Consolidation (Carboplatin, Doxorubicin) -Group D1, Consolidation (Carboplatin +Doxorubicin/Vincristine + Irinotecan)-Group D2
- First posted
- 2020-07-20
- Last updated
- 2026-05-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Audiogram | From diagnosis through study completion, an average of 1 year | The grade (from 0 to 4, higher scores mean a worse outcome) of audiograms evaluated by Boston Grading Scale for Ototoxicity.To evaluate and validate the efficacy of sodium thiosulfate (STS) to reduce the hearing impairment caused by a cisplatin monotherapy in non- metastatic patients without adverse features (localized PRETEXT I-III tumors without positive VPEFR annotation factors) (Group B - treated with cisplatin mono-therapy) or with adverse features (localized PRETEXT I-III tumors with positive VPEFR annotation factors) (Group C - treated with regimen C5VD). |
| Primary | 3 -year Event-free survival (EFS) | UP to 3years | Calculated from the time of randomisation to the first of the following events: progression, relapse, secondary malignancy or death. |
| Secondary | Treatment-related adverse events | UP to 3years | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 |
| Secondary | Response to chemotherapy | UP to 3years | Complete response (CR): no evidence of disease and normal serum AFP value (for age). Partial response (PR): any tumour volume shrinkage associated with a decreasing serum AFP value, \> 1 log below the original measurement. Stable disease (SD): no tumour volume change and no change, or \< 1 log fall of the serum AFP concentration. Progressive disease (PD): unequivocal increase in 1 or more dimensions and/or any unequivocal increase of the serum AFP concentration (three successive 1-2 weekly determinations) even without clinical (physical and/or radiological) evidence of tumour re-growth. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT04478292
GET https://conductscience.org/api/trials/v1/NCT04478292/registered