Locally advanced or recurrent vulvar cancer, vaginal cancer, or cervical cancer
Conditions
Interventions
Antihistamines and corticosteroids are administered intravenously 30-60 minutes before ASP-1929 infusion as pre-medications.
Following pre-medications, ASP-1929 at a dose of 640 mg/m2 is infused intr
Sponsors
Watari Hidemichi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Patients who are considered not eligible for surgical resection (2) Patients histologically diagnosed with vulvar cancer, vaginal cancer, or cervical cancer (3) Patients in whom EGFR-stained specimens prepared in the "Registry Study on the Actual Treatment Status for Vulvar Cancer, Vaginal Cancer, and Locally Recurrent Cervical Cancer" were used, and who have been confirmed to have EGFR expression (2+ or higher) through central pathological review of this clinical trial (4) Patients previously treated with radiotherapy or chemoradiotherapy to the vulva or the pelvic region. However, in cases of vulvar cancer, patients may be enrolled if the recurrent lesion after surgery is not considered eligible for radiotherapy (5) Patients with cervical cancer who have been treated with one or more chemotherapy regimens (6) Patients with at least one measurable lesion in the vulva, vagina, or cervix, as defined by RECIST v1.1, that is suitable for laser illumination (7) Patients with appropriate organ function, as indicated by laboratory values collected within 28 days before enrollment (8) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale of 0-2 (9) Patients aged 18 years or older at the time of informed consent (10) Patients who can provide written informed consent of their own free will after understanding that they may withdraw consent at any time without disadvantages on future treatment and before undergoing any clinical trial-related procedures (excluding standard medical care)
Exclusion criteria
Exclusion criteria: (1) Patients with active double cancer, in whom the recurrent lesion has been histologically confirmed as not being the target disease of this study (2) Patients with uncontrolled major complications.These include, but are not limited to, critical bleeding or intense pain caused by the tumor, ongoing or active infection, symptomatic congestive heart failure, unstable angina, arrhythmias, or mental illness/social circumstances that may limit adherence to study requirements (3) Patients requiring examinations or treatments expected to be exposed to intense light (ophthalmic examinations or elective surgical procedures not related to the investigational treatment) during the first 4 weeks after ASP-1929 administration (4) Patients with a history of hypersensitivity to any of the ingredients of the drugs used in this study (5)Patients who have received any treatment for the underlying disease within 4 weeks prior to the investigational treatment (6) Pregnant women, women of childbearing potential who cannot agree to use contraception from the time of consent until 7 months after the final dose of the investigational drug, or who cannot agree to refrain from breastfeeding from the time of consent until 2 months after the final dose of the investigational drug (7) Patients with the following distant metastatic disease 1) Solitary or similar lesions in radiation-naive areas indicated for radiotherapy 2) Lesions refractory to other treatments (8) Patients with the following lesions in the illuminated areas (vulva, vagina, or cervix) 1) Mucosal invasion of the rectum and lower urinary tract (bladder and urethra), including fistula formation 2) Suspected invasion of the pelvic wall (including invasion of internal and external iliac vessels and obturator nerve) 3) Suspected invasion reaching the abdominal cavity (9) Patients with cervical cancer who are recommended to receive anti PD-1/PD-L1 drugs (10) Patients deemed ineligible for the investigational drug or considered unable to be safely undergo laser illumination, based on the judgment of the principal investigator or the sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor shrinkage effect in laser-illuminated lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| (Efficacy) Treatment effect in laser-illuminated lesions: local complete response, duration of local disease control, duration of local therapeutic response, Systemic treatment effect: overall response rate, disease control rate, progression-free survival, overall survival, Patient-reported outcomes: pain score, patient QOL (Safety) Adverse events (AEs), Grade 3 or higher AEs, serious AEs and failures | — |
Contacts
Public ContactNaoko Okita
Hokkaido University Hospital
Outcome results
None listed