Clinical Trials Updated Medically Reviewed 6 min read

NCI HIPEC Phase 2 Trial (NCT05001880)

PHASE2 clinical trial testing HIPEC (heated intraperitoneal chemotherapy) for mesothelioma. Trial NCT05001880 is recruiting.

NCI HIPEC Phase 2 Trial (NCT05001880)

National Cancer Institute (NCI) is recruiting patients for a PHASE2 clinical trial testing HIPEC (heated intraperitoneal chemotherapy) for mesothelioma.

The trial, designated NCT05001880, aims to enroll up to 66 participants at 39 sites, including locations in Arizona, Illinois, Kentucky.

About the Study

This phase II trial compares the usual treatment alone (carboplatin, pemetrexed, and bevacizumab) to using immunotherapy (atezolizumab) plus the usual treatment in treating patients with peritoneal mesothelioma. The usual treatment consists of surgery or chemotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill cancer cells. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with usual treatment may work better than usual treatment alone.

Treatment Approach

This trial uses heated chemotherapy delivered directly into the abdominal cavity during surgery.

Key trial details:

  • Phase: PHASE2
  • Sponsor: National Cancer Institute (NCI)
  • Enrollment target: 66
  • 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:

  • Mayo Clinic Hospital in Arizona, Arizona
  • University of Chicago Comprehensive Cancer Center, Illinois
  • Carle at The Riverfront, Illinois
  • Carle Physician Group-Effingham, Illinois
  • Carle Physician Group-Mattoon/Charleston, Illinois

How to Enroll

Patients interested in this trial should:

  1. Discuss eligibility with their oncologist
  2. Review the full eligibility criteria on ClinicalTrials.gov
  3. Contact the study coordinator for screening

Reader Q&A

Frequently Asked Questions

Can asbestos be surgically removed?

No medical treatment, including surgery, can remove asbestos fibers from the lungs once inhaled. These fibers remain embedded in lung tissue, causing irreversible scarring in asbestosis, with treatments focusing on symptom relief and disease progression management. For people with mesothelioma, surgery such as extrapleural pneumonectomy or pleurectomy/decortication aims to remove tumors from the pleura or chest lining, but it cannot address the underlying asbestos fibers and is limited to early-stage cases based on location and health. Long-term outcomes from aggressive surgeries like extrapleural pneumonectomy do not support routine use.

What is the life expectancy of someone with peritoneal mesothelioma?

People with peritoneal mesothelioma have an average life expectancy of 53 months with cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC), compared to 6-12 months without treatment. The 5-year survival rate is 65%, rising to about 80% with cytoreduction, HIPEC, and follow-up chemotherapy in eligible cases. Survival varies by cell type, with epithelioid averaging over 31 months and sarcomatoid around 5 months after treatment.

What is a rare cancer caused by asbestos?

Mesothelioma is a rare cancer caused by asbestos exposure, primarily affecting the mesothelium lining the lungs (pleura), abdomen (peritoneum), heart (pericardium), or testes. Asbestos fibers inhaled or ingested lodge in these tissues, causing chronic inflammation and DNA mutations that lead to cancer over decades. Pleural mesothelioma accounts for 80% of cases, peritoneal for 20%, and pericardial or testicular types for less than 1%.

How long does it take for mesothelioma to manifest after exposure?

The latency period for mesothelioma, defined as the time from initial asbestos exposure to diagnosis, typically ranges from 10 to 60 years, with a median of about 34 years. Studies report mean latencies of 33.7 years in a South Korean cohort of 923 people with malignant mesothelioma and 22.8 years overall, though many people with mesothelioma experience symptoms 30 to 50 years post-exposure. Factors like exposure intensity, duration, asbestos type, age at exposure, and genetics influence this period, with higher or occupational exposures often linked to shorter latencies. Rare cases manifest in under 10 years or over 70 years.

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.

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.

How painful is HIPEC surgery?

HIPEC surgery occurs under general anesthesia, so people with mesothelioma feel no pain during the procedure. Postoperatively, people experience abdominal pain or discomfort, often described as soreness, tightness, or pressure that peaks in the first few days and improves with medication such as opioids, NSAIDs, or nerve blocks. Pain levels vary by surgery extent, cancer type, and individual tolerance, but sources report it as manageable and temporary with medical team support. Common side effects include fatigue, nausea, and bowel changes alongside pain.