Trial · NCT05468359
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Overall 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. |
| Secondary | Systemic immune activation correlation with tumor response | after 2 courses of therapy (each cycle is 21 days | The number of participants who show an activated systemic T-cell response and who have a CR or PR after two courses of cyclophosphamide, PK-guided sorafenib, bevacizumab, and atezolizumab. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT05468359/registered