Renal Cell Carcinoma, Clear Cell, SomaticNCT06317298
Fruquintinib Plus Everolimus as 2nd Line Therapy of ccRCC Patients Progressed Post IO and TKI Therapy
A study testing Fruquintinib and Everolimus in people with Renal Cell Carcinoma, Clear Cell, Somatic, run by Peking University First Hospital at 1 site in China.
Trial summary
This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma, Clear Cell, Somatic
- What is being tested?
- Fruquintinib and Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2024to 1 Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- ≥18 and ≤75 years of age
- Able to Sign informed consent form independently.
- Stage IV clear cell renal cell carcinoma.
- Subjects must have progressed after IO-TKI therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Subjects must have normal organ and marrow function as defined below:
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- Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start;
- Serum potassium ≥ 3.5 mmol/L;
- Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine < 2.0 x ULN.
Who cannot join
- Have received approved systemic anti-tumor therapy within 2 weeks prior to the first administration, including but not limited to:TKI (TKI with a washout period of 2 weeks or 5 half-lives, whichever is shorter), traditional Chinese medicine treatment (Chinese medicine treatment with anti-tumor indications in the instructions, which can be washed out for 1 week before the first administration), cytokine therapy, etc; Has received any one of the drugs in this study for treatment
- Participated in or participated in another intervention clinical study within 4 weeks prior to the first administration, except for an observational (non intervention) clinical study or being in the survival follow-up stage of an intervention study;
- Within 60 days prior to the first medication use, significant surgical procedures (such as craniotomy, thoracotomy, or laparotomy, as defined by the researcher) have been performed;
- Have undergone any surgery or invasive treatment within 4 weeks prior to the first medication use (fistula surgery requires stable fistula formation for 4 weeks, except for renal/bladder puncture fistula, puncture biopsy, and venous catheterization); Or unhealed wounds, ulcers, fractures, or significant surgery expected during the course of this study (note: local treatment for isolated lesions is acceptable for palliative purposes);
- Received radiation therapy within one week before the first medication; Received curative radiotherapy (including over 25% bone marrow radiotherapy) within the first 4 weeks of screening;
- Perform close range radiotherapy (such as implanting radiation particles) within 60 days before the first medication;
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- Toxicity caused by previous anti-tumor therapy prior to initial use that has not recovered to the level specified in the American Cancer Society Adverse Event General Terminology (NCI CTCAE) v5.0 ≤ 1 or inclusion criteria;
- Allergies to fruquintinib, everolimus or other rapamycin analogues (sirolimus etc), or their excipients;
- Individuals who have developed other malignant tumors within the 5 years prior to enrollment, excluding clinically cured cervical carcinoma in situ/basal cell carcinoma of the skin/squamous cell carcinoma of the skin/ductal carcinoma in situ of the breast, and localized prostate cancer that has undergone radical treatment;
- Known to have central nervous system (CNS) metastasis and/or spinal cord compression and/or cancerous meningitis, with a history of leptomeningeal carcinoma;
- The known history of liver diseases with clinical significance, including those with active viral hepatitis (when hepatitis B virus surface antigen (HBsAg) and or hepatitis B virus core antibody (HbcAb) are positive, hepatitis B B virus (HBV) DNA>10000 copies/mL or>2000 IU/mL; Hepatitis C virus (HCV) antibody positive and HCV RNA positive, or other active hepatitis with clinically significant moderate to severe cirrhosis;
- The patient currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation; Or those who have a history of gastrointestinal perforation or fistula and have not recovered after surgical treatment;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting surgery within the first 6 months of screening; Congestive heart failure: New York Heart Association (NYHA) grade ≥ 2; Left ventricular ejection fraction (LVEF)<50%;
- The patient currently has uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) even after receiving standardized treatment;
- The patient currently has any disease or condition that affects drug absorption, or the patient is unable to administer the medication orally;
- Patients with evidence of bleeding tendency or medical history within 2 months prior to the first medication (such as black stools, vomiting blood, hemoptysis, bloody stools, etc.), regardless of severity (excluding hemorrhoid bleeding);
