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A clinical study on the safety and antitumor activity of autologous HSPPC-96 in the treatment of lung cancer patients

A clinical study on the safety and antitumor activity of autologous HSPPC-96 in the treatment of lung cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107019
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Lung Cancer

Interventions

Experimental group:Screen and enroll patients. The first administration of HSPPC - 96 should be within 8 weeks after surgery (One treatment course is administered per week. Each treatment course consi

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Lung cancer patients (or puncture specimens) who have been fully evaluated clinically for surgery; Subjects voluntarily join the study and sign the informed consent form; 2. Age >=18 years old and =2g), and at least 8 needles of HSPPC-96 can be extracted; 4. KPS score >=70 points; Survival expectancy >=6 months; Good follow-up compliance; 5. Normal bone marrow reserve function and normal liver and kidney function (the following laboratory tests were performed within 7 days before the first treatment with HSPPC-96, confirming that the patient's bone marrow, liver, and kidney function met the requirements for participation in the study): absolute white blood cell value >=2.5×10^9/L; Hemoglobin > 100 g/L; Platelet count > 100×10^9/L; Total bilirubin level < 1.5 x ULN; Alanine aminotransferase/aspartate aminotransferase <2.5 x ULN; Serum creatinine < 1.5 x ULN. 6. Normal cardiac function; 7. No other anti-tumor treatment except surgery within 4 weeks before starting treatment.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Disease recurrence before receiving autologous HSPPC-96 treatment for the first time; 3. Patients with a history of organ transplantation; 4. Patients with uncontrollable infectious diseases or other serious diseases, such as HIV positive, active hepatitis patients; 5. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina pectoris that started in the last 3 months, congestive heart failure, myocardial infarction that occurred within 12 months before enrollment, severe arrhythmias requiring medication, liver, kidney failure, etc.); 6. Patients with systemic autoimmune diseases or immunodeficiency diseases; 7. Patients with allergies; 8. Chronic diseases requiring immunological agents or glucocorticoid therapy; 9. Participated in other clinical trials within the past 30 days.

Design outcomes

Primary

MeasureTime frame
Safety;

Secondary

MeasureTime frame
Progression Free Survival (PFS);Overall Survival (OS );Quality of Life(QOL);Immunological Indices;

Countries

China

Contacts

Public ContactXiao Liang

Shenzhen Second People's Hospital

9179320@qq.com+86 135 5476 4527

Outcome results

None listed

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