A multicenter prospective randomized controlled clinical study for intraoperative adjuvant photodynamic therapy for malignant soft tissue tumors

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900022153

Enrollment

Unknown

Registered

2019-03-27

Start date

2019-04-01

Completion date

Unknown

Last updated

2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant bone tumors

Interventions

Control group:Standardized surgery was performed routinely

Experimental group:Heimpofen-mediated intraoperative adjuvant photodynamic therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The first diagnosis of malignant soft tissue tumors requires surgical treatment and the expected survival time is more than 6 months, regardless of age and sex. 2. Single-focus tumors have the standard of radical operation, and it is estimated that photodynamic therapy is needed to irradiate the wound area less than 60 cm 2. 3. The AJCC stage of soft tissue sarcoma is stage IIB or earlier than stage IIB, with no more than two recurrences. 4. No local or systemic treatment was given within 2 weeks before enrollment. 5. Voluntarily participate in the clinical study and sign the informed consent. 6. No serious history of heart, lung, liver and kidney diseases. 7. The patient has good compliance.

Exclusion criteria

Exclusion criteria: 1. Surgical excision was found with naked eye remnants. 2. The standardized treatment of tumors includes chemotherapy and radiotherapy. 3. Known patients with skin photoallergy and porphyria. 4. Patients with known allergic history to experimental drugs (porphyrins) and drugs with similar chemical structures. 5. Patients with known severe immunodeficiency or long-term use of glucocorticoids and immunosuppressive agents. 6. Patients with severe heart, liver and kidney diseases (ECG indicated EF = 50%, CRE = 140 umol/L, ALT = 60 U/L, AST = 60 U/L). 7. Patients with hereditary or acquired coagulation disorders. 8. People with severe neurological, psychiatric and endocrine diseases.

Design outcomes

Primary

Measure	Time frame
recurrence free survival, RFS;	—

Secondary

Measure	Time frame
Metastasis rate 3 years after surgery;Overall survival, OS;	—

Countries

China

Contacts

Public ContactZhengdong Cai

Shanghai First People's Hospital

czd856@vip.163.com+86 13901832868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026