Bladder CancerPhase 2NCT05564897
Oncolytic Adenovirus Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer
A Phase 2 study testing H101, Camrelizumab in people with Bladder Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- H101, Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2022to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hua Wang
Hangzhou, Zhejiang, 310022
Hua Wang, Ph.D.; M.D., +86-571-8812-8031, wanghua@zjcc.org.cn
About this study
Official title: Phase II Single Center Open-Label Single-Arm Study of the Safety and Efficacy of Oncolytic Adenovirus H101 Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer Who Failed BCG Therapy
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.
Read the detailed description
CHUCAS-030 (Cancer Hospital, University of Chinese Academy of Sciences) is a phase II trial conducted at Cancer Hospital, University of Chinese Academy of Sciences in the Zhejiang Province, China. Eligible patients are 18 to 80 years old with non-muscle-invasive bladder cancer who has previously failed BCG therapy and refuse cystectomy. Patients receive a combination therapy of PD-1 inhibitor Camrelizumab with oncolytic adenovirus H101 for up to 1 year. Camrelizumab are administered at dose of 200 mg i.v. every 3 weeks. H101 are instilled intravesically after 14 days from the most recent biopsy and in the absence of any evidence of hematuria with a fixed dose of 5×10*11 Vp in a 50 mL normal saline solution via a catheter, and dwell time is 1 to 2 hours, and patients are encouraged to reposition to maximize bladder surface exposure. Intravesical H101 is instilled weekly for 6 weeks for both induction and maintenance treatments. Patients who experienced unacceptable toxicities or clinical or documented progressive disease are discontinued from the study. The duration of any objective response is measured from the date the initial response is observed to the date that disease progression is observed. Response assessment with cystoscopy, bladder biopsy of visually positive lesions and urine cytology are first evaluated after induction at 3 months. Patients with complete response (CR) at 3 months receive no intervention and are reevaluated at 6 months. Patients with stable disease (SD) receive maintenance treatment at 3 to 4 months. Patients with progressive disease (PD) are deemed non-responders and strongly counseled to reconsider cystectomy or alternative treatment. Patients with CR at 6 months receive maintenance treatment (weekly treatments for 6 weeks). All patients were followed up until death from any cause.
- Conditions
- Bladder Cancer
- Being tested
- H101, Camrelizumab
- Keywords
- Bladder cancer, oncolytic adenovirus, intravesical therapy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H101, CamrelizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: H101, Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response (CR)
CR is deemed by negative cystoscopy, urine cytology, and bladder biopsies.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start26 Aug 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Hua, Zhejiang Cancer Hospital
- Investigators
- Hua Wang, Ph.D.；M.D., Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564897
- Sponsor's protocol ID
- CHUCAS-030
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single Center Open-Label Single-Arm Study of the Safety and Efficacy of Oncolytic Adenovirus H101 Combined With PD-1 Inhibitor in Patients With Non-muscle-invasive Bladder Cancer Who Failed BCG Therapy
- ClinicalTrials.gov ID
- NCT05564897
- Acronym / sponsor ID
- CHUCAS-030
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, oncolytic adenovirus, intravesical therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CHUCAS-030 (Cancer Hospital, University of Chinese Academy of Sciences) is a phase II trial conducted at Cancer Hospital, University of Chinese Academy of Sciences in the Zhejiang Province, China. Eligible patients are 18 to 80 years old with non-muscle-invasive bladder cancer who has previously failed BCG therapy and refuse cystectomy. Patients receive a combination therapy of PD-1 inhibitor Camrelizumab with oncolytic adenovirus H101 for up to 1 year. Camrelizumab are administered at dose of 200 mg i.v. every 3 weeks. H101 are instilled intravesically after 14 days from the most recent biopsy and in the absence of any evidence of hematuria with a fixed dose of 5×10*11 Vp in a 50 mL normal saline solution via a catheter, and dwell time is 1 to 2 hours, and patients are encouraged to reposition to maximize bladder surface exposure. Intravesical H101 is instilled weekly for 6 weeks for both induction and maintenance treatments. Patients who experienced unacceptable toxicities or clinical or documented progressive disease are discontinued from the study. The duration of any objective response is measured from the date the initial response is observed to the date that disease progression is observed. Response assessment with cystoscopy, bladder biopsy of visually positive lesions and urine cytology are first evaluated after induction at 3 months. Patients with complete response (CR) at 3 months receive no intervention and are reevaluated at 6 months. Patients with stable disease (SD) receive maintenance treatment at 3 to 4 months. Patients with progressive disease (PD) are deemed non-responders and strongly counseled to reconsider cystectomy or alternative treatment. Patients with CR at 6 months receive maintenance treatment (weekly treatments for 6 weeks). All patients were followed up until death from any cause.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of H101 with Camrelizumab treatment | Experimental | Drug: H101, CamrelizumabPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H101, CamrelizumabPatients 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. | Drug | Combination of H101 with Camrelizumab treatment |
Primary outcome
complete response (CR)
Time frame: One year
CR is deemed by negative cystoscopy, urine cytology, and bladder biopsies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Wang, Ph.D.；M.D. study chair
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H101, Camrelizumab in people with Bladder Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Wang, Ph.D.；M.D. (+86-571-8812-8031, wanghua@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (CR) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.