Clinical trial · Interventional
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
A Phase III Clinical Trail of Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent 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)
A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.
Conditions
Conditions (6)
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 |
| Hyperthermic Intraperitoneal Chemotherapy(HIPEC) | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer, Epithelial | Ovarian Carcinoma | ALIAS | 0.90 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovary Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRS | Device | — | UNRESOLVED |
| HIPEC | Device | — | UNRESOLVED |
| IVCT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIPEC
- description
- Patients will undergo a CRS plus HIPEC and IVCT. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the abdominal cavity is bathed in a warm solution of anti-cancer medications for 60 minutes. A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.
- interventionNames
- Device: HIPEC
- Device: CRS
- Device: IVCT
- type
- OTHER
- label
- Non HIPEC
- description
- Patients will undergo only CRS and IVCT. Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS.
- interventionNames
- Device: CRS
- Device: IVCT
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * age 18-75 * Karnofsky performance status \>50 or World Health Organization performance score \< 2 * primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal) * preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan) * lesion can be removed completely or residual disease \< 0.5 cm * last chemotherapy finished no more than 12 weeks after surgery * no hepatic function damage * white blood cell count ≥3.5\*10\^9/L; platelet count ≥80\*10\^9/L; Hemoglobin ≥90g/L * no contraindication of surgery and anesthesia * life expectancy ≥ 3 months Exclusion Criteria: * age \< 18 or \>75 * no history of other cancer * platinum allergy * distant metastasis * used anti-angiogenic drug within 8 weeks * possibility of more than two resection of alimentary canal * recurrence \< 6 months after primary treatment * histologic type: non epithelial origin * infection out of control * follow-up unable to carry on (geographic or psychic) * cardiac insufficiency or respiratory insufficiency * has received HIPEC already * being in other clinical study * pregnancy or lactation period
References
Publications (0)
Data not yet available