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

NCT05564897 | Unknown Phase 2

• 1 other identifier: CHUCAS-030
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

Bladder cancer, oncolytic adenovirus, intravesical therapy

Outcome Measures

Primary Outcomes (1)

• complete response (CR)

  CR is deemed by negative cystoscopy, urine cytology, and bladder biopsies.

  One year

Study Arms (1)

Combination of H101 with Camrelizumab treatment

EXPERIMENTAL

Patients receive a combination therapy of PD-1 inhibitor Camrelizumab with oncolytic adenovirus H101 for up to 1 years. Camrelizumab are administered at dose of 200 mg i.v. every 3 weeks. H101 are instilled intravesically with a dose of 5×10\*11 Vp in a 50 mL normal saline solution via a catheter, and dwell time is 1 to 2 hours,. Intravesical H101 is instilled weekly for 6 weeks for both induction and maintenance treatments.

Drug: H101, Camrelizumab

Interventions

H101, Camrelizumab DRUG

Patients receive a combination therapy of Camrelizumab 200 mg i.v. every 3 weeks with intravesical H101 with a dose of 5×10\*11 Vp weekly for 6 weeks for both induction and maintenance treatments up to 1 years.

Combination of H101 with Camrelizumab treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 \~80 years old.
• Patients who are diagnosed pathologically with urothelial carcinoma of non-muscle invasive bladder cancer and have previously failed BCG therapy and refused cystectomy.
• Performance status: Eastern Cooperative Oncology Group performance 0-2.
• Life expectancy more than 3 months.
• 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.
• Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women.
• Participant sign an institutional review board-approved, protocol specific informed consent form in accordance with institutional guidelines.

You may not qualify if:

• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
• Organs failure.
• ECOG \>2.
• Serious/active infection.
• Autoimmune disorders or immunodeficiency diseases.
• Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids.
• Uncontrolled hypertension.
• Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia.
• Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) \<50%.
• Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy.
• Unhealed wounds, or fractures.
• With a history of psychotropic drug abuse or mental disorders.
• Prior systemic therapies with any antitumor agents within 4 weeks.
• With other uncurable cancers simultaneously.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Hua Wang

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Hua Wang, Ph.D.；M.D.

  Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Hua Wang, Ph.D.；M.D.

CONTACT

+86-571-8812-8031; wanghua@zjcc.org.cn

Yedie He, M.D.

CONTACT

+86-571-8812-8031; 525507831@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: August 26, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)