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GROUP D1 for Hepatoblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sinai Hospital of Baltimore, Baltimore, MDHepatoblastoma+4 MoreCisplatin - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a combination of cisplatin and other drugs as a possible treatment for hepatoblastoma or hepatocellular carcinoma.

Eligible Conditions
  • Hepatoblastoma
  • Childhood Hepatocellular Carcinoma
  • Childhood Liver Cancer
  • Fibrolamellar Carcinoma
  • Liver Cancer, Not Otherwise Specified

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Phase 1: Arm A: CFT1946
2
Carboplatin
1
Capecitabine

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Up to 5 years

3 years
Event-free survival (EFS)
Failure free survival
Overall survival
6 months
Percentage of Group B2 participants with resectable tumors
8 months
Percentage of patients experiencing grade 3 or higher adverse events
Up to 5 years
Best response
Percentage of participants who are surgically resectable
Percentage of participants with adherence to surgical guidelines
Percentage of patients with chemotherapy-related cardiac, nephro- and oto-toxicity
Percentage of patients with hearing loss
Response rate for Group F patients

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Phase 1: Arm A: CFT1946
3
Carboplatin
2
Capecitabine

Trial Design

16 Treatment Groups

GROUP E1
1 of 16
Group A1 (WDF)
1 of 16
GROUP D1
1 of 16
GROUP D2 ARM CE
1 of 16
GROUP B2 (UNRESECTABLE)
1 of 16
GROUP D2 ARM VI
1 of 16
GROUP E2 (PLADO)
1 of 16
GROUP F ARM 1 (PLADO)
1 of 16
GROUP F ARM 2 (P/GEMOX)
1 of 16
GROUP A2 (NON-WDF)
1 of 16
GROUP B1 ARM 4-CDDP
1 of 16
GROUP B1 ARM 6-CDDP
1 of 16
GROUP B2 ARM I
1 of 16
GROUP B2 ARM II
1 of 16
GROUP C ARM C5VD
1 of 16
GROUP C ARM CDDP
1 of 16

