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Investigation for the pharmacodynamic characteristics and optimal dosage of Paclitaxel during intraperitoneal hyperthermic chemotherapy (HIPEC)

Investigation for the pharmacodynamic characteristics and optimal dosage of Paclitaxel during intraperitoneal hyperthermic chemotherapy (HIPEC)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026464
Enrollment
Unknown
Registered
2019-10-11
Start date
2019-10-21
Completion date
Unknown
Last updated
2019-10-14

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

Conditions

Gastric Cancer

Interventions

3:Surgery+HIPEC(120mg/m2)
4:Surgery+HIPEC(150mg/m2)
5:Surgery+HIPEC(200mg/m2)
1:Surgery Only
2:Surgery+HIPEC(80mg/m2)
6:Surgery+HIPEC (200mg/m2)

Sponsors

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. ECOG score 1.5 x 10^2/L); Platelet (>100 x 10^9/L); Serum total bilirubin was less than 1.5 times of the upper limit of normal value (ULN), alanine aminotransferase and aspartate aminotransferase were less than 2.5 times of ULN, and creatinine clearance rate was more than 50 ml/min. 7. Negative urinary or serum pregnancy test in women of childbearing age; 8. Projected survival of more than 3 months; 9. I would like to provide blood samples for pharmacokinetic study; 10. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Distant metastasis (e.g. liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.); 2) Peritoneal metastasis, ovarian metastasis or malignant ascites visible to the naked eye; 3) Recurrence of gastric cancer; 4) Primary gastric cancer has been resected; 5) Pregnant or lactating women; reproductive age patients (including men) who refuse to take contraceptive measures; 6) Serious uncontrolled recurrent infections, or HIV infections; 7) replicators of hepatitis B or C virus; 8) Clinically severe (i.e. active) heart disease with myocardial infarction or unstable angina pectoris within 6 months; 9) Uncontrolled diabetes; 10) Medical status (including follow-up and compliance) that may or must interfere with the research process; 11) Allergy to Chemotherapeutic Drugs or Related Drugs.

Design outcomes

Primary

MeasureTime frame
Paclitaxel Contration;Complication rate;

Countries

China

Contacts

Public ContactZhenggang Zhu

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

zzg1954@hotmail.com+86 13611920384

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026