NCT07491783

Nano-Carbon Iron Suspension Injection Combined With Radiotherapy for Solid Tumors Phase II Clinical Trial

A Multicenter, Open-label Phase II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Intratumoral Injection of Carbon Nanoparticle Iron Suspension (CNSI-Fe) in Combination With Radiotherapy in Patients With Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Sichuan Enray Pharmaceutical Sciences Company · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study Primary Objective: To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors. Study Secondary Objectives: 1. To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy at both injected and non-injected lesions; 2. To evaluate the safety and tolerability of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors; 3. To evaluate the pharmacokinetic (PK) characteristics of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors. Study Population: Patients with histologically or cytologically confirmed solid tumors including soft tissue sarcoma, head and neck squamous cell carcinoma, etc., who are assessed by the investigator as suitable for standard radiotherapy including preoperative neoadjuvant radiotherapy (Cohort A1) or definitive radiotherapy for patients not suitable for surgery (Cohort A2) Study Drug Administration Schedule: Single administration, 2 weeks per administration cycle, total 1-4 cycles Study Primary Endpoint: Objective Response Rate (ORR) assessed according to RECIST 1.1 criteria Study Key Secondary Endpoints: 1. Patients with unresectable locally advanced or advanced solid tumors: Local Control Rate (LCR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Time to Progression (TTP), Time to Response (TTR), and Overall Survival (OS); 2. Patients receiving preoperative neoadjuvant therapy: Major Pathological Response (MPR), Disease-Free Survival (DFS), Disease Control Rate (DCR);

Conditions

• HNSCC
• Soft Tissue Cancer

Interventions

Type	Name	Description
DRUG	Carbon Nanoparticle Iron Suspension for Injection	Dosage Form: Injection Strength: 2 mL: 100 mg Dosage and Administration: Mix 0.5 mL Carbon Nanoparticle Suspension for Injection with 30 mg Iron(II) Sulfate for Injection, administer intratumorally according to the recommended dosage (calculated as Fe²⁺, single dose not exceeding 150 mg) Treatment Schedule: Single administration, 2 weeks per administration cycle, total administration of 1-4 cycles

Timeline

• Start date: 2026-03-27
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: China