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Hyperthermic intraperitoneal perfusion chemotherapy
Hyperthermic intraperitoneal perfusion chemotherapy is a Regional chemotherapy procedure Small molecule drug developed by Sixth Affiliated Hospital, Sun Yat-sen University. It is currently in Phase 3 development for Peritoneal carcinomatosis, Ovarian cancer with peritoneal involvement, Gastric cancer with peritoneal metastases.
Hyperthermic intraperitoneal perfusion chemotherapy delivers heated chemotherapy drugs directly into the peritoneal cavity to treat peritoneal malignancies.
Hyperthermic intraperitoneal perfusion chemotherapy delivers heated chemotherapy drugs directly into the peritoneal cavity to treat peritoneal malignancies. Used for Peritoneal carcinomatosis, Ovarian cancer with peritoneal involvement, Gastric cancer with peritoneal metastases.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Hyperthermic intraperitoneal perfusion chemotherapy |
|---|---|
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Drug class | Regional chemotherapy procedure |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This procedure involves circulating heated chemotherapy solution (typically mitomycin C or other agents) throughout the peritoneal cavity at elevated temperatures (40-43°C) to enhance drug penetration and cytotoxicity while minimizing systemic exposure. The combination of hyperthermia and direct peritoneal contact increases chemotherapy efficacy against peritoneal tumors, particularly those arising from or metastasizing to the peritoneum. The heat also enhances regional drug absorption and may trigger apoptosis in cancer cells.
Approved indications
- Peritoneal carcinomatosis
- Ovarian cancer with peritoneal involvement
- Gastric cancer with peritoneal metastases
- Colorectal cancer with peritoneal involvement
Common side effects
- Abdominal pain
- Nausea and vomiting
- Myelosuppression
- Infection/peritonitis
- Bowel perforation
Key clinical trials
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
- Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy (PHASE2)
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) (PHASE3)
- CRS & HIPEC for Platinum-Resistant Recurrent Ovarian Cancer (KOV-02R, RECOVER) (PHASE3)
- Proactive Temperature Management in CRS-HIPEC for Prevention of Delirium (NA)
- A Prospective, Phase II Clinical Study of HIPEC Combined With NIPS and Tislelizumab Conversion Therapy for Gastric Cancer With Peritoneal Metastasis With Positive Cytology Alone or PCI Score ≤10 (PHASE2)
- Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan (PHASE1, PHASE2)
- Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hyperthermic intraperitoneal perfusion chemotherapy CI brief — competitive landscape report
- Hyperthermic intraperitoneal perfusion chemotherapy updates RSS · CI watch RSS
- Sixth Affiliated Hospital, Sun Yat-sen University portfolio CI
Frequently asked questions about Hyperthermic intraperitoneal perfusion chemotherapy
What is Hyperthermic intraperitoneal perfusion chemotherapy?
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Related
- Drug class: All Regional chemotherapy procedure drugs
- Manufacturer: Sixth Affiliated Hospital, Sun Yat-sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Peritoneal carcinomatosis
- Indication: Drugs for Ovarian cancer with peritoneal involvement
- Indication: Drugs for Gastric cancer with peritoneal metastases
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing