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Checkpoint Inhibitor
Immunotherapy + Chemotherapy for Bile Duct Cancer (ICC Trial)
Phase 1 & 2
Waitlist Available
Led By Olumide Gbolahan, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T1b-T4 tumor thought to be technically resectable
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 24 months
Awards & highlights
ICC Trial Summary
This trial will assess if a combination of two immunotherapies and platinum-based chemotherapy can improve resection rates in cholangiocarcinoma, a type of liver cancer. The hope is that this will reduce recurrence rates and improve survival.
Who is the study for?
Adults over 18 with intrahepatic cholangiocarcinoma that's considered resectable, but high-risk for recurrence. They should have a good performance status (ECOG 0 or 1), weigh more than 30 kg, and have proper organ/marrow function. Women must not be pregnant and participants must consent to biopsies. Exclusions include prior treatments for this cancer type, other active cancers or severe illnesses, known allergies to trial drugs, recent vaccines, immunosuppressant use, or unwillingness to use birth control.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining two immunotherapy drugs (durvalumab and tremelimumab) with platinum-based chemotherapy (gemcitabine and cisplatin). The goal is to see if this treatment can improve surgery outcomes by shrinking tumors before removal and potentially extend survival while also identifying biomarkers predicting therapy response.See study design
What are the potential side effects?
Possible side effects may include immune-related inflammation in various organs, reactions at the infusion site where medication enters the body through a vein, fatigue, digestive issues like nausea or diarrhea, blood cell count changes which could increase infection risk. Each patient might experience these differently.
ICC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is considered operable by my doctor.
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I am post-menopausal or not pregnant if pre-menopausal.
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My cancer has spread to nearby lymph nodes but can be surgically removed.
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My cancer has multiple tumors or satellite lesions in the same lung lobe and can be surgically removed.
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I am fully active or can carry out light work.
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My body weight is over 30 kg.
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My cancer is high risk due to its size, spread, or involvement with blood vessels but can still be surgically removed.
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My cancer is confirmed as intrahepatic cholangiocarcinoma through tests.
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My cancer has not spread beyond my liver.
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My tumor is larger than 5cm and needs treatment to shrink it before surgery.
Select...
My tumor, despite having blood vessel involvement, can be surgically removed.
ICC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the objective response rate (ORR) based of the rate of partial and complete responses to the combination of intervention agents
Secondary outcome measures
Determine changes in the tumor mRNA gene expression pattern, phenotype of circulating cytotoxic T cells, and changes in circulating markers of immunogenic cell death following treatment with intervention agents
Determine the rate of completion of preoperative therapy
Determine the safety of the combination of intervention agents by assessing the percentage of patients who experience dose limiting toxicities or develop adverse reactions
ICC Trial Design
1Treatment groups
Experimental Treatment
Group I: Novel combination of chemotherapy and immunotherapyExperimental Treatment1 Intervention
This study has one arm. All enrolled patients will receive a combination of a platinum based chemotherapy regimen (gemcitabine and cisplatin) and a combination of two immune check point inhibitors, anti- CTLA4 (Tremelimumab) and anti PDL-1 (durvalumab).
Gemcitabine will be administered (gemzar) intravenously, 1000mg/m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles. Cisplatin (Platinol) will be administered intravenously, 25mg//m2 on Day 1 and Day 8 of a 21 day cycle for up to 4 cycles.
Tremelimumab will be administered intravenously, 300mg flat dose, on Day 1 of cycle 1 only. Durvalumab will be administered intravenously 1500mg on Day 1 of a 21 day cycle for 4 cycles.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,292 Total Patients Enrolled
Olumide Gbolahan, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Moh'd Khushman, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a sample of my tumor and am willing to undergo a biopsy after some treatment.My cancer is measurable, high-risk but can still be surgically removed.My tumor is considered operable by my doctor.I don't have major side effects from cancer treatment, except for hair loss or skin changes.I am over 18 years old.You have received an organ transplant from someone else in the past.I have not received a live vaccine in the last 30 days.You have participated in another study testing a new medication in the last 3 months.My cancer is considered high risk but can still be surgically removed.I've had a severe allergic reaction to specific cancer immunotherapies before.I am post-menopausal or not pregnant if pre-menopausal.My cancer has spread to nearby lymph nodes but can be surgically removed.My cancer has multiple tumors or satellite lesions in the same lung lobe and can be surgically removed.I understand and agree to the study's requirements and have signed the consent form.I am able to understand and sign the consent form.My cancer has spread to areas far from the liver.I have cancer of the ampulla, bile ducts outside the liver, or gallbladder.I have had cancer before, but it was a specific type that's allowed.You have participated in a previous clinical study for the drugs durvalumab and/or tremelimumab.I am fully active or can carry out light work.I have received treatment for a specific type of liver cancer before surgery was considered.I have previously been treated with specific immune therapies under certain conditions.I do not have active infections like TB, hepatitis B, C, or HIV.I do not have any unmanaged ongoing illnesses.My body weight is over 30 kg.My organs and bone marrow are functioning well.I have not had major surgery in the last 28 days.My cancer is not adenocarcinoma or a mix with hepatocellular carcinoma.My cancer is high risk due to its size, spread, or involvement with blood vessels but can still be surgically removed.My doctor says I can't have platinum-based chemotherapy due to health reasons.I haven't taken immunosuppressive drugs in the last 14 days.You are expected to live for at least 6 more months.My cancer is confirmed as intrahepatic cholangiocarcinoma through tests.I have or had an autoimmune or inflammatory disorder.My cancer has not spread beyond my liver.My tumor is larger than 5cm and needs treatment to shrink it before surgery.My tumor, despite having blood vessel involvement, can be surgically removed.I am not pregnant, breastfeeding, and if capable of having children, I agree to use birth control.You are allergic or highly sensitive to any of the study drugs or their ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Novel combination of chemotherapy and immunotherapy
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.
Is this research project open to patients who are seniors?
"The age requirements for this study are that participants must be between 18-89 years old."
Answered by AI
Are people with this condition able to participate in the trial at this time?
"Indeed, the clinical trial is still looking for participants and was last updated on October 6th, 2022. 20 patients are needed from a single location."
Answered by AI
How can I become a subject in this experiment?
"Eligible participants for this clinical trial must have cholangiocarcinoma and be between 18-89 years old. Right now, the research team is looking to enroll a total of 20 patients."
Answered by AI
Are there other scientific examples of this new cancer treatment being used?
"As of now, there are 1294 live clinical trials for Novel combination of chemotherapy and immunotherapy. Most of these trials (376) are in Phase 3. Clinical trial locations for this treatment option are widely available with 61551 different centres conducting research at the moment."
Answered by AI
What do oncologists think of this new chemotherapy and immunotherapy treatment?
"The cancers of the urinary bladder, advanced testicular cancer, and small cell lung cancer (sclc) can all be effectively treated by a new combination chemotherapy and immunotherapy treatment."
Answered by AI
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