Trial · NCT05468359

Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients

NCT05468359, Phase 1, Phase 2, Recruiting, St. Jude Children's Research Hospital

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients. Trials, record NCT05468359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05468359

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients
NCT number: NCT05468359
Status: Recruiting
Phases: Phase 1, Phase 2
Enrollment: 64 participants, estimated
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Refractory Solid Tumor, Hepatocellular Carcinoma, Malignant Solid Tumor, Pediatric Cancer, Pediatric Solid Tumor, Fibrolamellar Carcinoma
Interventions: Atezolizumab, Sorafenib, Bevacizumab, Cyclophosphamide
First posted: 2022-07-21
Last updated: 2026-05-19

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Part 1: Recommended phase 2 doses (RP2Ds)	At the end of cycle 2 (each cycle is 21 days)]	The number of participants who develop a dose limiting toxicity within the first two cycles of therapy that are at least possibly, probably or definitely attributable to atezolizumab, bevacizumab, sorafenib or cyclophosphamide.
Primary	PK measures of Sorafenib	At the end of cycle 1 (each cycle is 21 days)]	The number of participants exhibiting a sorafenib exposure (steady-state AUC0-12h) between 20 and 55 hr·µg/mL by Day 21 of cycle 1.
Primary	Part 2: Response rate	At the end of cycle 2 (each cycle is 21 days)]	The number of participants with relapsed or refractory HCC whose tumors show a response (CR+PR) after 2 cycles of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab
Primary	PK measure of sorafenib	At the end of cycle 1 (each cycle is 21 days)]	The number of participants who have a sorafenib systemic exposure between 20 and 55 who experience sorafenib-induced skin toxicity compared to the number of participants who have a systemic sorafenib exposure outside of the 20-55 range who experience sorafenib-induced skin toxicity.
Primary	Parts 1 & 2: Intratumoral T-cell infiltration of CD8+C45RO+ cells	At the end of cycle 2 (each cycle is 21 days)]	The number of participants whose tumors show an increase in the ratio of CD45RO+/CD3+ T cells of at least 27% OR who show an absolute increase in CD3+ cells from baseline to the end of cycle 2 (approximately 42 days from the start of therapy).
Secondary	Part 1:Response rate of relapsed or refractory solid tumors	At the end of cycle 2 (each cycle is 21 days)]	The number of participants with relapsed or refractory solid tumors whose tumors have a response (CR or PR) after two cycles of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab.
Secondary	Part 2: Response rate of relapsed or refractory fibrolamellar carcinoma, desmoplastic small round cell tumor, malignant rhabdoid tumor	At the end of cycle 2 (each cycle is 21 days)]	The number of participants with relapsed or refractory fibrolamellar carcinoma, desmoplastic small round cell tumor, malignant rhabdoid tumor, and other rare solid tumors whose tumors have a response (CR or PR) after two cycles of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab.
Secondary	Resection rate of liver tumors	At the end of cycle 1 (each cycle is 21 days)]	The number of participants with liver tumors, initially judged relapsed or refractory at diagnosis, that can have their primary tumor resected after treatment with oral cyclophosphamide and sorafenib with intravenous bevacizumab and atezolizumab.
Secondary	Progression Free Survival	At the end of cycle 2 (each cycle is 21 days	The PFS of patients treated with the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab, and atezolizumab in patients with relapsed or refractory HCC, DSRCT, MRT, FL-HCC and other rare solid tumors.
Secondary	Event Free Survival	At the end of cycle 2 (each cycle is 21 days	The EFS of patients treated with the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab, and atezolizumab in patients with relapsed or refractory HCC, DSRCT, MRT, FL-HCC and other rare solid tumors.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

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.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT05468359

GET https://conductscience.org/api/trials/v1/NCT05468359/registered

API reference For AI assistants