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

Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 20 人开始时间: 2020年5月20日最近更新: 2023年10月17日

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•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, cT1N2-3,cT2-3N0-3 of adenocarcinoma and cT1N1-3,cT2-3N0-3 of squamous cell carcinoma without distant metastases on cervical-abdominal CT.
•- ECOG Performance Status (PS) is 0 to 1.
•- Radical esophagectomy is not indicated or refused by patient.
•- Definitive chemoradiation is 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.
•- If you have previously received radiotherapy for cervical, thoracic and upper abdominal lesions.

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