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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
Must not have
Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke < 6 months prior to enrollment, myocardial infarction < 6 months prior to enrollment, unstable angina, congestive heart failure (>= NYHA III) or serious cardiac arrhythmia requiring medication
Subjects with active Hepatitis B or C infection
Timeline
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
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can undergo chemotherapy with specific drugs for my colorectal or intrahepatic cholangiocarcinoma.
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I am 18 years old or older.
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My liver cancer cannot be fully removed or treated in one procedure.
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My condition cannot be treated with surgery.
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I am HIV-positive with an undetectable viral load.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a stroke, heart attack, severe heart failure, or serious heart rhythm problems in the last 6 months.
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I have an active Hepatitis B or C infection.
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I have active bowel disease with poor blood supply.
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I have a history of serious infections like tuberculosis.
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I do not have conditions causing significant tissue death unrelated to cancer.
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I have previously received rIL-12 treatment.
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I have had radiation therapy to my liver.
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I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.
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I am allergic to certain medications similar to the study drug.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine overall response rates
Secondary study objectives
Determine extra-hepatic progression-free survival (PFS)
Determine hepatic progression-free survival (PFS)
Determine overall survival (OS)
+1 more

Side effects data

From 2010 Phase 2 trial • 29 Patients • NCT00448760
31%
Grade 3 Fatigue
28%
Grade 3 Neutropenia
17%
Grade 3 Diarrhea
10%
Grade 4 Neutropenia
10%
Grade 3 Febrile 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/HAIP +PDS01ADC+GemOxExperimental Treatment9 Interventions
PDS01ADC+HAIP FUDR and Dexamethasone chemotherapy in combination with GemOx
Group II: 1/ HAIP +PDS01ADC+FOLFOX or FOLFORIExperimental Treatment8 Interventions
PDS01ADC+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
~6010
Oxaliplatin
2011
Completed Phase 4
~2890
5-Fluorouracil
2012
Completed Phase 3
~7800
Gemcitabine
2017
Completed Phase 3
~1920
Dexamethasone
2007
Completed Phase 4
~2650
Floxuridine
2012
Completed Phase 2
~180
Irinotecan
2017
Completed Phase 3
~2590

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,112,023 Total Patients Enrolled
107 Trials studying Cholangiocarcinoma
10,884 Patients Enrolled for Cholangiocarcinoma
Jonathan M Hernandez, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
1,864 Total Patients Enrolled
3 Trials studying Cholangiocarcinoma
1,841 Patients Enrolled for Cholangiocarcinoma

Media Library

Intera 3000 Hepatic Artery Infusion Pump (HAIP) Clinical Trial Eligibility Overview. Trial Name: NCT05286814 — Phase 2
Cholangiocarcinoma Research Study Groups: 1/ HAIP +PDS01ADC+FOLFOX or FOLFORI, 2/HAIP +PDS01ADC+GemOx
Cholangiocarcinoma Clinical Trial 2023: Intera 3000 Hepatic Artery Infusion Pump (HAIP) Highlights & Side Effects. Trial Name: NCT05286814 — Phase 2
Intera 3000 Hepatic Artery Infusion Pump (HAIP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05286814 — Phase 2
~41 spots leftby Dec 2027
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