Your session is about to expire
← Back to Search
M9241 + HAIP Chemotherapy for Liver Cancers
Phase 2
Recruiting
Led By Jonathan M Hernandez, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must be able to tolerate systemic chemotherapy at initiation of study treatment as outlined below (mCRC: FOLFOX or FOLFIRI; ICC: GemOx or FOLFOX)
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of enrollment until death from any cause, or after 5 years off treatment
Awards & highlights
Study Summary
This trial is testing a new way to treat liver cancer by delivering chemotherapy drugs only to the liver, in combination with a drug that triggers the immune system to fight cancer.
Who is the study for?
Adults with bile duct cancer confined to the liver or colorectal cancer that has spread to the liver. They must be able to handle chemotherapy, agree to use effective contraception, and not breastfeed if applicable. HIV-positive individuals can join if their viral load is undetectable.Check my eligibility
What is being tested?
The trial tests M9241 combined with HAIP-delivered chemo (Floxuridine) and systemic therapy (5-Fluorouracil, Oxaliplatin, Leucovorin for colorectal; Gemcitabine for bile duct). Participants will receive treatments biweekly until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites, immune system activation leading to inflammation in various organs, typical chemotherapy-related issues like nausea and fatigue, as well as increased risk of infections due to lowered immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can undergo chemotherapy with specific drugs for my colorectal or intrahepatic cholangiocarcinoma.
Select...
I am 18 years old or older.
Select...
My liver cancer cannot be fully removed or treated in one procedure.
Select...
My condition cannot be treated with surgery.
Select...
I am HIV-positive with an undetectable viral load.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of operation to date of first observation of progressive disease within the liver or death, or after 5 years off treatment whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of operation to date of first observation of progressive disease within the liver or death, or after 5 years off treatment whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine overall response rates
Secondary outcome measures
Determine extra-hepatic progression-free survival (PFS)
Determine hepatic progression-free survival (PFS)
Determine overall survival (OS)
+1 moreSide effects data
From 2010 Phase 2 trial • 29 Patients • NCT0044876031%
Grade 3 Fatigue
28%
Grade 3 Neutropenia
17%
Grade 3 Diarrhea
10%
Grade 3 Febrile Neutropenia
10%
Grade 4 Neutropenia
3%
Grade 3Thrombocytopenia
3%
Grade 3 Deep Venous Thrombosis
3%
Grade 3 Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/HAIP +M9241+GemOxExperimental Treatment9 Interventions
M9241+HAIP FUDR and Dexamethasone chemotherapy in combination with GemOx
Group II: 1/ HAIP +M9241+FOLFOX or FOLFORIExperimental Treatment8 Interventions
M9241+HAIP FUDR and Dexamethasone chemotherapy in combination with FOLFOX or FOLFIRI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~5730
5-Fluorouracil
2012
Completed Phase 3
~7800
Oxaliplatin
2011
Completed Phase 4
~2560
Gemcitabine
2017
Completed Phase 3
~2070
Dexamethasone
2007
Completed Phase 4
~2590
Floxuridine
2012
Completed Phase 2
~180
Irinotecan
2017
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,689 Previous Clinical Trials
40,930,413 Total Patients Enrolled
4 Trials studying Intrahepatic Cholangiocarcinoma
1,157 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Jonathan M Hernandez, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on steroids for hormone replacement, not exceeding 10 mg of prednisone or its equivalent daily.I can undergo chemotherapy with specific drugs for my colorectal or intrahepatic cholangiocarcinoma.I have not had a stroke, heart attack, severe heart failure, or serious heart rhythm problems in the last 6 months.I have an active Hepatitis B or C infection.I have active bowel disease with poor blood supply.I have not had ulcers in my esophagus or stomach in the last 6 months.I am 18 years old or older.I have a history of serious infections like tuberculosis.I have diabetes type I, vitiligo, alopecia, psoriasis, or thyroid issues without needing immunosuppressive treatment.I have had an organ transplant that doesn't need ongoing immunosuppression.I do not have conditions causing significant tissue death unrelated to cancer.My liver cancer cannot be fully removed or treated in one procedure.I use steroids for conditions other than cancer, but only in forms that don't significantly affect my whole body.I do not have any health conditions that would make this study unsafe for me.My condition cannot be treated with surgery.I agree to use effective birth control during and for 3 months after the study.I am HIV-positive with an undetectable viral load.My cancer has spread to nearby lymph nodes but can be surgically removed.You are not currently taking any experimental drugs for other medical conditions.I have an autoimmune disease that is stable and won't worsen with immune-stimulating treatments.I have previously received rIL-12 treatment.You have a mental health condition or personal circumstances that might make it difficult for you to follow the study rules.I have not had any cancer other than colorectal, basal cell skin, or thyroid in the last 5 years.I have had radiation therapy to my liver.I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.Your arteries in the chest, abdomen, and pelvis can be used for a certain type of treatment called HAIP.I am allergic to certain medications similar to the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ HAIP +M9241+FOLFOX or FOLFORI
- Group 2: 2/HAIP +M9241+GemOx
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 total number of participants in this clinical experiment?
"Affirmative. Per the information gathered from clinicaltrials.gov, this trial is in need of 48 participants and was posted on October 24th 2022, with a recent update occurring two days later. The recruitment process needs to be conducted at one medical site."
Answered by AI
Has Floxuridine earned governmental authorization for its use?
"Our team's evaluation of Floxuridine safety was a 2, as the data collected thus far indicated there is evidence for its security but not yet any studies that demonstrate efficacy."
Answered by AI
Is recruitment still active for this experiment?
"According to clinicaltrials.gov, this trial is currently recruiting participants; the initial post-date was October 24th 2022 and it has been recently updated on October 26th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger