Clear Cell Renal Cell CarcinomaPhase 2NYCRRTNCT06613269
68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.
A Phase 2 study testing 68Ga-NY104 PET/CT, 18F-FDG PET/CT and Radiation Therapy in people with Clear Cell Renal Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- 68Ga-NY104 PET/CT, 18F-FDG PET/CT and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2024to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xianshu Gao, MD, +86 01083575641, gao7777@139.com
Mingwei Ma, MD, +86 0108372408, dr.mingweima@stu.pku.edu.cn
About this study
Official title: Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.
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.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- 68Ga-NY104 PET/CT, 18F-FDG PET/CT, Radiation Therapy, Systemic therapy
- Keywords
- clear cell renal cell carcinoma, CAIX, radiation therapy, 68Ga-NY104
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NY104 PET/CTDrug
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.
18F-FDG PET/CTDrug
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.
Radiation TherapyRadiation
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.
Systemic therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NY104 and FDG guided RT combining systemic therapy | Experimental | In this arm, patients will undergo baseline evaluation using both 68Ga-NY104 and 18F-FGD PET/CT. Metastatic lesions will be identified based on these two PET/CTs and all other imaging modalities available. The radiation field will be planned to cover as much metastasis as possible if not all. Systemic therapy will be delivered at the same time. The patients will be followed up for disease status. Receives: Drug: 68Ga-NY104 PET/CT; Drug: 18F-FDG PET/CT; Radiation: Radiation Therapy; Drug: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival 2, PFS2
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.
Measured: the time from the start of RT to 4 years after treatment
Secondary outcomes (10)
Lesion uptake on 68Ga-NY104 PET/CT
Measured: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT
Lesion uptake on 18F-FDG PET/CT
Measured: 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
Measured: 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
Measured: 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
Measured: From the start of any imaging modality to 1 week after completion of all imaging modalities
Objective response rate
The percentage of patients with complete remission or partial remission of tumor after treatment.
Measured: the time from the start of RT to 4 years after treatment
Progression free survival 1, PFS1
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.
Measured: the time from the start of RT to 4 years after treatment
Disease control rate
The percentage of patients with complete remission, partial remission, or stable disease after treatment.
Measured: the time from the start of RT to 4 years after treatment
Overall survival
Measured: the time from the start of RT to 4 years after treatment
Adverse event
The adverse event due to PET/CT and treatment will be recorded according to CTCAE 5.0.
Measured: the time from the start of RT to 4 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start27 Mar 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613269
- Sponsor's protocol ID
- 2024-413-002
- Acronym
- NYCRRT
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT06613269
- Acronym / sponsor ID
- NYCRRT / 2024-413-002
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- clear cell renal cell carcinoma, CAIX, radiation therapy, 68Ga-NY104
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NY104 and FDG guided RT combining systemic therapy | Experimental | Drug: 68Ga-NY104 PET/CT, Drug: 18F-FDG PET/CT, Radiation: Radiation Therapy, Drug: Systemic therapyIn this arm, patients will undergo baseline evaluation using both 68Ga-NY104 and 18F-FGD PET/CT. Metastatic lesions will be identified based on these two PET/CTs and all other imaging modalities available. The radiation field will be planned to cover as much metastasis as possible if not all. Systemic therapy will be delivered at the same time. The patients will be followed up for disease status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NY104 PET/CT68Ga-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. | Drug | NY104 and FDG guided RT combining systemic therapy |
| 18F-FDG PET/CT18F-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. | Drug | NY104 and FDG guided RT combining systemic therapy |
| Radiation TherapyRadiation 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. | Radiation | NY104 and FDG guided RT combining systemic therapy |
| Systemic therapySystemic 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. | Drug | NY104 and FDG guided RT combining systemic therapy |
Primary outcome
Progression free survival 2, PFS2
Time frame: 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.
10 secondary outcomes
Lesion uptake on 68Ga-NY104 PET/CT
Time frame: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT
Lesion uptake on 18F-FDG PET/CT
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the start of any imaging modality to 1 week after completion of all imaging modalities
Objective response rate
Time frame: the time from the start of RT to 4 years after treatment
Progression free survival 1, PFS1
Time frame: the time from the start of RT to 4 years after treatment
Disease control rate
Time frame: the time from the start of RT to 4 years after treatment
Overall survival
Time frame: the time from the start of RT to 4 years after treatment
Adverse event
Time frame: the time from the start of RT to 4 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-NY104 PET/CT, 18F-FDG PET/CT and Radiation Therapy in people with Clear Cell Renal Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianshu Gao, MD (+86 01083575641, gao7777@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival 2, PFS2 (time frame: the time from the start of RT to 4 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.