Clinical trial · Observational
New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer
NCT06120309CI-TRIAL-00071125unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 validated prognostic index for the outcome of advanced high-grade serous ovarian cancer (HGSOC) patients undergoing neoadjuvant chemotherapy (NACT) is still lacking. To address this need, we developed an ovarian neoadjuvant chemotherapy prognostic index (ONCPI) to improve predictive accuracy. We analyzed the clinicopathological characteristics of advanced HGSOC patients receiving platinum-based NACT. Blood inflammatory composite markers were calculated and binary-transformed using optimal cutoffs. Omental hematoxylin and eosin (H\&E) stained slides were selected for the assessment of chemotherapy response score (CRS). Logistic regression analysis and Cox proportional hazards regression model were utilized to develop a prognostic index.
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 |
|---|---|---|---|
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prognostic Cancer Model | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRS scoring | Diagnostic Test | — | UNRESOLVED |
| Routine blood laboratory testing before treatment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NACT Group
- interventionNames
- Diagnostic Test: CRS scoring
- Diagnostic Test: Routine blood laboratory testing before treatment
Primary outcomes (1)
- measure
- Response to platinum-based chemotherapy
- timeFrame
- At least 6 months after initial chemotherapy
- description
- After NACT-IDS and postoperative adjuvant chemotherapy, treatment efficacy was assessed according to NCCN guidelines. For primary tumor, patients who relapsed 6 months or more after initial chemotherapy were termed platinum-sensitive. In contrast, patients whose disease recurred in less than 6 months were classified as platinum-resistant.
Secondary outcomes (2)
- measure
- 3-year progression-free survival (PFS)
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. confirmed diagnosis of HGSOC by two experienced pathologists; 2. clinical stage III-IV according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) guideline; 3. Eastern Cooperative Oncology Group (ECGO) performance status of 0 to 1; 4. no prior anti-cancer therapy; 5. received ≥ 3 cycles of platinum-based NACT followed by IDS; 6. complete pretreatment blood test results and clinical and imaging data. Exclusion Criteria: 1. other pathological types; 2. without NACT or IDS; 3. incomplete pretreatment data; 4. lost to follow-up.
References
Publications (5)
- RESULTHudry D, Becourt S, Scambia G, Fagotti A. Primary or Interval Debulking Surgery in Advanced Ovarian Cancer: a Personalized Decision-a Literature Review. Curr Oncol Rep. 2022 Dec;24(12):1661-1668. doi: 10.1007/s11912-022-01318-9. Epub 2022 Aug 15. PMID 35969358
- RESULTColombo N, Sessa C, du Bois A, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent diseasedagger. Ann Oncol. 2019 May 1;30(5):672-705. doi: 10.1093/annonc/mdz062. PMID 31046081
- RESULTLiang WF, Wang LJ, Li H, Liu CH, Wu MF, Li J. The added value of CA125 normalization before interval debulking surgery to the chemotherapy response score for the prognostication of ovarian cancer patients receiving neoadjuvant chemotherapy for advanced disease. J Cancer. 2021 Jan 1;12(3):946-953. doi: 10.7150/jca.52711. eCollection 2021. PMID 33403051
- RESULTLi C, Wu J, Jiang L, Zhang L, Huang J, Tian Y, Zhao Y, Liu X, Xia L, E H, Gao P, Hou L, Yang M, Ma M, Su C, Zhang H, Chen H, She Y, Xie D, Luo Q, Chen C. The predictive value of inflammatory biomarkers for major pathological response in non-small cell lung cancer patients receiving neoadjuvant chemoimmunotherapy and its association with the immune-related tumor microenvironment: a multi-center study. Cancer Immunol Immunother. 2023 Mar;72(3):783-794. doi: 10.1007/s00262-022-03262-w. Epub 2022 Sep 3. PMID 36056951
- RESULTRodolakis I, Pergialiotis V, Liontos M, Haidopoulos D, Loutradis D, Rodolakis A, Bamias A, Thomakos N. Chemotherapy Response Score in Ovarian Cancer Patients: An Overview of Its Clinical Utility. J Clin Med. 2023 Mar 10;12(6):2155. doi: 10.3390/jcm12062155. PMID 36983157