GE-PIT Study

Phase 1

Completed

• Conditions: unresectable advanced/recurrent gastric cancer or esophageal cancer

• Registration Number: JPRN-jRCT2080224884
• Lead Sponsor: -

Brief Summary

The combination therapy with an anti-PD-1 antibody drug (nivolumab) and PIT using the investigational drug of ASP-1929 raised no new safety concerns in patients with unresectable advanced/recurrent gastric cancer. As for efficacy, it is considered limited and further investigation is necessary, including pre- and post-treatment development of EGFR and biomarker measurements.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-24
• Study Completion: 2022-05-15
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Inclusion criteria including below but not limited to:
1) Patients with unresectable advanced/recurrent gastric cancer or esophageal cancer that progressed after chemotherapy. This also includes locally advanced cancer.
2) Patients with histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma. Patients with confirmed EGFR-positive if adenocarcinoma.
3) Patients with illuminable primary tumor.
4) Patients with a measurable lesion according to RECIST guideline ver.1.1.
5) Patients aged over 20 years at the time of consent obtaining.
6) Patients applicable to either 0 or 1 in ECOG performance status (PS) within 14 days prior to enrollment.
7) Patients who are judged to have sufficient organ functions based on the laboratory values measured within 14 days before enrollment.
8)Patients with recovered toxicity to CTCAE Grade 1 or lower from prior treatment. Alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia are excluded.
9)Patients received no blood transfusion or no hematopoietic factor preparations including granulocyte-colony-stimulating factor (G-CSF) within 7 days prior to enrollment.
10) Female patients with childbearing potential must be negative for pregnancy test performed within 7 days prior to enrollment.
11) Patients agreed to use adequate contraceptive method during the protocol treatment period and for 6 months after discontinuation of the protocol treatment.
12) Patients with possibility for 3 months or more of survival from the protocol treatment initiation date.
13) Patients whose consent for participation in this study is obtained by a written document by him/herself.

Exclusion Criteria

Exclusion criteria including below but not limited to:
1) Patients determined for a presence of multiorgan invasions of primary tumor.
2) Patients received systemic chemotherapy, anti-PD-1/PD-L1 antibody drug, radiotherapy, surgical operation or hormone therapy within 2 weeks prior to enrolment.
3) Patients received cancer treatment vaccine, treatment with genetically modified virus including virus lytic treatment or genetically modified cellular therapy within 4 weeks prior to enrolment.
4) Patients with serious cardiovascular diseases (congestive heart failure of class 3 or higher in NYHA classification occurred within 6 months prior to enrolment, history of unstable angina or myocardial infraction, or complication with serious arrhythmia).
5) Patients required administration of systemic corticosteroid or immunosuppressant.
Patients receiving hormone replacement therapy (10 mg/day or less of prednisolone equivalent) are excluded.
6) Patients received live vaccine within 30 days prior to the protocol treatment.
7) Patients with complication from active infection that requires systemic treatment.
8) Patients with active multiple cancers. However, patients with asynchronous or synchronous multiple cancer who satisfies either of the following conditions is handled as eligible irrespective of the cancer type, disease stage and treatment history.
Systemic therapy (chemotherapy, immunotherapy, endocrine therapy, etc.) is not needed for at least 6 months after consent obtaining.
Complete cure can be expected with a local therapy such as endoscopic therapy.
9) Patients with complication with poorly controlled autoimmune disease or with history of chronic/recurrent autoimmune disease.
10) Patients with clinical symptoms or imaging findings of active interstitial pneumonia or pulmonary fibrosis.
11) Patients with positive in HIV-1 antibody testing, or who have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with positive in hepatitis B virus (HBV) or hepatitis C virus (HCV) testing, but who have adequate hepatic function and well-controlled disease are not excluded.
12) Patients with history of serious infusion reaction (Grade 3 or higher) against cetuximab.
13) 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.
14) Pregnant or breastfeeding female patients.
15) 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.
16) Patients with a previous experience with using ASP-1929.

Study & Design

• Study Type: Interventional
• Study Design: Not specified