Clear Cell Renal Cell Carcinoma
Conditions
Keywords
clear cell renal cell carcinoma, CAIX, radiation therapy, 68Ga-NY104
Brief summary
Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies the investigators have shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, the investigators aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.
Interventions
68Ga-NY104 PET/CT will be performed at baseline, 6 months, 12 months, and 24 months after radiation therapy if the tumor is under control. If CT or MRI shows any suspicious recurrence or metastasis, 68Ga-NY104 PET/CT can be performed at the decision of the urology oncologist or radiation oncologist. The scan begins 1 hour after intravenous injection of 68Ga-NY104.
DRUG18F-FDG PET/CT
18F-FDG PET/CT will be performed at baseline and 6 months after radiation therapy. The scan begins 1 hour after intravenous injection of 18F-FDG.
RADIATIONRadiation Therapy
Radiation therapy will be delivered to cover as much metastasis as possible if not all. For new lesions after radiation plus systemic therapy, if the new lesions are considered suitable for RT, RT can be delivered again without changing systemic therapy.
DRUGSystemic therapy
Systemic therapy will be delivered to patients to control the tumor. Possible regimen includes targeted therapy alone, immunotherapy alone, and targeted therapy combined with immunotherapy. The treatment regimen will be decided according to the urology oncologist.
Sponsors
Peking University First Hospital
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Histologically or cytologically confirmed clear cell renal cell carcinoma * Eligible for radiation therapy: no more than 10 lesions in total * Expected survival: over 3 months * ECOG: 0 or 1 * Sufficient organ function * Written informed consent
Exclusion criteria
* Brain metastasis/carcinomatous meningitis * Other malignant tumors that are not controlled within 5 years, except for non-metastatic low-risk prostate cancer. * Pregnant or breastfeeding. * Active infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival 2, PFS2 | the time from the start of RT to 4 years after treatment | Progression Free Survival 2 (PFS2) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions, when the lesions could not be fully covered by radiotherapy, and the drug regimen had to be changed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion uptake on 18F-FDG PET/CT | From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT | — |
| Number of positive lesions detected on 68Ga-NY104 PET/CT | From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT | — |
| Number of positive lesions detected on 18F-FDG PET/CT | From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT | — |
| Number of lesions detected combining all available imaging modalities | From the start of any imaging modality to 1 week after completion of all imaging modalities | — |
| Lesion uptake on 68Ga-NY104 PET/CT | From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT | — |
| Progression free survival 1, PFS1 | the time from the start of RT to 4 years after treatment | Progression Free Survival 1 (PFS1) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions. |
| Disease control rate | the time from the start of RT to 4 years after treatment | The percentage of patients with complete remission, partial remission, or stable disease after treatment. |
| Overall survival | the time from the start of RT to 4 years after treatment | — |
| Adverse event | the time from the start of RT to 4 years after treatment | The adverse event due to PET/CT and treatment will be recorded according to CTCAE 5.0. |
| Objective response rate | the time from the start of RT to 4 years after treatment | The percentage of patients with complete remission or partial remission of tumor after treatment. |
Countries
China
Contacts
Primary ContactXianshu Gao, MD
Backup ContactMingwei Ma, MD
Outcome results
None listed