Clear Cell Renal Cell Cancer (ccRCC)Phase 2NCT07256223
A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread
A Phase 2 study testing Envafolimab+Lenvatinib in people with Clear Cell Renal Cell Cancer (ccRCC) and Liver Metastasis, run by Fudan University.
Trial summary
This is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Cancer (ccRCC), Liver Metastasis
- What is being tested?
- Envafolimab+Lenvatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 May 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
- Subjects must meet all of the following criteria to be eligible for enrollment in the study:
- Provide written informed consent prior to any study-specific procedures.
- Aged between 18 and 75 years, inclusive.
- Histologically confirmed clear cell renal cell carcinoma with radiologically documented liver metastases, and having received no prior systemic antitumor therapy.
- Presence of at least one measurable liver metastasis lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (with the longest diameter ≥ 10 mm on computed tomography scan for non-lymph node lesions).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
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- Life expectancy of ≥ 3 months.
- Voluntarily agree to participate in the study with good compliance.
- Adequate organ and bone marrow function, defined as follows:
- Hematological:Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 70 × 10⁹/L; Hemoglobin (HGB) ≥ 90 g/L.
- Hepatic:Serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; Serum albumin ≥ 28 g/L; Alkaline phosphatase (ALP) ≤ 5 × ULN. (Subjects who meet the above criteria after conventional liver-protecting therapy and remain stable for at least one week, as assessed by the investigator, may be enrolled.)
- Renal:Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 50 mL/min (using the standard Cockcroft-Gault formula).
- Coagulation:International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. (For subjects receiving anticoagulant therapy, enrollment is permitted if the PT and INR are within the therapeutic range intended by the anticoagulant medication.)
Who cannot join
- History of or concurrent other malignancies, except for appropriately treated carcinoma in situ or non-melanoma skin cancer with evidence of cure.
- Prior systemic antitumor therapy for advanced disease (including antiangiogenic agents and immunotherapy), with the exception of palliative radiotherapy or preoperative PD-1 neoadjuvant therapy.
- Presence of metastatic lesions meeting any of the following: unifocal organ metastasis numbering more than 3, or total systemic metastatic foci exceeding 5.
- Known history of hypersensitivity to any component of the investigational drug products.
- Poorly controlled cardiac symptoms or diseases, including: (1) heart failure of New York Heart Association (NYHA) Class II or higher; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- Active infection, or unexplained fever > 38.5°C occurring during the screening period or before the first dose (subjects with fever determined by the investigator to be tumor-related may be enrolled).
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- Administration of live vaccines within 4 weeks prior to the first dose of study treatment or anticipated during the study period.
- History of substance abuse, drug addiction, or chronic alcohol abuse.
- Any condition that, in the judgment of the investigator, would preclude participation in the study. This includes severe concomitant conditions (including psychiatric disorders) requiring treatment, significant laboratory abnormalities, or social/familial factors that could compromise subject safety or adherence to protocol requirements, including data and sample collection
- .
- Active hepatitis B infection.
- Active systemic autoimmune diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Multicenter, Prospective Clinical Study of Envafolimab Combined With Lenvatinib as First-Line Therapy in Renal Cell Carcinoma Patients With Liver Metastases
This is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.
Read the detailed description
The study procedure comprises three phases: a screening period, a treatment period, and a follow-up period. Patients with previously untreated advanced clear cell renal cell carcinoma and liver metastases will be screened. Those who meet the inclusion criteria and provide written informed consent will receive treatment. The treatment regimen consists of envafolimab combined with lenvatinib administered over 8 treatment cycles, with each cycle defined as 14 days. enrolled patients will undergo biopsy of liver metastases before the first dose and after 8 cycles of treatment (or upon confirmation of disease progression). Imaging examinations of the kidneys and liver will be conducted during the screening period, after 4 cycles of treatment, and after 8 cycles of treatment. Following the initiation of therapy, systemic imaging will be performed every 6 months. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Safety evaluations will be based on the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, with relevant laboratory tests performed during each treatment cycle. Adverse events will be recorded from the time of enrollment until 30 days after the last dose. For serious adverse events or those considered related to envafolimab, the recording period will be extended to 90 days after the end of treatment.
