Abstract 796TiP
Background
The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery improves PFS and OS in stage III ovarian cancer (OV-01 and KOV-01 trials). This trial aims to assess survival benefit of HIPEC in stage III and IV ovarian cancer amidst maintenance therapy with bevacizumab or poly (ADP-ribose) polymerase (PARP) inhibitors.
Trial design
The trial is registered on ClinialTrials.gov (NCT05827523). Ovarian cancer patients will be randomized at the time of interval cytoreductive surgery with residual disease < 2.5mm to receive HIPEC (41.5 cisplatin 75mg/m2, 90 minutes) or not (control arm). After recovery from surgery, patients will receive postoperative platinum-based adjuvant chemotherapy followed by maintenance therapy with bevacizumab or PARP inhibitors. The primary objective of the trial is to evaluate OS in two groups. Secondary objectives are PFS, cancer-specific survival, time to first subsequent therapy (TFST), safety, CA-125 elimination rate constant K (KELIM) score, and quality of life. Assuming that the enrollment period is 5 years and the follow-up period is 3 years, the total number of events required is 263. Based on the log-rank test, the total number of subjects required to prove HR 0.67 with a two-sided alpha of 0.05 and 90% power is 494. 520 patients are finally studied, considering 5% drop-out. Until May 06, 2024, 144 (28.0%) patients are randomized.
Clinical trial identification
NCT05827523.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
870P - POPPY: A phase II trial to assess the efficacy and safety profile of pembrolizumab in patients of performance status 2 with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC)
Presenter: Martin Forster
Session: Poster session 02
871P - Randomized phase II trial of nivolumab plus paclitaxel in subjects with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) unable for cisplatin (CP)-based chemotherapy (CT): NIVOTAX TTCC study
Presenter: Lara Iglesias Docampo
Session: Poster session 02
873P - Nivolumab (NIVO) in the first-line (1L) or second-line (2L) and later (2L+) settings in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Updated results from the German non-interventional study (NIS), HANNA
Presenter: Andreas Dietz
Session: Poster session 02
874P - Preliminary outcomes from a phase Ib/II study of WX390 combined with toripalimab in patients with recurrent or metastatic head and neck squamous cell carcinoma
Presenter: Ye Guo
Session: Poster session 02
875P - A phase II clinical trial of camrelizumab combined with cetuximab and chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)
Presenter: Dongmei Ji
Session: Poster session 02
876P - Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line (1L) treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC)
Presenter: Xiaozhong Chen
Session: Poster session 02
878P - Final results of a phase II study of peltopepimut-S and cemiplimab in patients with relapsed/metastatic HPV16+ oropharyngeal cancer that progressed with prior anti-PD-1 therapy
Presenter: Anthony Kong
Session: Poster session 02
879P - VERSATILE-002: Survival with first-line treatment with PDS0101 therapeutic vaccine and pembrolizumab in HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
Presenter: Jared Weiss
Session: Poster session 02