esophageal cancer
Conditions
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria including below but not limited to: 1) Esophageal cancer patients histologically diagnosed with squamous cell carcinoma. 2) Patients in whom the wall invasion depth of esophageal cancer is judged as less than T2 by endoscopy and endoscopic ultrasonography. (in case of patients of Target 1, at the remaining or recurrent lesion). 3) The following patients of Target 1 or Target 2. Target 1:Among esophageal cancer patients with a local remaining or recurrent lesion after chemotherapy(CRT) or radiotherapy(RT), those who meet either of the following conditions: Patients who show a local lesion remaining or recurrent after Laserphyrin photodynamic therap(PDT). Patients who are not targeted in Laserphyrin PDT. Target 2:Esophageal cancer patients intolerant to surgical resection as well as RT, or not wishing either treatment. 4) Patients showing neither lymph node metastasis nor distant metastasis in image by CT at screening. 5) Patients aged greater than 20 years at the time of consent obtaining. 6) Patients whose ECOG performance status (PS) is in the range of 0 to 2 within 14 days before enrollment. 7) Patients from whom written consent to participate in the study is obtained. 8) Patients who are judged to have sufficient organ functions based on laboratory values measured within 14 days before enrollment. 9) Female patients of childbearing potential.
Exclusion criteria
Exclusion criteria: Exclusion criteria including below but not limited to: 1) In case of Target 1, patients in whom aorta invasion of the primary lesion is judged in the CT performed before chemoradiotherapy or radiotherapy 2)(Phase Ib part-1) Patients with lesions with a major axis of 8 cm or more, or tumors with a thickness of 1 cm or more, as determined by endoscopic examination and endoscopic ultrasound during screening. (Phase Ib part-2) Patients with lesions with a major axis of 5 cm or more, or lesions with circumferential involvement of 3/4 or more, or tumors with a thickness of 1 cm or more, as determined by endoscopic examination and endoscopic ultrasound during screening. 3)(Phase Ib part-2) Patients with esophageal stenosis due to previous treatment. 4) Patients with active multiple cancers. However, patients with asynchronous or synchronous multiple cancer who doesn't require systemic therapy for at least 6 months after consent obtaining, or on whom complete cure can be expected with a local therapy such as endoscopic therapy, is handled as eligible. 5) Patients with a poorly controlled severe complication. 6) Patients with an uncontrolled infection. 7) Patients with a history of significant infusion reaction (greater than Grade 3) to cetuximab 8) Patients who had received chemotherapy, administration of cetuximab or RT within 4 weeks before enrollment. 9) Patients needing ophthalmological examination or surgical operation etc., in which exposure to strong light is foreseeable, within 4 weeks after administration of the investigational drug. 10) Pregnant or breastfeeding female patients. 11) Patients who are judged by the principal investigator as ineligible to be administered the investigational drug, or in whom the principal investigator judges that laser illumination cannot be performed safely. 12) Patients who have experienced RM-1929 or ASP-1929 against esophageal cancer in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy 1) Incidence rate of illumination dose-limiting toxicity 2) Rate of local complete response (L-CR) judged centrally | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics 1) Rate of L-CR judged centrally 2) PK of ASP-1929, cetuximab and IR700 3) ADA expression 4) Incidence rate of adverse event (incidence rate of adverse event judged according to CTCAE Version 5.0) 5) Incidence rate of device deficiencies (laser equipment) 6) Rate of L-CR judged by the principal investigator or sub-investigator 7)L-PFS 8)PFS 9)OS | — |
Countries
Japan
Contacts
Public ContactSecretariat of clinical trial coordinating committ
National Cancer Center Hospital East
Outcome results
None listed