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Monoclonal Antibodies

Chemotherapy + Bevacizumab + Tumor Treating Fields Therapy for Liver Cancer

Phase 1
Recruiting
Led By Siqing Fu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., hormonal, barrier device, or abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose of the study agents
Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 50 mL/minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new combination of chemotherapy drugs with bevacizumab, and a new portable device that uses electrical fields to stop the growth of tumor cells, in people with cancer that has come back or does not respond to treatment and has spread to the liver.

Who is the study for?
This trial is for adults with advanced colorectal cancer that has spread to the liver and isn't responding to treatment. They must have a certain level of white blood cells, at least half their tumor in the liver, specific genetic features in their cancer, and measurable disease. Participants need normal organ function and can't be pregnant or breastfeeding. They should not have serious illnesses or conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests how well a combination of chemotherapy drugs (oxaliplatin, leucovorin, fluorouracil) plus pegylated liposomal doxorubicin hydrochloride and temsirolimus works alongside Bevacizumab (a monoclonal antibody) when used with NovoTTF-100L(P), a device designed to disrupt cancer cell growth using electrical fields.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy reactions like nausea, fatigue, hair loss; Bevacizumab may cause bleeding or blood clots; NovoTTF-100L(P) might lead to skin irritation where it's applied. Each patient's experience can vary based on individual health factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control during and for 30 days after the study.
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My kidney function is normal or only slightly reduced.
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My cancer does not respond to standard treatments or there are none available.
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My cancer has a specific genetic change related to the PI3K pathway.
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I may have radiation for symptom relief, not aimed at my main cancer spots.
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My liver cancer mainly spreads from another part and has a specific gene change.
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I have colorectal cancer that has mainly spread to my liver.
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Half of my cancer spread is in my liver.
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My liver enzyme (ALT) levels are within the acceptable range.
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I am able to care for myself and up to being unable to work but can still move around.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Biomarker analysis
Response

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B(bevacizumab,liposomal doxorubicin, DAT, NovoTTF-100L[P])Experimental Treatment4 Interventions
Participants receive bevacizumab IV over 90 minutes on days 1 and 15, pegylated liposomal doxorubicin hydrochloride IV over 30 minutes-3 hours on days 1 and 15, and temsirolimus IV over 60-90 minutes on days 1, 8, 15, and 22. Participants also use NovoTTF-100L(P) system over 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (FOLFOX6, bevacizumab, NovoTTF-100L[P])Experimental Treatment5 Interventions
Participants receive oxaliplatin, leucovorin, and fluorouracil via pump over 46 hours on beginning on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and use NovoTTF-100L(P) system over 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2560
Bevacizumab
2013
Completed Phase 4
~5280
Pegylated Liposomal Doxorubicin Hydrochloride
2001
Completed Phase 3
~4520
Temsirolimus
2008
Completed Phase 2
~1940
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,313 Total Patients Enrolled
22 Trials studying Liver Cancer
9,411 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,295 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Siqing FuPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
490 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03203525 — Phase 1
Liver Cancer Research Study Groups: Arm B(bevacizumab,liposomal doxorubicin, DAT, NovoTTF-100L[P]), Arm A (FOLFOX6, bevacizumab, NovoTTF-100L[P])
Liver Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03203525 — Phase 1
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03203525 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there prior experience with Pegylated Liposomal Doxorubicin Hydrochloride research?

"At present, 1294 trials are being conducted on the efficacy of Pegylated Liposomal Doxorubicin Hydrochloride. Of those experiments, 373 have reached Phase 3 levels and 56730 sites across Guangzhou, Guangdong are running them."

Answered by AI

Are there presently any opportunities to participate in this experiment?

"Based on the details available at clinicaltrials.gov, this research is still seeking participants. It was first advertised to potential enrollees in June 2020 and has been actively updated since then, with its most recent revision occurring on May 13th 2022."

Answered by AI

Has the Food and Drug Administration granted authorization for Pegylated Liposomal Doxorubicin Hydrochloride?

"As this is a Phase 1 trial, with limited evidence of safety and efficacy, the risk associated with Pegylated Liposomal Doxorubicin Hydrochloride was estimated to be low at a score of 1."

Answered by AI

What conditions commonly benefit from Pegylated Liposomal Doxorubicin Hydrochloride?

"Pegylated Liposomal Doxorubicin Hydrochloride is primarily employed to treat joints, but has also been found efficacious in treating typhus, HIV-associated Kaposi's sarcoma and Helicobacter pylori infections."

Answered by AI

Has anything like this trial been conducted before?

"According to current information, there are 1294 ongoing studies for Pegylated Liposomal Doxorubicin Hydrochloride in 76 countries and 3205 cities. The first trial of this drug took place in 1997 and was sponsored by Alfacell. This Phase 3 clinical trial included 300 participants before its completion. Subsequently, 2922 additional trials have been conducted since then."

Answered by AI

How many participants are being accepted for this experimental study?

"Affirmative. Clinicaltrials.gov has the most up-to-date information, which attests to this clinical trial's active recruitment drive that began on June 23rd 2020 and was last updated on May 13th 2022. 52 participants are needed from 1 medical centre for this endeavour."

Answered by AI
~22 spots leftby Dec 2026