Active Control

Experimental Treatment

537 Total Participants · 16 Treatment Groups

Primary Treatment: GROUP D1 · No Placebo Group · Phase 2 & 3

GROUP D1Experimental Group · 4 Interventions: Cisplatin, Doxorubicin, Laboratory Biomarker Analysis, Carboplatin · Intervention Types: Drug, Drug, Other, Drug
GROUP D2 ARM CEExperimental Group · 5 Interventions: Cisplatin, Doxorubicin, Etoposide, Laboratory Biomarker Analysis, Carboplatin · Intervention Types: Drug, Drug, Drug, Other, Drug
GROUP B2 (UNRESECTABLE)Experimental Group · 2 Interventions: Cisplatin, Laboratory Biomarker Analysis · Intervention Types: Drug, Other
GROUP D2 ARM VIExperimental Group · 6 Interventions: Cisplatin, Doxorubicin, Irinotecan, Vincristine Sulfate, Laboratory Biomarker Analysis, Carboplatin · Intervention Types: Drug, Drug, Drug, Drug, Other, Drug
GROUP E2 (PLADO)Experimental Group · 3 Interventions: Cisplatin, Doxorubicin, Laboratory Biomarker Analysis · Intervention Types: Drug, Drug, Other
GROUP F ARM 1 (PLADO)Experimental Group · 4 Interventions: Cisplatin, Doxorubicin, Sorafenib, Laboratory Biomarker Analysis · Intervention Types: Drug, Drug, Drug, Other
GROUP F ARM 2 (P/GEMOX)Experimental Group · 7 Interventions: Cisplatin, Doxorubicin, Resection, Sorafenib, Gemcitabine, Laboratory Biomarker Analysis, Oxaliplatin · Intervention Types: Drug, Drug, Procedure, Drug, Drug, Other, Drug
GROUP A2 (NON-WDF)Experimental Group · 2 Interventions: Cisplatin, Laboratory Biomarker Analysis · Intervention Types: Drug, Other
GROUP B1 ARM 4-CDDPExperimental Group · 2 Interventions: Cisplatin, Laboratory Biomarker Analysis · Intervention Types: Drug, Other
GROUP B1 ARM 6-CDDPExperimental Group · 3 Interventions: Cisplatin, Resection, Laboratory Biomarker Analysis · Intervention Types: Drug, Procedure, Other
GROUP B2 ARM IExperimental Group · 3 Interventions: Cisplatin, Resection, Laboratory Biomarker Analysis · Intervention Types: Drug, Procedure, Other
GROUP B2 ARM IIExperimental Group · 2 Interventions: Cisplatin, Laboratory Biomarker Analysis · Intervention Types: Drug, Other
GROUP C ARM C5VDExperimental Group · 5 Interventions: Cisplatin, Doxorubicin, Fluorouracil, Vincristine Sulfate, Laboratory Biomarker Analysis · Intervention Types: Drug, Drug, Drug, Drug, Other
GROUP C ARM CDDPExperimental Group · 3 Interventions: Cisplatin, Resection, Laboratory Biomarker Analysis · Intervention Types: Drug, Procedure, Other
GROUP E1ActiveComparator Group · 3 Interventions: Doxorubicin, Patient Observation, Laboratory Biomarker Analysis · Intervention Types: Drug, Other, Other
Group A1 (WDF)ActiveComparator Group · 2 Interventions: Patient Observation, Laboratory Biomarker Analysis · Intervention Types: Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Doxorubicin
FDA approved
Resection
2021
Completed Phase 2
~400
Etoposide
FDA approved
Fluorouracil
FDA approved
Sorafenib
FDA approved
Gemcitabine
FDA approved
Irinotecan
FDA approved
Vincristine
FDA approved
Oxaliplatin
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
451 Previous Clinical Trials
236,534 Total Patients Enrolled
10 Trials studying Hepatoblastoma
988 Patients Enrolled for Hepatoblastoma
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,161,760 Total Patients Enrolled
23 Trials studying Hepatoblastoma
4,238 Patients Enrolled for Hepatoblastoma
Gregory M TiaoPrincipal InvestigatorChildren's Oncology Group

Eligibility Criteria

Age < 65 · All Participants · 18 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a medical condition caused by a tumor that is affecting the function of a critical organ (such as difficulty breathing or urinary obstruction) and emergency treatment may be needed. You also have a blood clotting issue that cannot be corrected.
References

Frequently Asked Questions

What are doctors treating most often with GROUP B2 (UNRESECTABLE)?

"GROUP B2 (UNRESECTABLE) is a medication used to treat merkel cell cancer. However, it has also shown efficacy when treating neoplasm metastasis, initial treatment, and prostate cancer." - Anonymous Online Contributor

Unverified Answer

Are people with the required medical conditions currently being recruited for this clinical trial?

"That is correct, the information available on clinicaltrials.gov supports that this study is actively looking for patients. The 537 patients needed for the study are being recruited from 100 different sites. The study was first posted on May 23rd, 2018 and updated as recently as October 19th, 2020." - Anonymous Online Contributor

Unverified Answer

From how many different sites is this research being conducted?

"This study is looking for 100 patients from various locations, such as Newark Beth Israel Medical Center, Mary Bridge Children's Hospital and Health Center, Madigan Army Medical Center, and other locations." - Anonymous Online Contributor

Unverified Answer

Are there other ongoing or completed research projects studying GROUP B2 (UNRESECTABLE)?

"At the moment, there are 2464 separate clinical trials underway studying GROUP B2 (UNRESECTABLE) cancer. 740 of those trials are currently in Phase 3. Most of the trials for GROUP B2 (UNRESECTABLE) cancer are based in Guangzhou, Guangdong, but there are 117788 locations running trials for this treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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