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NCT05620654
A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin
Phase 1 trial testing Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin in Ovarian Cancer in 30 participants. Status unknown.
1 May 2023
Quick facts
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 December 2022 |
| Primary completion | 1 May 2023 |
| Estimated completion | 1 May 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Hyperthermic Intraperitoneal Chemotherapy — all drugs for Hyperthermic Intraperitoneal Chemotherapy →
- Paclitaxel — all drugs for Paclitaxel →
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Who can join
Adults 18 to 75, female only, with Ovarian Cancer or Hyperthermic Intraperitoneal Chemotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary objective of this trial is to identify the maximum tolerated dose (MTD) of paclitaxel combined with a fixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer. In this single-center Phase I trial, Bayesian Optimal Interval Design (TITE-BOIN) was used. The starting dose for paclitaxel was 175 mg/m2, with escalation in 25 mg/m2 increments until the MTD was determined or the maximum dose level of 225 mg/m2 was reached. The target dose-limiting toxicity (DLT) rate was 25%, and the total sample size was 30 patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05620654
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05620654 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Last refreshed: 17 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05620654.
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