- Being tested
- Envafolimab+Lenvatinib
- 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.
Envafolimab+LenvatinibDrug
To evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases.
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab+Lenvatinib | Experimental | Envafolimab+Lenvatinib Receives: Drug: Envafolimab+Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR of liver lesions
Objective Response Rate (ORR) of liver lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: 2 years
Secondary outcomes (3)
DCR of liver lesions
DCR of liver lesions
Measured: 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Measured: 2 years
1-year Overall Survival (OS) rate
1-year Overall Survival (OS) rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion30 May 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 Cancer (ccRCC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256223
- Sponsor's protocol ID
- SMA-RCC-001
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2025
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Prospective Clinical Study of Envafolimab Combined With Lenvatinib as First-Line Therapy in Renal Cell Carcinoma Patients With Liver Metastases
- ClinicalTrials.gov ID
- NCT07256223
- Acronym / sponsor ID
- SMA-RCC-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Huadong Hospital
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 1 Dec 2025 (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 is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.
Detailed description
The study procedure comprises three phases: a screening period, a treatment period, and a follow-up period. Patients with previously untreated advanced clear cell renal cell carcinoma and liver metastases will be screened. Those who meet the inclusion criteria and provide written informed consent will receive treatment. The treatment regimen consists of envafolimab combined with lenvatinib administered over 8 treatment cycles, with each cycle defined as 14 days. enrolled patients will undergo biopsy of liver metastases before the first dose and after 8 cycles of treatment (or upon confirmation of disease progression). Imaging examinations of the kidneys and liver will be conducted during the screening period, after 4 cycles of treatment, and after 8 cycles of treatment. Following the initiation of therapy, systemic imaging will be performed every 6 months. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Safety evaluations will be based on the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, with relevant laboratory tests performed during each treatment cycle. Adverse events will be recorded from the time of enrollment until 30 days after the last dose. For serious adverse events or those considered related to envafolimab, the recording period will be extended to 90 days after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab+Lenvatinib | Experimental | Drug: Envafolimab+LenvatinibEnvafolimab+Lenvatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must meet all of the following criteria to be eligible for enrollment in the study:
- Provide written informed consent prior to any study-specific procedures.
- Aged between 18 and 75 years, inclusive.
- Histologically confirmed clear cell renal cell carcinoma with radiologically documented liver metastases, and having received no prior systemic antitumor therapy.
- Presence of at least one measurable liver metastasis lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (with the longest diameter ≥ 10 mm on computed tomography scan for non-lymph node lesions).
Key exclusion criteria (12 listed)
- History of or concurrent other malignancies, except for appropriately treated carcinoma in situ or non-melanoma skin cancer with evidence of cure.
- Prior systemic antitumor therapy for advanced disease (including antiangiogenic agents and immunotherapy), with the exception of palliative radiotherapy or preoperative PD-1 neoadjuvant therapy.
- Presence of metastatic lesions meeting any of the following: unifocal organ metastasis numbering more than 3, or total systemic metastatic foci exceeding 5.
- Known history of hypersensitivity to any component of the investigational drug products.
- Poorly controlled cardiac symptoms or diseases, including: (1) heart failure of New York Heart Association (NYHA) Class II or higher; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
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 |
|---|---|---|
| Envafolimab+LenvatinibTo evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. | Drug | Envafolimab+Lenvatinib |
Primary outcome
ORR of liver lesions
Time frame: 2 years
Objective Response Rate (ORR) of liver lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
3 secondary outcomes
DCR of liver lesions
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
1-year Overall Survival (OS) rate
Time frame: 2 years
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 9 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab+Lenvatinib in people with Clear Cell Renal Cell Cancer (ccRCC) and Liver Metastasis, run by Fudan University.
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 13 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Sep 2026. 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.
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 Dingwei Ye, MD (+862164175590, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR of liver lesions (time frame: 2 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 9 Sep 2026.