- Have a history of arterial thrombosis or deep vein thrombosis within 6 months before the first medication; Or have experienced stroke events and/or transient ischemic attacks within 12 months; Except for patients with thrombosis caused by implantable intravenous infusion pumps or catheters, or those with superficial venous thrombosis who have stabilized after regular anticoagulation treatment;
- During screening, it was found that the tumor invaded large vascular structures, such as pulmonary arteries, superior vena cava, or inferior vena cava, and the researcher determined that there was a significant risk of bleeding;
- May lead to other acute or chronic diseases or abnormal laboratory test values: increase the risk of research participation or drug administration, or interfere with the interpretation of research results, and classify patients as ineligible to participate in this study based on the researcher's judgment;
- Pregnant (positive pregnancy test) or lactating female patients;
- Have a history of interstitial lung disease, non infectious pneumonia, or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc;
- Severe chronic or active infections (including pulmonary tuberculosis infection) that require systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to administration; Patients receiving prophylactic antibiotic treatment (such as for preventing urinary tract infections, chronic obstructive pulmonary disease, or tooth extraction);
- Received live vaccination within 14 days before administration;
- Known history of HIV infection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Zhisong He, MD, +8610-83572418, wyj7074@sohu.com
Kaiwei Yang, MD, 13811501435, 13811501435@163.com
About this study
Official title: Efficacy and Safety of Fruquintinib in Combination With Everolimus as Second Line Therapy of ccRCC Patients Progressed Post Immunotherapy and Tyrosine Kinase Inhibitors Therapy: a Prospective, Single Arm, Phase II Clinical Trial
This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor.
Read the detailed description
This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor. Patients will receive fruquintinib 4mgQd/5mgQd 21days on/7 days off plus everolimus 5mg Qd as the dose escalation phase indicates.
- Being tested
- Fruquintinib and Everolimus
- Keywords
- fruquintinib, everolimus
- 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.
Fruquintinib and EverolimusDrug
Fruquintinib and Everolimus
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib(3mg) plus Everolimus | Experimental | Fruquintinib 3mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events Receives: Drug: Fruquintinib and Everolimus |
| Fruquintinib(4mg) plus Everolimus | Experimental | Fruquintinib 4mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events Receives: Drug: Fruquintinib and Everolimus |
| Fruquintinib(5mg) plus Everolimus | Experimental | Fruquintinib 5mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events Receives: Drug: Fruquintinib and Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD (Maximum Tolerated Dose)
the maximum dose in which the proportion of patients who experience dose limited toxicity (DLT) within 28 days after the first dose level is less than or equal to 1/6. When DLT occurs in patients with a dose level greater than 1/6, a dose level lower than this dose level is considered MTD. The MTD dose group requires at least 6 DLT evaluable patients to be confirmed.
Measured: 6 month
ORR (Objective Response Rate)
Based on the evaluable set of tumor efficacy, it is defined as the sum of the proportions of patients with confirmed complete response (CR) or partial response (PR) as the best overall evaluation per RECIST(Response Evaluation Criteria In Solid Tumors )1.1criteria
Measured: 1 year
Secondary outcomes (2)
PFS (Progression Free Survival)
The time from when the patient starts receiving the study drug until disease progression (according to RECIST 1.1) or death occurs, whichever occurs first
Measured: 1 year
DCR (Decease Control Rate )
The best overall assessment is the sum of the proportions of patients who have confirmed CR, PR, and disease stability (SD) (according to RECIST 1.1)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start21 Feb 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma, Clear Cell, SomaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317298
- Sponsor's protocol ID
- 2023-013-CH01 IIT-RCC
- Status last verified
- Mar 2024
- First submitted
- 5 Dec 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fruquintinib in Combination With Everolimus as Second Line Therapy of ccRCC Patients Progressed Post Immunotherapy and Tyrosine Kinase Inhibitors Therapy: a Prospective, Single Arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06317298
- Acronym / sponsor ID
- 2023-013-CH01 IIT-RCC
- Keywords
- fruquintinib, everolimus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Mar 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.
