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TACE + Axitinib + Hydroxychloroquine for Colorectal Cancer (TACE-Ax-HCQ Trial)
Phase 1
Recruiting
Led By Michael C Soulen, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
TACE-Ax-HCQ Trial Summary
This trial is testing a new treatment for liver metastases that may improve progression-free survival.
Who is the study for?
Adults with colorectal adenocarcinoma and measurable liver metastasis, who are in good physical condition (ECOG 0-1), have not had more than two chemotherapy treatments, and no recent radiotherapy or surgery. They must have normal organ function tests, agree to use contraception if of reproductive potential, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the combination of TACE (a procedure that blocks blood flow to cancer cells in the liver) with Axitinib (a drug that inhibits tumor growth) and Hydroxychloroquine (which may prevent cancer cells from surviving under stress). The goal is to see if this combo can better control disease progression in patients whose colorectal cancer has spread mainly to the liver.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, changes in vision due to retinal disease risk from Hydroxychloroquine, bleeding risks from angiography used during TACE, allergic reactions to any of the drugs involved or contrast media used for imaging. Liver function might also be affected.
TACE-Ax-HCQ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serious adverse event (SAE) rate
Secondary outcome measures
Hepatic progression-free survival
Overall survival
Progression-free survival
+2 moreTACE-Ax-HCQ Trial Design
1Treatment groups
Experimental Treatment
Group I: TACE+axitinib+HCQExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine Pill
2020
N/A
~200
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Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,039 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,639 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,961 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have severe liver issues or previous specific liver treatments that would prevent me from undergoing hepatic artery embolization.I cannot undergo certain imaging tests due to severe allergies, uncontrollable bleeding disorders, or severe blood vessel disease.I am allergic to irinotecan, HCQ, or axitinib.I am currently receiving IV treatment for a serious infection.I have a diagnosed eye disease affecting my retina.My blood pressure is higher than 150/100 despite being on stable medication.I have had serious healing issues like non-healing wounds or bone fractures.I am 18 years old or older.I have been diagnosed with colorectal cancer.I have brain metastases but haven't received treatment for them, or I've been treated and am not on steroids.I have a liver metastasis larger than 1 cm.My cancer has mainly spread to my liver, as confirmed by imaging.It's been over 2 weeks since my last chemotherapy and over 4 weeks since my last VEGF therapy.I experience heart-related symptoms like fatigue or shortness of breath with normal activity.I finished my last radiotherapy or surgery at least 2 weeks ago and have recovered from side effects.I am fully active or can carry out light work.My liver is functioning well.I am able and willing to agree to the study's procedures.
Research Study Groups:
This trial has the following groups:- Group 1: TACE+axitinib+HCQ
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity of enrollees for this trial?
"Affirmative. According to clinicaltrials.gov, this trial is currently seeking participants and was initially posted on January 24th 2022 with a final update on May 2nd 2022. The study seeks 25 individuals from one medical centre for participation."
Answered by AI
Has Axitinib 5 MG been granted official clearance by the Federal Drug Administration?
"As a Phase 1 trial, there is limited data for the safety and efficacy of Axitinib 5 MG. Consequently, our team at Power has rated this drug's safety a score of 1."
Answered by AI
Has Axitinib 5 MG been tested in other medical experiments?
"At present, 111 trials are being performed on Axitinib 5 MG. Of those studies, 11 have advanced to Phase 3 and the majority of these experiments take place in Hangzhou, Zhejiang. Altogether there are 1823 sites around the world conducting research for this medication."
Answered by AI
Are there open slots remaining in this clinical experimentation?
"Clinicaltrials.gov shows that this ongoing clinical trial is actively recruiting patients since its initial posting on January 24th, 2022. The study's data was last updated a few months ago on May 2nd of the same year."
Answered by AI
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