A Real-World Observational Study of Intratumoral H101 Oncolytic Adenovirus Combined With Immune Checkpoint Inhibitors for Advanced Metastatic Breast Cancer

Official record

Identifier

NCT07850869

Recruiting locations

country

China

Interventions studied

Not provided in the official record

Lead sponsor

Jie Yuan，MD

Target enrolment

15 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Recruiting

First posted

Sep 30, 2026

Last updated on the registry

Sep 30, 2026

Age

18 Years – 75 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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；
* 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.。

Exclusion Criteria:

* 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);
* 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.

Indexed under

Breast Cancer