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NOT YET RECRUITING
NCT07891377
PHASE2

HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies

Sponsor: Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

A Phase II clinical trial to evaluate the efficacy and safety of different dosing regimens of HEC53856 tablets compared to rHuEPO injection in participants of the CIA trial.

Official title: A Multicenter, Randomized, Open-label, Positive-controlled Phase 2 Clinical Trial of HEC53856 Tablets Versus Recombinant Human Erythropoietin Injection in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-12

Completion Date

2029-05

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

HEC53856 tablet

The experimental cohort is divided into four groups: 20 mg once a day (QD) group, 40 mg QD group, 60 mg QD group, and 100 mg three times a week \[TIW\] group. Participants in the experimental cohort will take HEC53856 tablets orally either in the fasted state or after meals.

DRUG

rHuEPO injection

rHuEPO Injection 36000 IU will be subcutaneously administered once weekly \[QW\].

Locations (1)

Shanghai Chest Hospital

Shanghai, China