Breast Cancer (Locally Advanced or Metastatic)NCT07850869
A Real-World Observational Study of Intratumoral H101 Oncolytic Adenovirus Combined With Immune Checkpoint Inhibitors for Advanced Metastatic Breast Cancer
An observational study of Breast Cancer (Locally Advanced or Metastatic), run by Jie Yuan，MD at 1 site in China.
Trial summary
This prospective, single-center, open-label, real-world observational study plans to enroll 10-15 patients with advanced (Stage IV) breast cancer who have failed multiple prior therapies [aged 18-75, Eastern Cooperative Oncology Group Performance Status Clinical Classification（ECOG） 0-2, with measurable and injectable… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer (Locally Advanced or Metastatic)
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2026to 29 Feb 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll 15 patients with advanced metastatic breast cancer presenting with multiple metastases, who have failed multiple prior lines of systemic therapy, and are aged 18 to 75 years. Subjects will be primarily recruited from the patient population at Foshan Fosun Chancheng Hospital. All eligible subjects must meet all inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Age 18 to 75 years, both genders;
- Pathologically confirmed breast cancer (Stage IV)；
- Disease progression after at least one line of standard systemic therapy；
- ECOG performance status 0-2；
- Intolerant to or refusal of standard chemotherapy；
- At least one radiologically measurable lesion per RECIST 1.1 criteria；
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- At least one lesion amenable to puncture/injection (i.e., accessible for intratumoral injection)；
- Estimated life expectancy ≥3 months；
- Adequate major organ function as defined by the following laboratory values:Absolute neutrophil count (ANC) ≥1.5×10⁹/L,Platelet count (PLT) ≥100×10⁹/L,Hemoglobin (Hb) ≥90 g/L,Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN),Serum creatinine (Cr) ≤1.5× ULN；
- Signed informed consent form；
- Agreement to provide tumor tissue samples and peripheral blood samples before and after treatment for research purposes.。
Who cannot join
- Known allergy to H101 formulation, PD-1 inhibitors, or any of their excipients ;
- Lymphocyte count <0.5×10⁹/L;
- Severe infection, active infection (particularly HBV, HCV, HIV), or severely immunocompromised status;
- Presence of lesions that cannot be safely punctured/injected;
- Prior treatment with PD-1/PD-L1 inhibitors with grade ≥3 immune-related adverse events that have not resolved;
- Concurrent active malignancy other than breast cancer (except for those cured for >5 years with no evidence of recurrence);
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- Uncontrolled brain metastases;
- Pregnant or breastfeeding wome;
- Psychiatric disorders, cognitive impairment, or poor compliance that may interfere with study participation and completion;
- Severe cardiac, hepatic, or renal failure;
- Long-term immunosuppressive therapy;
- Uncontrolled active autoimmune disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jie Yuan contact
China1 site, 1 recruiting
- Recruiting
Foshan Fosun Chancheng Hospital
Guangdong, Foshan
Jie Yuan, Doctoral degree, +86 13016007353, candlewjy@163.com
About this study
This prospective, single-center, open-label, real-world observational study plans to enroll 10-15 patients with advanced (Stage IV) breast cancer who have failed multiple prior therapies [aged 18-75, Eastern Cooperative Oncology Group Performance Status Clinical Classification（ECOG） 0-2, with measurable and injectable lesions]. It aims to preliminarily evaluate the antitumor activity, safety, and immune-microenvironment modulation of intratumoral H101（Recombinant Human Adenovirus Type 5 Injection） oncolytic virus combined with immune checkpoint inhibitors (ICIs) in real-world practice. The regimen is determined by physicians based on clinical status and multidisciplinary input, but follows a standardized framework: 2- to 3-week cycles; H101 injected on day 1 (dose stratified by lesion size), with ICI infusion started 7±2 days later, for 4 planned cycles. Paired tumor biopsies (when feasible) and peripheral blood are collected at baseline and after 4 cycles for single-cell RNA sequencing and immune profiling, focusing on changes in T lymphocyte (T), Natural Killer cell (NK), dendritic, and macrophage subsets and correlating with clinical outcomes. Primary endpoints include adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0（CTCAE v5.0）), objective response and local control rates (Response Evaluation Criteria in Solid Tumors Version 1.1（RECIST 1.1）), 4-cycle completion, and toxicity-related discontinuation. Secondary endpoints include disease control rate, progression-free survival (Kaplan-Meier), and dynamic immune changes. First radiological assessment occurs at 6-8 weeks post-treatment, then every 3 months until progression, loss to follow-up, or 1 year. If re-biopsy is unsafe, only peripheral blood may be collected without protocol violation. Comprehensive follow-up, data confidentiality, and missing-data handling are in place to ensure scientific validity and participant protection.
