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NOT YET RECRUITING
NCT06722950
PHASE2

Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy

Sponsor: Shandong New Time Pharmaceutical Co., LTD

View on ClinicalTrials.gov

Summary

A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-12

Completion Date

2026-12

Last Updated

2024-12-09

Healthy Volunteers

No

Interventions

DRUG

CAPEOX

CAPEOX: 130mg/m2 of oxaliplatin (D1, central intravenous drip for 2h (time window + 20min)), 1000mg/m2 of capecitabine tablets each time, orally, twice a day (D1-D14, morning and evening); repeat the CAPEOX chemotherapy regimen every 3 weeks.

DRUG

Placebo

Placebo:3 times a day (daily), taken with boiled water.

DRUG

AC591

AC591 : 3 times a day (daily), taken with boiled water.