Renal Cell CarcinomaNCT04609293
Observational Study of Camrelizumab Combined With Apatinib and Hyperfractionated Radiotherapy for Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma, run by Peking University First Hospital.
Trial summary
This trial will explore effectiveness and safety using the combination therapy of camrelizumab，apatinib and hyperfractionated radiotherapy in patients with renal cell carcinoma(RCC). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- camrelizumab+apatinib+hyperfractionated radiotherapy
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2020to 7 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Continuous sampling was performed in the Department of Radiotherapy, Peking University First Hospital.
Who may be able to join
- Patients with clear cell renal cell carcinoma were confirmed by histological or cytological;
- Locally advanced/metastatic (the newly diagnosed stage IV RCC assessed by AJCC) or recurrent RCC;
- Have not received or received systemic treatment for first-line advanced HCC (including but not limited to a variety of targeted therapies including TKI, VEGF and mTOR);
- The number of measurable lesion is not more than 5, or although the number of measurable lesion is more than 5, but the radiotherapy department and imaging doctors evaluate that the measurable lesions that can accept radiotherapy are more than or equal to 3;
- According to RECIST 1.1 standard, there will be clinically assessable lesions, and the target lesion has not received radiotherapy before;
- Male or female,from 18 to 75 years;
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- The life expectancy will be longer than 6 months;
- ECOG score will be 0 - 2;
- The main organ functions are normal, and there is no serious blood, heart, lung, liver, kidney dysfunction and immune deficiency diseases. The results of laboratory test must be met the following criteria: Neutrophils: more than 1.5 × 109/L; ; Platelets: more than 100 × 109/L; Hemoglobin: more than 100g/L; serum albumin：more than 30 g/L; bilirubin：less than the upper normal limit (ULN); ALT and AST：less than 2.5 folds of the upper normal limit (ULN)，if there is liver metastasis, ALT and AST must be less than 5 folds of the upper normal limit (ULN) ; Serum Creatinine: less than 1.5×ULN; Blood Urea Nitrogen (BUN): less than 2.5×ULN; Thyroid Stimulating Hormone (TSH): ess than the upper normal limit (ULN)，if abnormal, the T3 and T4 levels should be examined, and the T3 and T4 levels are normal;
- Be willing to comply with research and follow-up procedures;
- Female and male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.Agreeing to participate in this study and signing a written informed consent.
Who cannot join
- Central nervous system metastasis (including brain metastasis, meningeal metastasis, etc.);
- Other immunosuppressive drugs used within 14 days before before study drug administration, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroids (ie not more than 10 mg/day of prednisolone or Other corticosteroids of equivalent pharmacological physiological dose);
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥ 90 mmHg;
- Clinically significant cardiovascular diseases：Myocardial ischemia or myocardial infarction above grade II, ventricular arrhythmia which poorly controlled，QTc>450ms（male）/QTc>470ms (female)；Congestive heart failure (New York heart association (NYHA) class is Ⅲ～Ⅳ)；or cardiac color Doppler ultrasound examination revealed that the left ventricular ejection fraction (LVEF) <50%;
- Accompanied by uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
- Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism;
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- Asthma that requires intermittent use of bronchodilators or other medical intervention should be excluded（Asthma has been completely relieved in childhood, and those without any intervention after adulthood can be included）;
- Coagulation abnormalities (INR>1.5、PT>ULN+4s、APTT >1.5 ULN）, with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
- Proteinuria ≥ (++) and 24 hours total urine protein > 1.0 g;
- Received major surgery or suffered severe traumatic injury, fracture or ulcer within 4 weeks before enrollment;
- Severe infections (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or unexplained fever> 38.5°C during the screening period/before the first administration;
- Clinically significant hemoptysis or more than half a teaspoon (2.5ml) of hemoptysis per day occurred within 2 months before enrollment; or Clinically significant bleeding symptoms or tendency, such as gastrointestinal bleeding, hemorrhagic Gastric ulcer, fecal occult blood≥++ at baseline, or vasculitis, etc.;
- Arterial/venous thrombosis events occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- History of immunodeficiency or human immunodeficiency virus (HIV) infection: HBV DNA>500 IU/ml, HCV RNA>1000copies/ml, HBsAg+ and anti-HCV+；
- Has a known additional malignancy within the last 5 years, exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer;
- The patient is using other research or standard anti-tumor drugs;
- Patients with a clear history of allergies may be potentially allergic or intolerant to camrelizumab and apatinib;
- Patients who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
- Other condition, illness, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or stereotactic radiotherapy administration, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
No sites are listed yet.
