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A Trial for Dose-finding of Hyperthermic Intraperitoneal Cisplatin in Patients Receiving Hyperthermic Intraperitoneal Chemotherapy

A Trial for Dose-finding of Hyperthermic Intraperitoneal Cisplatin in Patients Receiving Hyperthermic Intraperitoneal Chemotherapy

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021555
Enrollment
Unknown
Registered
2019-02-27
Start date
2019-03-15
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic oncology

Interventions

1:calculate the amount of cisplatin with dose level 70mg/m2
2:calculate the amount of cisplatin with dose level 75mg/m2
3:calculate the amount of cisplatin with dose level 80mg/m2
4:calculate the amount of cisplatin with dose level 85mg/m2

Sponsors

Sun Yat-Sen Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who have the complications to received HIPEC; 2. Age 18 to 65 years; 3. Level of blood creatine is within the normal range before HIPEC,that is 58-96µmol/L; 4. No bone marrow inhibition before HIPEC; 5. Normal hepatic function before HIPEC; 6. Patient consent to participant in the trail and use cisplatin for HIPEC.

Exclusion criteria

Exclusion criteria: 1. Received chemotherapy or radiotherapy before, due to any other reasons; 2. Use cisplatin for any other treatment within 3 weeks after the last cycle of HIPEC; 3. Receive medications that can cause damage to liver or kidney function or lead to bone marrow inhibitation; 4. Allergic to cisplatin.

Design outcomes

Primary

MeasureTime frame
Appearance of dose-limiting toxicity;

Secondary

MeasureTime frame
blood creatine level;evaluation of liver function;degree of bone marrow inhibition;radiological result;

Countries

China

Contacts

Public ContactLi Jing

Sun Yat-Sen Memorial Hospital

jingli.sysu.med@hotmail.com+86 15915893493

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026