What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as TACE combined with VEGF inhibitors like bevacizumab and autophagy inhibitors, can have several side effects. TACE may cause localized pain, fever, and liver dysfunction. VEGF inhibitors like bevacizumab are associated with hypertension, bleeding, thromboembolic events, and gastrointestinal perforations. Autophagy inhibitors can lead to gastrointestinal disturbances and fatigue. General chemotherapy side effects include nausea, vomiting, diarrhea, neutropenia, and neuropathy. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs targeting the VEGF pathway for the treatment of colorectal cancer. Bevacizumab, an anti-VEGF monoclonal antibody, is commonly used in combination with chemotherapy for metastatic colorectal cancer. Additionally, regorafenib, a multi-kinase inhibitor that targets VEGF receptors, is approved for patients with metastatic colorectal cancer who have progressed on other treatments. While specific FDA approvals for autophagy inhibitors in colorectal cancer are not detailed, the combination of VEGF inhibitors with other agents, such as in the trial involving TACE, axitinib, and hydroxychloroquine, represents an ongoing effort to improve treatment outcomes by targeting multiple pathways involved in cancer cell survival.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include: 1) Immunotherapy combinations, such as pembrolizumab with other checkpoint inhibitors or targeted therapies, which have shown efficacy in various cancers. 2) Personalized medicine approaches, including the use of biomarkers to tailor treatments to individual patients' genetic profiles. 3) Novel targeted therapies, such as those inhibiting specific oncogenes or pathways like KRAS, BRAF, or EGFR. 4) Advanced chemotherapy regimens that combine multiple agents to enhance efficacy and reduce resistance. 5) Emerging therapies like fecal microbiota transplantation (FMT) to modulate the gut microbiome and improve response to existing treatments.

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TACE + Axitinib + Hydroxychloroquine for Colorectal Cancer (TACE-Ax-HCQ Trial)

Phase 1

Waitlist Available

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

No Placebo-Only Group

Summary

This trial tests a combination of two medications and a direct treatment for liver tumors in patients with colorectal cancer that has spread to the liver and not responded to other treatments. The medications aim to make the tumors more vulnerable, while the treatment directly attacks the liver tumors.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serious adverse event (SAE) rate

Secondary study objectives

Hepatic progression-free survival

Overall survival

Progression-free survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer often target key pathways involved in tumor growth and survival. VEGF inhibitors, such as bevacizumab, work by blocking the vascular endothelial growth factor pathway, which is crucial for tumor angiogenesis—the process by which new blood vessels form to supply the tumor with nutrients and oxygen. By inhibiting this pathway, these agents can starve the tumor and inhibit its growth. Additionally, autophagy blockers aim to prevent cancer cells from using autophagy, a survival mechanism where cells degrade and recycle their own components to withstand stress conditions like nutrient deprivation. Combining these approaches, as studied in trials, can potentially improve treatment response and progression-free survival (PFS) by simultaneously cutting off the tumor's blood supply and its ability to survive under stress, offering a more comprehensive attack on cancer cells.