About this study
This trial will explore effectiveness and safety using the combination therapy of camrelizumab，apatinib and hyperfractionated radiotherapy in patients with renal cell carcinoma(RCC). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.immunotherapy. hyperfractionated radiotherapy, represented by stereotactic body radiation therapy (SBRT), can significantly improve the radiotherapy sensitivity of RCC. This trial will also observe whether SBRT can bring about immune effects and explore the group and individual indicators that affect the treatment effect of RCC.
Read the detailed description
This trial is a prospective, single-center, observational clinical trial evaluating the combination therapy of camrelizumab，apatinib and hyperfractionated radiotherapy in patients with renal cell carcinoma(RCC). All enrolled patients will receive the following treatments: camrelizumab 200mg every 2 weeks for 1 years combined with apatinib 250mg everyday until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. One week following completion of the second immunotherapy, hypofractionated radiotherapy with marginal dose of 50Gy/2Gy/25f and tumor center dose of local hyperfraction increase 24-32Gy/8-12Gy/3-4f will be performed 3-5 times. The routine radiotherapy will be started at the same time as the third immunotherapy and 25 times routine radiotherapy will be completed before the fifth or sixth immunotherapy.
During treatment participants will be assessed for curative effects and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months to collect survival information and follow-up treatment information. The planned sample size is 30 study participants.
- Conditions
- Renal Cell Carcinoma
- Being tested
- camrelizumab+apatinib+hyperfractionated radiotherapy
- 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.
camrelizumab+apatinib+hyperfractionated radiotherapyCombination product
Immunotherapy, anti-angiogenesis targeted therapy combined with hyperfractionated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+apatinib+Hypofractionated radiation therapy | Camrelizumab:200mg every 2 weeks for 1 years or until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.
Apatinib:250mg everyday until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.
Radiation: one week following completion of the second immunotherapy, hypofractionated radiotherapy with marginal dose of 50Gy/2Gy/25f and tumor center dose of local hyperfraction increase 24-32Gy/8-12Gy/3-4f will be performed 3-5 times. The routine radiotherapy will be started at the same time as the third immunotherapy and 25 times routine radiotherapy will be completed before the fifth or sixth immunotherapy. Receives: Combination Product: camrelizumab+apatinib+hyperfractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate（ORR）
Objective response rate, which is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria.
Measured: 3 years
Secondary outcomes (8)
Subject safety
Number of Adverse Events using NCI CTCAE 5.0
Measured: Date of signing of informed consent form until 12 weeks after the last medication
Progression free survival (PFS)
The date of first treatment until the date of progression using the RECIST 1.1 criteria, or death due to any cause, whichever comes first.
Measured: 3 years
Disease control rate(DCR)
Disease control rate, which is defined as the proportion of subjects who achieve a response of complete response，partial response and stable disease (PR+CR+SD) in the total number of evaluable subjects using the RECIST 1.1 criteria.
Measured: 3 years
Overall Survival(OS)
Overall survival, defined from the date of first treatment to the date of death due to any cause.
Measured: 3 years
Local Control Rate
Local Control Rate, which is defined as the proportion of subjects who achieve a response of remission and stable disease (PR+CR+SD) evaluated by RECIST 1.1 after radiotherapy.
Measured: 3 years
Quality of Life: EORTC QLQ-C30 questionnaire
Quality of life, which will be evaluated using the EORTC（The European Organization for Reasearch and Treatment of Cancer） QLQ-C30（Quality of Life Questionnare-Core 30） questionnaire. The questionnaire contains 30 items. Items 29 and 30 are divided into seven levels, which are counted from 1 to 7 points, 1 is very poor, and 7 is very good. Other items are divided into 4 levels: no at all, a little bit, a lot, and very, and they are directly rated from 1 to 4 points.
Measured: 3 years
Response rate of lesions that did not receive radiotherapy
Response rate of lesions that did not receive radiotherapy, which is defined as the percentage of the number of cases with tumors that have not received radiotherapy in remission and stable disease (PR+CR+SD) in the total number of evaluable cases using the RECIST 1.1 criteria.
Measured: 3 years
Pathology and genetic testing
The pathology of the primary tumor before treatment, the puncture specimen of the tumor after the end of radiotherapy, and the whole exome sequencing of the tumor pathology after the progression + blood ctDNA detection for the patients who agree to the examination.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start20 Oct 2020 (estimated)
- Primary completion7 Sep 2023 (estimated)
- Study completion7 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-shu Gao, Peking University First Hospital
- Investigators
- Xianshu Gao, MD,PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609293
- Sponsor's protocol ID
- 20200903
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Camrelizumab Combined With Apatinib and Hyperfractionated Radiotherapy for Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04609293
- Acronym / sponsor ID
- 20200903
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 20 Oct 2020 (estimated)
- Primary completion
- 7 Sep 2023 (estimated)
- Study completion
- 7 May 2024 (estimated)
- First posted
- 30 Oct 2020 (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.