Read the detailed description
This study is a prospective, single-center, open-label, real-world observational clinical study that plans to enroll 10 to 15 patients with advanced (Stage IV) breast cancer who have failed multiple lines of prior therapy (aged 18-75 years, with ECOG performance status 0-2, and with measurable and injectable tumor lesions). It aims to preliminarily explore the antitumor activity, safety, and impact on the tumor immune microenvironment of intratumoral H101 oncolytic virus injection combined with immune checkpoint inhibitors (ICIs) in a real-world clinical setting. The study does not interfere with routine clinical decisions; the specific combination regimen (H101 intratumoral injection plus an anti-PD-1 or anti-CTLA-4 antibody) is determined by the attending physician based on the patient's condition, prior treatments, and multidisciplinary team recommendations. However, to ensure consistent observation, a standardized treatment framework is established: each cycle lasts 2-3 weeks; on day 1 of each cycle, H101 is injected intratumorally (dose stratified by lesion size according to the package insert, e.g., 5×10¹¹ VP per session with divided injections), and intravenous ICI infusion is started 7±2 days after the first injection, with a planned total of 4 cycles. To analyze biological changes before and after treatment, the study includes a systematic sampling plan: at baseline and after completion of 4 cycles, we attempt to re-biopsy the same accessible lesion whenever possible and also collect peripheral blood. These paired samples will be used for single-cell RNA sequencing and immune microenvironment analysis, focusing on changes in the composition, functional status, and differentially expressed genes of key immune cell subsets (T cells, NK cells, dendritic cells, macrophages), and correlating these changes with clinical efficacy indicators. For efficacy and safety evaluation, the primary endpoints include the incidence and severity of treatment-related adverse events (assessed by CTCAE v5.0), objective response rate and local lesion control rate (by RECIST 1.1), as well as feasibility and tolerability measured by the 4-cycle completion rate and the rate of treatment discontinuation due to toxicity. Secondary endpoints include disease control rate, progression-free survival (estimated using the Kaplan-Meier method for median survival time), and the paired dynamic changes in the above immune microenvironment markers from baseline to post-treatment. For follow-up and data collection, the first radiographic efficacy evaluation is performed 6-8 weeks after treatment completion, and then every 3 months thereafter until disease progression, loss to follow-up, or 1 year. In consideration of real-world operational practicality, if the injected lesion markedly shrinks, becomes necrotic, or cannot be safely re-biopsied after treatment, only peripheral blood samples may be collected without being considered a protocol violation. Comprehensive follow-up management, data confidentiality, and missing data handling measures are also in place to maximize the scientific rigor of the study and safeguard the rights and safety of participants.
- Keywords
- H101 oncolytic virus, immune checkpoint inhibitors, advanced metastatic breast cancer, tumor immune microenvironment, intratumoral injection
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | H101 (Recombinant Human Adenovirus Type 5 Injection)+Anti-Programmed Cell Death Protein 1 Antibody（Anti-PD-1 antibody） ± Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Antibody（anti-CTLA-4 antibody） H101 (Recombinant Human Adenovirus Type 5 Injection) Route of administration: Intratumoral injection Dose: Stratified dosing according to lesion size, using the dose specified in the package insert and the dose based on prior clinical experience (multipoint injection) Frequency: Once per cycle Treatment course: 2-3 weeks per cycle, for a total of 4 cycles Anti-PD-1 antibody ± anti-CTLA-4 antibody Initiation time: 7 ± 2 days after the first H101 injection Administration schedule: Once per cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Metric/method of measurement : Common Terminology Criteria for Adverse Events version 5.0
Measured: From first dose of study treatment through 30 days after the last dose (up to approximately 8-12 weeks)
Objective Response Rate
Response Evaluation Criteria in Solid Tumors version 1.1
Measured: 6-8 weeks after the end of treatment (after completion of 4 treatment cycles)
Local Control Rate
According to clinical and radiological assessment
Measured: Baseline and every 3 months up to 1 year after the end of treatment
Treatment Feasibility
Measured by completion rate and adherence rate
Measured: During the treatment period (up to 4 cycles, each cycle 2-3 weeks)
Tolerability of the study drug in participants
Tolerability will be assessed by the incidence, severity, and relatedness of TEAEs, and the proportion of participants who discontinue treatment due to TEAEs.
