Combination therapy of PDT with Talporfin and nivolumab in patients with advanced oesophageal squamous cell carcinoma

JRCT ID: jRCT1041200029

Registered date:09/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: esophageal cancers
• Date of first enrollment: 23/04/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Photodynamic therapy (PDT) is performed. Nivolumab (3 mg/kg) is started within 14 dyas after the PDT. Nivolumab is administrated intravenously every 2 weeks.

Outcome(s)

• Primary Outcome: Progression-free survival; PFS

Secondary Outcome

1) Overall survival; OS
2) best overall response; BOR
3) overall response rate; ORR
4) time to response; TTR
5) duration of response; DOR
6) disease control rate; DCR

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) age > 20 years old
2) failure after chemoradiotherapy esophageal cancer
3) one week or longer from the last treatment for esophageal cancer
4) histologically proven esophageal cancer
5) at least 1 measurable or non-measurable lesion per the RECIST Guideline
6) no invasion to the cervical esophagus
7) Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2
8) adequate organ functions (white blood cell counts >2000 /mm3, neutrophils >1000 /mm3, hemoglobin >8.0g/dL, platelet count >75000/ mm3, serum total bilirubin level <3.0 mg/dL, both alanine transferase and aspartate aminotransferase <100IU/L, Creatinine <2.0mg/dL)
9) provision of written informed consent

Exclude criteria

1) significant diseases
uncontrolled hypertension
uncontrolled diabetes mellitus
severe liver cirrhosis
significant cardiovascular diseases (myocardial infarction, unstable angina, congestive heart failure)
severe renal disorder
2) a current or past history of interstitial lung disease or pulmonary fibrosis
3) systemic infection requiring antibiotics
4) inability to comply the sun shade restrictions
5) baseline lesions before CRT that were judged to involve the aorta
6) porphyria
7) preexisting condition of sun photosensitivity
8) for women, pregnancy or lactation
9) unwillingness to use contraception
10) severe bleeding or shock status
11) bleeding tendency
12) current participation or prior participation within 3 months in other clinical trials for unapproved and off-label drugs or medical devices
13) patients who judged by the investigator that enrollment was inappropriate

Related Information

• Primary Sponsor: TANAKA MAMORU