NCI HIPEC Phase 1 Trial (NCT04847063)
PHASE1 clinical trial testing HIPEC (heated intraperitoneal chemotherapy) for mesothelioma. Trial NCT04847063 is recruiting.
National Cancer Institute (NCI) is recruiting patients for a PHASE1 clinical trial testing HIPEC (heated intraperitoneal chemotherapy) for mesothelioma.
The trial, designated NCT04847063, aims to enroll up to 60 participants at 1 sites, including locations in Maryland.
About the Study
Background:
Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is heated chemotherapy that washes the abdomen. CRS and HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve results of CRS and HIPEC by choosing the chemotherapy drugs used in HIPEC.
Objective:
To see if HIPEC after CRS can be improved, by testing different chemotherapy drugs, using a model called the SMART (Sample Microenvironment of Resected Metastatic Tumor) System.
Eligibility:
Adults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Computed tomography (CAT) scan
Other imaging scans, as needed
Electrocardiogram (EKG)
Tumor biopsy, if needed
Laparoscopy. Small cuts will be made in the abdomen. A tube with a light and a camera will be used to see their organs.
Some screening tests will be repeated in the study.
Participants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research.
Participants will have CRS. As many of their visible tumors will be removed as possible. They will also have HIPEC. Two thin tubes will be put in their abdomen. They will get chemotherapy through one tube. It will be drained out through the other tube. They will be in the hospital for 7-21 days after surgery.
Participants will give tumor, blood, and fluid samples for research. They will complete surveys about their health and quality of life.
Participants will have follow-up visits over 5 years.
Treatment Approach
This trial uses heated chemotherapy delivered directly into the abdominal cavity during surgery.
Key trial details:
- Phase: PHASE1
- Sponsor: National Cancer Institute (NCI)
- Enrollment target: 60
- Status: RECRUITING
Why This Trial Matters
HIPEC has shown promise for peritoneal mesothelioma, with some patients achieving long-term survival when combined with cytoreductive surgery. This trial is sponsored by the National Cancer Institute, signaling significant federal investment in mesothelioma research.
Study Locations
The trial is recruiting at:
- National Institutes of Health Clinical Center, Maryland
How to Enroll
Patients interested in this trial should:
- Discuss eligibility with their oncologist
- Review the full eligibility criteria on ClinicalTrials.gov
- Contact the study coordinator for screening
Reader Q&A
Frequently Asked Questions
What is the average settlement for asbestos lung cancer?
Asbestos lung cancer settlements average between $100,000 and $400,000, though some cases yield over $1 million depending on exposure history and medical evidence. The overall recovery average across all resolved lung cancer claims is approximately $250,000. Settlements tend to be lower than mesothelioma cases (which average $1 million to $2.4 million) because causation is more difficult to establish when smoking and other environmental factors are involved. Trust fund claims for asbestos lung cancer average $300,000 to $400,000 in total compensation. Trial verdicts occasionally exceed these settlement ranges, with some cases reaching $2 million to $5 million.
Will 30 minutes of asbestos exposure hurt you?
No level of asbestos exposure is safe, but 30 minutes of exposure carries a low risk of causing mesothelioma or other asbestos-related diseases, as risk follows a dose-response relationship tied more to long-term occupational exposure. OSHA notes short exposures as brief as a few days can cause mesothelioma, yet evidence shows one-time or brief incidents like 30 minutes are unlikely to harm unless involving high fiber concentrations, poor ventilation, or amphibole asbestos types. Factors such as visible dust or enclosed spaces elevate potential harm, while intact materials outdoors pose minimal threat. People with any exposure history report details to physicians, as diseases may appear 20-50 years later.
Is mesothelioma one of the worst cancers?
Mesothelioma ranks among the deadliest cancers due to its low 5-year survival rate of 7.2-12% across stages, lower than most others except pancreatic cancer at 7.3%. Localized pleural mesothelioma, the most common type affecting over 75-80% of people with the disease, has a 20% 5-year survival rate, dropping to 8% for distant spread. Median life expectancy after diagnosis ranges from 12-21 months with treatment, often shorter without it, reflecting its aggressive nature linked to asbestos exposure. Factors like stage at diagnosis and treatment access influence individual outcomes.
What is life expectancy with asbestosis?
People with asbestosis have an average life expectancy of about 10 years after diagnosis, though this varies by disease stage and severity. Early-stage cases show around 14 years survival, intermediate stage about 4 years, and advanced stage roughly 1.75 years. Other reports indicate 4 years or less on average , while mild cases may be non-fatal or allow survival for decades depending on exposure levels and overall health. Prognosis data primarily come from observational studies, as no large-scale NIH or NCI trials specifically address asbestosis survival.
How risky is HIPEC surgery?
Evidence from large series shows that combined cytoreductive surgery and HIPEC is a major operation with reported overall complication (morbidity) rates around 30% to 70% and treatment‑related death (mortality) in roughly 0% to 18%, depending on cancer type, disease extent, and center experience. Common issues include abdominal pain, fatigue, digestive changes, low blood counts, infections, bleeding, and slower return of bowel function, while more serious but less common problems include blood clots, anastomotic leaks, organ injury, and pneumonia. HIPEC also carries specific risks from heated chemotherapy such as temporary kidney strain, fluid and electrolyte imbalance, and hematologic toxicity, which some studies describe in 4% to 39% of people. Long‑term risks can include scar tissue (adhesions) that cause chronic abdominal pain or bowel problems, and there remains a risk of cancer recurrence despite treatment. Outcomes and safety reported in the literature are generally better in high‑volume centers using strict protocols and in people with limited disease and good overall health.
Is HIPEC better than traditional chemo?
For some people with cancer limited to the lining of the abdomen, HIPEC has been associated with better survival than traditional chemotherapy alone, especially when surgeons can remove most or all visible disease. HIPEC also delivers chemotherapy directly to the abdomen, which can mean higher local drug levels and fewer whole-body side effects than IV chemotherapy. But the evidence is not uniform across all cancers, and some studies have found no overall survival advantage, even though toxicity was lower. So HIPEC is not broadly better in every situation, but it can be more effective for carefully selected people with peritoneal disease.
Do you lose your hair with HIPEC?
Most published information reports that people receiving HIPEC rarely experience significant hair loss, because the chemotherapy is washed directly through the abdomen with limited absorption into the bloodstream. Large centers such as Mayo Clinic, Penn Medicine, and Stanford describe hair loss as uncommon and note that typical systemic chemotherapy side effects are often avoided. Some hospital leaflets and community reports list temporary hair thinning or hair loss as a possible side effect, but describe it as less common and usually reversible within several months. Online mesothelioma resources also list hair loss as “infrequent,” reflecting that it can occur but at a much lower rate than with intravenous chemotherapy.