Measured: From first dose of study treatment through 30 days after the last dose (up to approximately 8-12 weeks)
Secondary outcomes (2)
Disease Control Rate
Response Evaluation Criteria in Solid Tumors, version 1.1(RECIST 1.1 )
Measured: Baseline and up to approximately 6 months (including 6-8 weeks after the end of treatment)
Progression-Free Survival
According to clinical and radiological assessment
Measured: From first dose of study treatment until disease progression per RECIST v1.1 or death from any cause, whichever occurs first (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start9 Sep 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jie Yuan，MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Yuan，MD, Foshan Fosun Chancheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850869
- Sponsor's protocol ID
- CYEC-LCYJ-2026076-PJ-20260817
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, Individual Participant Data (IPD) will not be shared.
Publications
Lin J, Lin Z, Zhang H, et al.Recombinant human adenovirus type 5 (H101) combined with anti-PD-1 monoclonal antibody in patients with advanced melanoma after immunotherapy failure.J Clin Oncol. 2025 ASCO Annual Meeting Abstract.DOI：10.1200/JCO.2025.43.16_suppl.e21505.
Zhang J, Zhang Q, Liu Z, Wang J, Shi F, Su J, Wang T, Wang F. Efficacy and Safety of Recombinant Human Adenovirus Type 5 (H101) in Persistent, Recurrent, or Metastatic Gynecologic Malignancies: A Retrospective Study. Front Oncol. 2022 Apr 28;12:877155. doi: 10.3389/fonc.2022.877155. eCollection 2022.
PubMed 35574359Zhang Q, Zhang J, Liu Z, Wang J, Wang F, Wang T, Shi F, Su J, Zhao Y. Recombinant Human Adenovirus Type 5 (H101) Intra-Tumor Therapy in Patients with Persistent, Recurrent, or Metastatic Cervical Cancer: Genomic Profiling Relating to Clinical Efficacy. Drug Des Devel Ther. 2023 Nov 27;17:3507-3522. doi: 10.2147/DDDT.S429180. eCollection 2023.
PubMed 38046281Zhao Q, Xiao M, Ma J, Fu C, Gao Q, Bi Y. Reverse resistance to immune checkpoint inhibitor in a patient with recurrent cardia cancer by intratumoral injection of recombinant human adenovirus type 5: a case report and literature review. Front Oncol. 2024 Nov 11;14:1465664. doi: 10.3389/fonc.2024.1465664. eCollection 2024.
PubMed 39588306Duan C, Liu X. Recombinant human adenovirus type 5 administration for the treatment of malignant ascites or pleural effusion in cancer patients: a meta-analysis. Front Oncol. 2025 Sep 17;15:1592995. doi: 10.3389/fonc.2025.1592995. eCollection 2025.
PubMed 41040530Wang ZM, Li MK, Yang QL, Duan SX, Lou XY, Yang XY, Liu Y, Zhong YW, Qiao Y, Wang ZS, Sun L, Qian F. Recombinant human adenovirus type 5 promotes anti-tumor immunity via inducing pyroptosis in tumor endothelial cells. Acta Pharmacol Sin. 2024 Dec;45(12):2646-2656. doi: 10.1038/s41401-024-01349-x. Epub 2024 Jul 19.
PubMed 39030309
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Observational Study of Intratumoral H101 Oncolytic Adenovirus Combined With Immune Checkpoint Inhibitors for Advanced Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07850869
- Acronym / sponsor ID
- CYEC-LCYJ-2026076-PJ-20260817
- Keywords
- H101 oncolytic virus, immune checkpoint inhibitors, advanced metastatic breast cancer, tumor immune microenvironment, intratumoral injection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jie Yuan，MDUniversity, hospital or other
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 30 Sep 2026 (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.
This prospective, single-center, open-label, real-world observational study plans to enroll 10-15 patients with advanced (Stage IV) breast cancer who have failed multiple prior therapies [aged 18-75, Eastern Cooperative Oncology Group Performance Status Clinical Classification（ECOG） 0-2, with measurable and injectable lesions]. It aims to preliminarily evaluate the antitumor activity, safety, and immune-microenvironment modulation of intratumoral H101（Recombinant Human Adenovirus Type 5 Injection） oncolytic virus combined with immune checkpoint inhibitors (ICIs) in real-world practice. The regimen is determined by physicians based on clinical status and multidisciplinary input, but follows a standardized framework: 2- to 3-week cycles; H101 injected on day 1 (dose stratified by lesion size), with ICI infusion started 7±2 days later, for 4 planned cycles. Paired tumor biopsies (when feasible) and peripheral blood are collected at baseline and after 4 cycles for single-cell RNA sequencing and immune profiling, focusing on changes in T lymphocyte (T), Natural Killer cell (NK), dendritic, and macrophage subsets and correlating with clinical outcomes. Primary endpoints include adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0（CTCAE v5.0）), objective response and local control rates (Response Evaluation Criteria in Solid Tumors Version 1.1（RECIST 1.1）), 4-cycle completion, and toxicity-related discontinuation. Secondary endpoints include disease control rate, progression-free survival (Kaplan-Meier), and dynamic immune changes. First radiological assessment occurs at 6-8 weeks post-treatment, then every 3 months until progression, loss to follow-up, or 1 year. If re-biopsy is unsafe, only peripheral blood may be collected without protocol violation. Comprehensive follow-up, data confidentiality, and missing-data handling are in place to ensure scientific validity and participant protection.