This trial will explore effectiveness and safety using the combination therapy of camrelizumab，apatinib and hyperfractionated radiotherapy in patients with renal cell carcinoma(RCC). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.immunotherapy. hyperfractionated radiotherapy, represented by stereotactic body radiation therapy (SBRT), can significantly improve the radiotherapy sensitivity of RCC. This trial will also observe whether SBRT can bring about immune effects and explore the group and individual indicators that affect the treatment effect of RCC.
Detailed description
This trial is a prospective, single-center, observational clinical trial evaluating the combination therapy of camrelizumab，apatinib and hyperfractionated radiotherapy in patients with renal cell carcinoma(RCC). All enrolled patients will receive the following treatments: camrelizumab 200mg every 2 weeks for 1 years combined with apatinib 250mg everyday until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. One week following completion of the second immunotherapy, hypofractionated radiotherapy with marginal dose of 50Gy/2Gy/25f and tumor center dose of local hyperfraction increase 24-32Gy/8-12Gy/3-4f will be performed 3-5 times. The routine radiotherapy will be started at the same time as the third immunotherapy and 25 times routine radiotherapy will be completed before the fifth or sixth immunotherapy.
During treatment participants will be assessed for curative effects and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months to collect survival information and follow-up treatment information. The planned sample size is 30 study participants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+apatinib+Hypofractionated radiation therapy | – | Combination Product: camrelizumab+apatinib+hyperfractionated radiotherapyCamrelizumab:200mg every 2 weeks for 1 years or until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Apatinib:250mg everyday until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Radiation: one week following completion of the second immunotherapy, hypofractionated radiotherapy with marginal dose of 50Gy/2Gy/25f and tumor center dose of local hyperfraction increase 24-32Gy/8-12Gy/3-4f will be performed 3-5 times. The routine radiotherapy will be started at the same time as the third immunotherapy and 25 times routine radiotherapy will be completed before the fifth or sixth immunotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Continuous sampling was performed in the Department of Radiotherapy, Peking University First Hospital.
Key inclusion criteria (11 listed)
- Patients with clear cell renal cell carcinoma were confirmed by histological or cytological;
- Locally advanced/metastatic (the newly diagnosed stage IV RCC assessed by AJCC) or recurrent RCC;
- Have not received or received systemic treatment for first-line advanced HCC (including but not limited to a variety of targeted therapies including TKI, VEGF and mTOR);
- The number of measurable lesion is not more than 5, or although the number of measurable lesion is more than 5, but the radiotherapy department and imaging doctors evaluate that the measurable lesions that can accept radiotherapy are more than or equal to 3;
- According to RECIST 1.1 standard, there will be clinically assessable lesions, and the target lesion has not received radiotherapy before;
Key exclusion criteria (19 listed)
- Central nervous system metastasis (including brain metastasis, meningeal metastasis, etc.);
- Other immunosuppressive drugs used within 14 days before before study drug administration, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroids (ie not more than 10 mg/day of prednisolone or Other corticosteroids of equivalent pharmacological physiological dose);
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥ 90 mmHg;
- Clinically significant cardiovascular diseases：Myocardial ischemia or myocardial infarction above grade II, ventricular arrhythmia which poorly controlled，QTc>450ms（male）/QTc>470ms (female)；Congestive heart failure (New York heart association (NYHA) class is Ⅲ～Ⅳ)；or cardiac color Doppler ultrasound examination revealed that the left ventricular ejection fraction (LVEF) <50%;
- Accompanied by uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
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 |
|---|---|---|
| camrelizumab+apatinib+hyperfractionated radiotherapyImmunotherapy, anti-angiogenesis targeted therapy combined with hyperfractionated radiotherapy | Combination product | Camrelizumab+apatinib+Hypofractionated radiation therapy |
Primary outcome
Objective response rate（ORR）
Time frame: 3 years
Objective response rate, which is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria.
8 secondary outcomes
Subject safety
Time frame: Date of signing of informed consent form until 12 weeks after the last medication
Progression free survival (PFS)
Time frame: 3 years
Disease control rate(DCR)
Time frame: 3 years
Overall Survival(OS)
Time frame: 3 years
Local Control Rate
Time frame: 3 years
Quality of Life: EORTC QLQ-C30 questionnaire
Time frame: 3 years
Response rate of lesions that did not receive radiotherapy
Time frame: 3 years
Pathology and genetic testing
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xianshu Gao, MD,PhD principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Peking University First Hospital.
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 11 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingwei Ma, MD (15810160120, 15810160120@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate（ORR） (time frame: 3 years). 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 30 Oct 2020.