This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor.
Detailed description
This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor. Patients will receive fruquintinib 4mgQd/5mgQd 21days on/7 days off plus everolimus 5mg Qd as the dose escalation phase indicates.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib(3mg) plus Everolimus | Experimental | Drug: Fruquintinib and EverolimusFruquintinib 3mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events |
| Fruquintinib(4mg) plus Everolimus | Experimental | Drug: Fruquintinib and EverolimusFruquintinib 4mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events |
| Fruquintinib(5mg) plus Everolimus | Experimental | Drug: Fruquintinib and EverolimusFruquintinib 5mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥18 and ≤75 years of age
- Able to Sign informed consent form independently.
- Stage IV clear cell renal cell carcinoma.
- Subjects must have progressed after IO-TKI therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Key exclusion criteria (24 listed)
- Have received approved systemic anti-tumor therapy within 2 weeks prior to the first administration, including but not limited to:TKI (TKI with a washout period of 2 weeks or 5 half-lives, whichever is shorter), traditional Chinese medicine treatment (Chinese medicine treatment with anti-tumor indications in the instructions, which can be washed out for 1 week before the first administration), cytokine therapy, etc; Has received any one of the drugs in this study for treatment
- Participated in or participated in another intervention clinical study within 4 weeks prior to the first administration, except for an observational (non intervention) clinical study or being in the survival follow-up stage of an intervention study;
- Within 60 days prior to the first medication use, significant surgical procedures (such as craniotomy, thoracotomy, or laparotomy, as defined by the researcher) have been performed;
- Have undergone any surgery or invasive treatment within 4 weeks prior to the first medication use (fistula surgery requires stable fistula formation for 4 weeks, except for renal/bladder puncture fistula, puncture biopsy, and venous catheterization); Or unhealed wounds, ulcers, fractures, or significant surgery expected during the course of this study (note: local treatment for isolated lesions is acceptable for palliative purposes);
- Received radiation therapy within one week before the first medication; Received curative radiotherapy (including over 25% bone marrow radiotherapy) within the first 4 weeks of screening;
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 |
|---|---|---|
| Fruquintinib and EverolimusFruquintinib and Everolimus | Drug | Fruquintinib(3mg) plus Everolimus, Fruquintinib(4mg) plus Everolimus, Fruquintinib(5mg) plus Everolimus |
Primary outcome
MTD (Maximum Tolerated Dose)
Time frame: 6 month
the maximum dose in which the proportion of patients who experience dose limited toxicity (DLT) within 28 days after the first dose level is less than or equal to 1/6. When DLT occurs in patients with a dose level greater than 1/6, a dose level lower than this dose level is considered MTD. The MTD dose group requires at least 6 DLT evaluable patients to be confirmed.
ORR (Objective Response Rate)
Time frame: 1 year
Based on the evaluable set of tumor efficacy, it is defined as the sum of the proportions of patients with confirmed complete response (CR) or partial response (PR) as the best overall evaluation per RECIST(Response Evaluation Criteria In Solid Tumors )1.1criteria
2 secondary outcomes
PFS (Progression Free Survival)
Time frame: 1 year
DCR (Decease Control Rate )
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruquintinib and Everolimus in people with Renal Cell Carcinoma, Clear Cell, Somatic, run by Peking University First 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 9 inclusion and 24 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 19 Mar 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.
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 Zhisong He, M.D (+8610-83572418, wyj7074@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (Maximum Tolerated Dose) (time frame: 6 month). The study lists 2 primary outcomes in all. 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 19 Mar 2024.