Detailed description
This study is a prospective, single-center, open-label, real-world observational clinical study that plans to enroll 10 to 15 patients with advanced (Stage IV) breast cancer who have failed multiple lines of prior therapy (aged 18-75 years, with ECOG performance status 0-2, and with measurable and injectable tumor lesions). It aims to preliminarily explore the antitumor activity, safety, and impact on the tumor immune microenvironment of intratumoral H101 oncolytic virus injection combined with immune checkpoint inhibitors (ICIs) in a real-world clinical setting. The study does not interfere with routine clinical decisions; the specific combination regimen (H101 intratumoral injection plus an anti-PD-1 or anti-CTLA-4 antibody) is determined by the attending physician based on the patient's condition, prior treatments, and multidisciplinary team recommendations. However, to ensure consistent observation, a standardized treatment framework is established: each cycle lasts 2-3 weeks; on day 1 of each cycle, H101 is injected intratumorally (dose stratified by lesion size according to the package insert, e.g., 5×10¹¹ VP per session with divided injections), and intravenous ICI infusion is started 7±2 days after the first injection, with a planned total of 4 cycles. To analyze biological changes before and after treatment, the study includes a systematic sampling plan: at baseline and after completion of 4 cycles, we attempt to re-biopsy the same accessible lesion whenever possible and also collect peripheral blood. These paired samples will be used for single-cell RNA sequencing and immune microenvironment analysis, focusing on changes in the composition, functional status, and differentially expressed genes of key immune cell subsets (T cells, NK cells, dendritic cells, macrophages), and correlating these changes with clinical efficacy indicators. For efficacy and safety evaluation, the primary endpoints include the incidence and severity of treatment-related adverse events (assessed by CTCAE v5.0), objective response rate and local lesion control rate (by RECIST 1.1), as well as feasibility and tolerability measured by the 4-cycle completion rate and the rate of treatment discontinuation due to toxicity. Secondary endpoints include disease control rate, progression-free survival (estimated using the Kaplan-Meier method for median survival time), and the paired dynamic changes in the above immune microenvironment markers from baseline to post-treatment. For follow-up and data collection, the first radiographic efficacy evaluation is performed 6-8 weeks after treatment completion, and then every 3 months thereafter until disease progression, loss to follow-up, or 1 year. In consideration of real-world operational practicality, if the injected lesion markedly shrinks, becomes necrotic, or cannot be safely re-biopsied after treatment, only peripheral blood samples may be collected without being considered a protocol violation. Comprehensive follow-up management, data confidentiality, and missing data handling measures are also in place to maximize the scientific rigor of the study and safeguard the rights and safety of participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | –H101 (Recombinant Human Adenovirus Type 5 Injection)+Anti-Programmed Cell Death Protein 1 Antibody（Anti-PD-1 antibody） ± Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Antibody（anti-CTLA-4 antibody） H101 (Recombinant Human Adenovirus Type 5 Injection) Route of administration: Intratumoral injection Dose: Stratified dosing according to lesion size, using the dose specified in the package insert and the dose based on prior clinical experience (multipoint injection) Frequency: Once per cycle Treatment course: 2-3 weeks per cycle, for a total of 4 cycles Anti-PD-1 antibody ± anti-CTLA-4 antibody Initiation time: 7 ± 2 days after the first H101 injection Administration schedule: Once per cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll 15 patients with advanced metastatic breast cancer presenting with multiple metastases, who have failed multiple prior lines of systemic therapy, and are aged 18 to 75 years. Subjects will be primarily recruited from the patient population at Foshan Fosun Chancheng Hospital. All eligible subjects must meet all inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (11 listed)
- Age 18 to 75 years, both genders;
- Pathologically confirmed breast cancer (Stage IV)；
- Disease progression after at least one line of standard systemic therapy；
- ECOG performance status 0-2；
- Intolerant to or refusal of standard chemotherapy；
Key exclusion criteria (12 listed)
- Known allergy to H101 formulation, PD-1 inhibitors, or any of their excipients ;
- Lymphocyte count <0.5×10⁹/L;
- Severe infection, active infection (particularly HBV, HCV, HIV), or severely immunocompromised status;
- Presence of lesions that cannot be safely punctured/injected;
- Prior treatment with PD-1/PD-L1 inhibitors with grade ≥3 immune-related adverse events that have not resolved;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse Events
Time frame: From first dose of study treatment through 30 days after the last dose (up to approximately 8-12 weeks)
Metric/method of measurement : Common Terminology Criteria for Adverse Events version 5.0
Objective Response Rate
Time frame: 6-8 weeks after the end of treatment (after completion of 4 treatment cycles)
Response Evaluation Criteria in Solid Tumors version 1.1
Local Control Rate
Time frame: Baseline and every 3 months up to 1 year after the end of treatment
According to clinical and radiological assessment
Treatment Feasibility
Time frame: During the treatment period (up to 4 cycles, each cycle 2-3 weeks)
Measured by completion rate and adherence rate
Tolerability of the study drug in participants
Time frame: From first dose of study treatment through 30 days after the last dose (up to approximately 8-12 weeks)
Tolerability will be assessed by the incidence, severity, and relatedness of TEAEs, and the proportion of participants who discontinue treatment due to TEAEs.
