A Phase I/II clinical trial of Carbon-ion radiotherapy for patients with immune checkpoint inhibitor resistant metastatic renal cell carcinoma

JRCT ID: jRCT1032190111

Registered date:07/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Renal cell carcinoma
• Date of first enrollment: 07/10/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Carbon-ion radiotherapy

Outcome(s)

• Primary Outcome: Adverse event
• Secondary Outcome: Local control rate, local shrinkage rate, occurrence rate of Abscopal effect, progression free survival rate, overall survival rate

Key inclusion & exclusion criteria

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

Include criteria

1) Immune checkpoint inhibitor resistant metastatic renal cell carcinoma diagnosed by urologist
2) Age >20 years
3) Performance Status (ECOG), 0-2
4) Ability to understand and sign an informed consent form at each institution

Exclude criteria

1) target tumors that had been treated by other radiation therapies
2) an estimated life expectancy of less than 6 months
3) the presence of active double cancers other than RCC
4) Existing untreatable infection or inflammatory disease in target volume
5) a serious medical or psychological condition precluding safe administration of treatment

Related Information

• Primary Sponsor: Kasuya Goro