DRAGON-01 Study Reveals Breakthrough in Gastric Cancer Treatment

March 26, 2025   360

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Introduction

 

Gastric cancer remains one of the most challenging malignancies to treat, especially in its advanced stages. In the United States, over 26,000 new cases are diagnosed each year, with many patients already in late-stage progression when symptoms emerge. A particular hurdle arises when the cancer spreads to the peritoneum, the thin lining of the abdominal cavity—a condition known as peritoneal metastasis, which drastically reduces life expectancy.

 

But a major turning point may be here. The DRAGON-01 study, conducted across multiple centers in Japan and recently presented at ASCO GI 2025, brings renewed hope. This Phase III randomized clinical trial examined a novel therapeutic strategy using intraperitoneal paclitaxel in combination with standard systemic chemotherapy. The results? Remarkable.

 

The Challenge of Peritoneal Metastasis in Gastric Cancer

 

Patients with peritoneal metastasis face dismal survival outcomes. Standard treatments—systemic chemotherapy or palliative care—offer limited benefit due to the poor penetration of drugs into the peritoneal cavity. There has been a significant need for a therapy that targets cancer cells more directly within the peritoneum, while still managing systemic disease.

 

DRAGON-01 Study Design and Objective

 

Participants: 222 patients with histologically confirmed gastric cancer and peritoneal metastasis.

 

Eligibility: ECOG performance status 0–1; no bowel obstruction.

 

Study arms:

 

   
• NIPS Group: IP paclitaxel (20 mg/m²), IV paclitaxel (50 mg/m²) on Days 1 and 8, S-1 orally Days 1–14
   
• PS Group: IV paclitaxel (70 mg/m²) + S-1 orally Days 1–14
 

 

Key Findings of the DRAGON-01 Study

 

Median OS: NIPS Group: 19.4 months | PS Group: 13.9 months (HR = 0.66; P = 0.005)

                       

Time Point	NIPS Group	PS Group
1-Year	69.6%	54.1%
2-Year	37.2%	20.3%
3-Year	24.3%	12.2%
5-Year	11.4%	7.9%

 

Conversion Surgery: 50.7% in NIPS vs. 35.1% in PS. OS after surgery: 30.3 vs. 10.1 months.

 

Safety and Side Effects

 

Leukopenia Grade 3–4: 21.7% (NIPS), 24.7% (PS)
     Neutropenia Grade 3–4: 19.9% (NIPS), 23.4% (PS)
     Port-related issues: minimal (reflux, infection, occlusion)

   

💬 Anna’s Perspective: Why DRAGON-01 Stands Out

 

    Working closely with patients who have advanced gastric cancer, I’ve seen how tough it can be when the cancer spreads to the peritoneum. Treatment options are limited, and outcomes are often discouraging. That’s why the DRAGON-01 results feel so important — not just statistically, but humanly. This study doesn’t promise miracles, but it offers something real: a better chance at survival without adding unbearable side effects. Using chemotherapy directly inside the abdominal cavity may sound intense, but for many patients, it could mean the difference between holding on and giving up. It’s not about flashy innovation — it’s about giving people a fighting chance where there wasn’t one before.    

    — Anna Klyauzova, RN, Director of Patient Services
    LinkedIn |      Prolife Home Care Blog  

 

Why This Matters for U.S. Patients

 

   
• S-1 is not FDA-approved, but capecitabine is available
   
• IP chemotherapy is underutilized in U.S. gastric cancer care
   
• This trial may drive regulatory changes and future trials
 

 

What’s Next? Future Implications and Trials

 

   
• U.S.-based studies with IP paclitaxel
   
• Integration with immunotherapy
   
• Innovations in port technology
 

 

Conclusion: DRAGON-01 Is a Game-Changer

 

The DRAGON-01 study offers compelling evidence that adding intraperitoneal chemotherapy significantly improves survival in patients with advanced gastric cancer and peritoneal spread. With manageable side effects and potential for broader use, this trial sets the stage for a paradigm shift in gastric cancer treatment.