2 secondary outcomes
Disease Control Rate
Time frame: Baseline and up to approximately 6 months (including 6-8 weeks after the end of treatment)
Progression-Free Survival
Time frame: From first dose of study treatment until disease progression per RECIST v1.1 or death from any cause, whichever occurs first (up to approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- BackgroundLin J, Lin Z, Zhang H, et al.Recombinant human adenovirus type 5 (H101) combined with anti-PD-1 monoclonal antibody in patients with advanced melanoma after immunotherapy failure.J Clin Oncol. 2025 ASCO Annual Meeting Abstract.DOI：10.1200/JCO.2025.43.16_suppl.e21505.
- Background: PubMed 35574359Zhang J, Zhang Q, Liu Z, Wang J, Shi F, Su J, Wang T, Wang F. Efficacy and Safety of Recombinant Human Adenovirus Type 5 (H101) in Persistent, Recurrent, or Metastatic Gynecologic Malignancies: A Retrospective Study. Front Oncol. 2022 Apr 28;12:877155. doi: 10.3389/fonc.2022.877155. eCollection 2022.
- Background: PubMed 38046281Zhang Q, Zhang J, Liu Z, Wang J, Wang F, Wang T, Shi F, Su J, Zhao Y. Recombinant Human Adenovirus Type 5 (H101) Intra-Tumor Therapy in Patients with Persistent, Recurrent, or Metastatic Cervical Cancer: Genomic Profiling Relating to Clinical Efficacy. Drug Des Devel Ther. 2023 Nov 27;17:3507-3522. doi: 10.2147/DDDT.S429180. eCollection 2023.
- Background: PubMed 39588306Zhao Q, Xiao M, Ma J, Fu C, Gao Q, Bi Y. Reverse resistance to immune checkpoint inhibitor in a patient with recurrent cardia cancer by intratumoral injection of recombinant human adenovirus type 5: a case report and literature review. Front Oncol. 2024 Nov 11;14:1465664. doi: 10.3389/fonc.2024.1465664. eCollection 2024.
- Background: PubMed 41040530Duan C, Liu X. Recombinant human adenovirus type 5 administration for the treatment of malignant ascites or pleural effusion in cancer patients: a meta-analysis. Front Oncol. 2025 Sep 17;15:1592995. doi: 10.3389/fonc.2025.1592995. eCollection 2025.
- Background: PubMed 39030309Wang ZM, Li MK, Yang QL, Duan SX, Lou XY, Yang XY, Liu Y, Zhong YW, Qiao Y, Wang ZS, Sun L, Qian F. Recombinant human adenovirus type 5 promotes anti-tumor immunity via inducing pyroptosis in tumor endothelial cells. Acta Pharmacol Sin. 2024 Dec;45(12):2646-2656. doi: 10.1038/s41401-024-01349-x. Epub 2024 Jul 19.
- Individual participant dataSharing planned: No. No, Individual Participant Data (IPD) will not be shared.
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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.
Jie Yuan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer (Locally Advanced or Metastatic), run by Jie Yuan，MD 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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Yuan, Doctoral degree (+86 13016007353, candlewjy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: From first dose of study treatment through 30 days after the last dose (up to approximately 8-12 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07850869, which also lists 6 linked publications.
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 30 Sep 2026.