NCT04761185

Raltitrexed in HIPEC

Phase I Clinical Human Tolerability Test of Raltitrexed in Hyperthermic Intraperitoneal Chemotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the tolerance of patients with colorectal cancer to hyperthermic intraperitoneal chemotherapy with Raltitrexed, to determine the safety, tolerability, PK, and efficacy.

Detailed description

All patients with CRC-PM who underwent CRS at the Department of Colorectal Surgery, Fudan University Shanghai Cancer Center between September 2020 and November 2024 were enrolled as part of the classical 3+3 dose-escalation phase I trial, and within a later expansion cohort. Initially, 3 patients were sequentially evaluated for DLTs at each dose level. The MTD was defined as the highest dose in cohorts where fewer than two of six evaluable patients experienced a DLT. Thereafter, additional patients were enrolled in an expansion cohort to determined the recommended phase II dose (RP2D). The RP2D was selected based on the DLT-defined MTD and the overall safety, tolerability, and supportive PK findings, and was further characterized in an expansion cohort at the candidate dose. The RTX-HIPEC protocol used the classical 3+3 dose escalation method with 7 dose levels (3, 4, 5, 6, 7, 8, 9 mg/m2).

Conditions

• Colorectal Cancer
• Raltitrexed
• HIPEC

Interventions

Type	Name	Description
DRUG	Raltitrexed	The RTX-HIPEC protocol used classical 3+3 dose-escalation method with 7 dose levels (3, 4, 5, 6, 7, 8, 9 mg/m2)

Timeline

• Start date: 2020-09-18
• Primary completion: 2024-12-28
• Completion: 2025-06-30
• First posted: 2021-02-18
• Last updated: 2026-02-25

Locations

1 site across 1 country: China