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A single arm, multicenter, open-label Phase IV clinical trial of the hematoporphyrin injection therapy for malignant tumor and precancerosis in the cavity and superficial parts.

A single arm, multicenter, open-label Phase IV clinical trial of the hematoporphyrin injection therapy for malignant tumor and precancerosis in the cavity and superficial parts.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011128
Enrollment
Unknown
Registered
2017-04-12
Start date
2017-03-31
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Malignant tumor and precancerosis (the cavity or superficial parts) patients

Interventions

A:Hematoporphyrin injection, i.v. Laser therapy after 48-72 hours

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Male and female aged 18 years and more; 2) Patients with malignant tumor or precancerosis who have the detailed, clear case record; 3) Patients that never accept radiotherapy, chemotherapy, or chemotherapy drug withdrawal more than 4 weeks, or suspend radiotherapy in no-PDT- area more than 4 weeks; 4) Patients, with estimated lifetime more than 3 months, can tolerate photodynamic therapy and endoscopic therapy; 5) Patients agree to participate in the trial, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients are allergic to photosensitizers, cicatricial diathesis, or have history of porphyrin metabolic abnormalities; 2. Patients with heart disease whose cardiac function grade beyond?; 3. Patients with diseases of the blood system; 4. Liver and renal insufficiency: 1) The range of serum creatinine which is 1.5 times higher than normal; 2) Without hepatic metastasis, ALT or AST is 2.5 times higher than the normal reference range; With hepatic metastasis, ALT or AST is 5 times higher than the normal reference range (except in situ liver and biliary tract cancer); 3) Serum bilirubin is 1.5 times higher than the normal reference range (except the liver and biliary tract cancer); 5. Patients with tracheoesophageal fistula, or tumor has invaded the major blood vessels; 6. Patients have brain disease or abnormal judgment; 7. Drugs and/or alcohol abusers; 8. Pregnant or lactating women; 9. Patients have weakened immune system, immune inhibition or need glucocorticoid for long-term.

Design outcomes

Primary

MeasureTime frame
Adverse reactions;

Countries

China

Contacts

Public ContactDu Hong

Sichuan Meidu Pharmaceutical Co., Ltd

iduhong@aliyun.com+86 18611916101

Outcome results

None listed

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