Clinical trial · Interventional
Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of HIPEC as NACT and Postoperative Chemotherapy After Interval Debulking Surgery in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking surgery and 3-year disease-free survival is the primary end points of this project.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| Hyperthermic Intraperitoneal Chemotherapy | Procedure | — | UNRESOLVED |
| Interval debulking surgery | Procedure | — | UNRESOLVED |
| neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- 1. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 2. 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks 3. Interval debulking surgery 4. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 5. 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks
- interventionNames
- Procedure: Hyperthermic Intraperitoneal Chemotherapy
- Procedure: Interval debulking surgery
- Drug: neoadjuvant chemotherapy
- Drug: adjuvant chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- 1. 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks 2. Interval debulking surgery 3. 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III and IV) * Fagotti score by laparoscopic exploration \>= 6 * After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the curative effects evaluated according to RICIST criteria is partial remission (PR) and stable disease (SD). * Residual tumor \< 1cm after completion of interval debulking surgery * 18 \< Age \< 70 year old * Expected survival \> 3 months * Performance status: ECOG 0-1 * Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3 * Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L * Voluntary participation after getting written informed consent. Exclusion Criteria: * Fagotti score by laparoscopic exploration \< 6 * After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the progression of disease (PD) is evaluated by doctor. * Suboptimal debulking (residual tumor \> 1cm) * Extensive adhesion in peritoneal cavity * Previous History of other malignancies (except excision of skin cancer, thyroid cancer) * Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50% * Receiving other chemotherapy, radiotherapy or immunotherapy * Patients who are unsuitable candidates by doctor's decision * Without given written informed consent
References
Publications (0)
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