Oncolytic Adenovirus Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

H101 is an E1B55KD deleted oncolytic adenovirus, which is the first and only adenovirus to be approved by China State Food and Drug Administration in 2005 for treating head and neck cancer. The objective of this phase II clinical trial is to investigate the safety and efficacy of H101 combined with PD-1 inhibitor Camrelizumab in patients with non-muscle-invasive bladder cancer who failed BCG therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital

Criteria

Inclusion Criteria:

1. Age: 18 ~80 years old.

2. Patients who are diagnosed pathologically with urothelial carcinoma of non-muscle invasive bladder cancer and have previously failed BCG therapy and refused cystectomy.

3. Performance status: Eastern Cooperative Oncology Group performance 0-2.

4. Life expectancy more than 3 months.

5. Patients have adequate organ function, accord with following criteria: A. blood routine: Hemoglobin≥90g/L, absolute neutrophil count≥1.5×10*9/L, platelet count ≥ 80×109/L; B. Biochemical tests: total bilirubin is less than 1.5 times upper limit of normal, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times upper limit of normal; C. creatinine less than 1.25 times upper limit of normal.

6. Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women.

7. Participant sign an institutional review board-approved, protocol specific informed consent form in accordance with institutional guidelines.

Exclusion Criteria:

1. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.

2. Organs failure.

3. ECOG >2.

4. Serious/active infection.

5. Autoimmune disorders or immunodeficiency diseases.

6. Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids.

7. Uncontrolled hypertension.

8. Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia.

9. Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) <50%.

10. Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy.

11. Unhealed wounds, or fractures.

12. With a history of psychotropic drug abuse or mental disorders.

13. Prior systemic therapies with any antitumor agents within 4 weeks.

14. With other uncurable cancers simultaneously.