NCT06772428

Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery.

A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for Adjuvant Therapy in Patients With High-risk Factor Squamous Cell Carcinoma of the Head and Neck After Surgery.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma) after surgery.

Conditions

• Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors

Interventions

Type	Name	Description
DRUG	Nano-crystalline Megestrol Acetate Oral Suspension	Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy.
RADIATION	standard treatment	radiotherapy ± chemotherapy

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: China