Clinical trial NCT05246020: Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)
Official title: Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)：a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hyperthermic Intraperitoneal Chemotherapy
Neoadjuvant Chemotherapy
Keywords: HIPEC
Neoadjuvant chemotherapy
High-grade serous ovarian cancer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The eligible patients will be randomised into an experimental group (NHIPEC +intravenous NACT) or a control group (intravenous NACT). Patients in the NHIPEC experimental group will receive NHIPEC and two cycles of intravenous NACT, while patients in the control group will receive three cycles of intravenous NACT. All patients will undergo IDS within 4weeks after the last cycle of NACT.
Primary purpose: TREATMENT

Brief summary: Background: Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone. Methods: This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60-75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.


Eligibility criteria: Inclusion Criteria:

1. International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC
2. Patients with Fagotti score ≥8
3. Adequate kidney function (blood creatinine 58-96 µmol/L)
4. Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L, neutrophils ≥2.0×109/L, platelets≥100×109/L)
5. Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT ≤1.5)
6. World Health Organization(WHO) score 0-2

Exclusion Criteria:

1. Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy.
2. Patients with complete intestine obstruction.
3. Expected life span ≤8 weeks.
4. Complicated with any other known malignancies.
5. Patients with poor cardiopulmonary function, which would limit compliance with study requirements.

Primary outcomes:
measure: chemotherapy response score(CRS) 3
timeFrame: At the end of cycle 3 NACT (each cycle is 21 days)
Secondary outcomes:
measure: progression-free survival(PFS)
timeFrame: From date of randomization until the date of first documented progression, assessed up to 3 years
measure: overall survival(OS)
timeFrame: From date of randomization until the time of death from any cause, assessed up to 3 years
measure: Rate of R0 resection
timeFrame: At the end of cycle 3 NACT (each cycle is 21 days),when IDS is conducted
measure: NHIPEC-related adverse effects
timeFrame: during the procedure
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Other (Non U.s.)
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jing Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: