TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC) (TACE-Ax-HCQ)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04873895|
Recruitment Status : Not yet recruiting
First Posted : May 5, 2021
Last Update Posted : May 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms Malignant||Drug: Axitinib 5 MG Drug: Hydroxychloroquine Pill Procedure: trans arterial chemoembolization||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single-center open-label Phase 1B trial|
|Masking:||None (Open Label)|
|Official Title:||Phase 1B Study of Hepatic Chemoembolization Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Adenocarcinoma Of The Colon And Rectum|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||November 2023|
2 weeks of axitinib 5mg BID and hydroxychloroquine 600 mg BID followed by lobar or segmental trans arterial chemoembolization monthly until the entire tumor burden is treated, then continue axitinib/HCQ until progression or intolerable toxicity.
Drug: Axitinib 5 MG
axitinib 5 mg po BID until progression or intolerance
Drug: Hydroxychloroquine Pill
hydroxychloroquine 600 mg po BID until progression or intolerance
Procedure: trans arterial chemoembolization
segmental or lobar TACE at 4-8 week intervals until entire tummy burden is treated.
- Serious adverse event (SAE) rate [ Time Frame: 12 months ]SAE is scored by CTCAE v5 (G3 or higher) and the 2017 revision of the Society of Interventional Radiology (SIR) Complications Classification categories 3-5.
- objective response rate in the liver [ Time Frame: 3 months ]complete and partial response rate by RECIST and modified RECIST
- Hepatic progression-free survival [ Time Frame: 12 months ]Time from initiation of therapy to progression in the liver by RECIST, death from any cause, or last documented progression-free status.
- Progression-free survival [ Time Frame: 12 months ]Time from initiation of therapy to progression anywhere by RECIST, death from any cause, or last documented progression-free status.
- Overall survival [ Time Frame: 24 months ]Time from initiation of therapy to death or last follow-up alive
- axitinib treatment intensity [ Time Frame: 12 months ]Weeks on axitinib therapy multiplied by percentage of initially prescribed dose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873895
|Contact: Michael C Soulen, MDemail@example.com|
|Contact: Mark O'Hara, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Abramson Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Chief Compiance Officer email@example.com|
|Principal Investigator:||Michael C Soulen, MD||Abramson Cancer Center|