Cytoreductive Surgery and HIPEC for Stomach Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Banner Health

Disqualifiers: Solid organ metastases, Infections, Pregnancy, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment for stomach cancer using a combination of surgery and hyperthermic intraperitoneal chemotherapy, applied directly inside the abdomen. The researchers aim to determine the effectiveness of this method for patients whose cancer has spread to the abdominal lining but not to distant organs like the liver or lungs. Participants must have a diagnosis of stomach cancer that has spread to the peritoneum but not beyond, and they should be healthy enough for chemotherapy and surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to potentially groundbreaking advancements in cancer care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that cytoreductive surgery and hyperthermic intraperitoneal chemotherapy is likely to be safe for humans?

Research has shown that combining surgery to remove tumors with a special heated chemotherapy treatment (HIPEC) is generally safe and well-tolerated. One study found this approach feasible and less risky when performed after certain surgeries. Another study noted that patients who received this treatment lived significantly longer, with some extending their lives by up to 27.7 months.

While these results are encouraging, the treatment can still cause side effects. However, studies indicate that many patients manage these effects well. Always discuss any concerns with the study team or your doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stomach cancer?

Researchers are excited about cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) for stomach cancer because it offers a unique approach compared to traditional treatments like systemic chemotherapy and radiation. Unlike these standard treatments that target cancer cells throughout the entire body, HIPEC delivers heated chemotherapy directly to the abdominal cavity during surgery, allowing for higher drug concentrations at the tumor site with potentially fewer systemic side effects. This targeted approach not only aims to remove visible tumors through surgery but also seeks to kill any remaining cancer cells with the heated chemotherapy, which might improve outcomes for patients with advanced stomach cancer.

What evidence suggests that cytoreductive surgery and HIPEC might be an effective treatment for stomach cancer?

In this trial, participants will undergo a combination of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Previous studies have shown promising results for this approach in treating stomach cancer that has spread to the abdominal lining. Research indicates that about 25% to 30% of patients receiving this treatment can be completely cured, significantly improving over other treatments. One study found that patients lived for a median of 24.2 months, with some remaining cancer-free for over two years. Additionally, patients treated with this combination showed better results in terms of how long they lived without cancer progression compared to those who only had surgery. These findings suggest that this approach could be effective for certain patients with stomach cancer. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with stomach cancer, specifically gastric adenocarcinoma that has spread only to the lining of the abdomen. Participants must have either cells from the cancer found in abdominal fluid, hidden metastasis not seen on scans, or visible peritoneal-surface metastatic disease.

Inclusion Criteria

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

My cancer is confirmed as stomach or gastroesophageal junction adenocarcinoma.

Exclusion Criteria

My cancer has spread to organs like the liver, brain, or lungs.

I do not have infections like pneumonia that would stop me from following the treatment plan.

I am not currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Chemotherapy

Participants receive preoperative chemotherapy to prepare for surgery

8-12 weeks

Preoperative Laparoscopic HIPEC

Participants undergo laparoscopic hyperthermic intraperitoneal chemotherapy

1 week

Cytoreductive Surgery and HIPEC

Participants undergo cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Trial Overview The study tests a combination of treatments: preoperative chemotherapy (chemo before surgery), laparoscopic HIPEC (heated chemo delivered inside the abdomen during a minimally invasive procedure), and gastrectomy with CRS/HIPEC (stomach removal followed by extensive surgery to remove tumors and heated chemo).

How Is the Trial Designed?

Group I: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy Experimental Treatment 1 Intervention

Patients will undergo cytoreduction \& hyperthermic intraperitoneal chemotherapy

Who Is Running the Clinical Trial?

Banner Health

Lead Sponsor

Trials

26

Recruited

1,006,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11921698/

Cytoreductive surgery and hyperthermic intraperitoneal ... This study evaluates survival of patients with gastric cancer and peritoneal metastases (GCPM) undergoing CRS and HIPEC at an Australian centre.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798325004287

Survival outcomes of cytoreductive surgery and ... At a mean follow-up of 23.3 months (range 4–48), 25 % of patients remained disease-free, with an estimated median overall survival of 24.2 months. Conclusion.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.02867

Effect of Hyperthermic Intraperitoneal Chemotherapy on ... This study showed no OS difference between CRS + H and CRS-A. PFS and MFS were significantly better in the CRS + H group, which needs further exploration.

4. mayoclinic.org mayoclinic.org/medical-professionals/cancer/news/cytoreductive-surgery-and-hipec-offers-effective-treatment-for-selected-patients-with-peritoneal-carcinomatosis/mac-20429726

Cytoreductive surgery and HIPEC offers effective treatment ... "With HIPEC, it is possible to completely cure 25 to 30 percent of patients with these types of cancer," says Dr. Wasif. "That's a vast improvement on systemic ...

5. jgo.amegroups.org jgo.amegroups.org/article/view/5247/html

Cytoreductive surgery and hyperthermic intraperitoneal ... These data show improved outcomes in patients treated with the multimodality approach together with the studies on the use of intraperitoneal chemotherapy in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21431408/

final results of a phase III randomized clinical trial The median survival was 6.5 months (95% confidence interval 4.8-8.2 months) in CRS and 11.0 months (95% confidence interval 10.0-11.9 months) in the CRS + HIPEC ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03023436

Cytoreductive Surgery Combined With HIPEC and ... This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal ...

8. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1498388/full

Evaluation of the feasibility, safety, and preliminary ... Conclusion: In this real-world dual-center study, HIPEC following D2 surgery was found to be feasible and safe, and was associated with a reduced risk of ...