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

NCT07491783 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-03-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Sichuan Enray Pharmaceutical Sciences Company

    lead OTHER

Principal Investigators

  • Yongsheng Wang · West China Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2027-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07491783 on ClinicalTrials.gov