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NOT YET RECRUITING
NCT07890324
PHASE2

A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia

Sponsor: Jiangsu Guiqiong Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding Phase II clinical study to evaluate the efficacy and safety of SXRN injection in adult patients with cancer-associated anorexia-cachexia. This study comprises a double-blind treatment phase, followed by an open-label treatment phase for eligible participants upon completion of the double-blind period.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-12

Completion Date

2027-12

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DRUG

SXRN Injection

4 mg SXRN injection, intravenous infusion once daily. Dosing schedule: 5 consecutive dosing days followed by a 2-day break within a 21-day cycle. Eligible participants who complete the double-blind phase and meet predefined criteria may enter an open-label treatment phase and receive 4 mg SXRN injection using the same 21-day dosing regimen.

DRUG

SXRN Injection

6 mg SXRN injection, intravenous infusion once daily. Dosing schedule: 5 consecutive dosing days followed by a 2-day break within a 21-day cycle. Eligible participants who complete the double-blind phase and meet predefined criteria may enter an open-label treatment phase and receive 4 mg SXRN injection using the same 21-day dosing regimen.

DRUG

Placebo

Matching placebo, administered by intravenous infusion once daily. Dosing schedule: 5 consecutive dosing days followed by a 2-day break within a 21-day cycle. Eligible participants who complete the double-blind phase and meet predefined criteria may enter an open-label treatment phase and receive 4 mg SXRN injection using the same 21-day dosing regimen.

Locations (1)

National Cancer Center/Cancer Hospital

Beijing, China