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Phase II Study of Combination Therapy with OBP-301 and Radiotherapy in Patients with Locally Advanced Esophageal Cancer

Phase II Study of Combination Therapy with OBP-301 and Radiotherapy in Patients with Locally Advanced Esophageal Cancer

Oncolys BioPharma Inc.

4-1-28 Toranomon, Minato-ku, Tokyo

tr@oncolys.com

Oncolys BioPharma Inc.

4-1-28 Toranomon, Minato-ku, Tokyo

+81-3-5472-1578

tr@oncolys.com

completed

Mar. 03, 2020

Interventional

multicenter, single-arm, open-label

treatment purpose

2

- The patient was histologically diagnosed with esophageal cancer (squamous cell carcinoma, adenocarcinoma, etc.) by endoscopic biopsy of the primary esophageal lesion, and had a lesion capable of local injection.
- The center of esophageal lesions (primary lesion, intramural metastasis, intraepithelial extension) is located in the thoracic esophagus (8th edition of UICC-TNM). However, if the center of the lesion is more distal than the line 2 cm proximal to the esophagogastric junction (the lower end of the palisade vessels seen endoscopically or the upper edge of the gastric mucosal folds), it is not eligible. Esophageal lesions may be single or multiple.
- In the 8th edition of UICC-TNM, a cT1N1,cT2-3N0-1 of cT1N2,cT2-3N0-2 and adenocarcinoma of squamous cell carcinoma without distant metastases was made.
- ECOG Performance Status (PS) is 0 to 2.
- Radical esophagectomy is not indicated.
- Definitive chemoradiation is not indicated.

- Patients with active double cancers that require treatment (synchronous double cancers and metachronous double cancers with a disease-free interval of less than 3 years).
However, carcinoma in situ, carcinoma of the pharynx, larynx, carcinoma of the skin, and carcinoma of the prostate that does not require treatment, which are not considered to affect prognosis, are not included in active double cancers. Also, a history of a pathologic stage cancer that has been completely resected with a 3-year relative survival of at least 95% or less is not included in the active double cancer.
- The chemotherapy was carried out for esophageal cancer in the past.
- Immune checkpoint inhibitors were used in the past.
- If you have previously received radiotherapy for cervical, thoracic and upper abdominal lesions.

Both

esophageal carcinoma

investigational material(s)
Generic name etc : OBP-301
INN of investigational material : suratadenoturev
Therapeutic category code :
Dosage and Administration for Investigational material : OBP-301 (1x10^12 of VP/mL) is administered endoscopically into tumors three times at approximately 2-week intervals (Day 1,Day 18 and Day 32). The volume of fluid administered per dose should be at least 1 mL to a maximum of 2 mL

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
tumor assessment, observation

safety
efficacy
exploratory
other
tumor assessment, observation, other

Dec. 24, 2019