AzTrials
AzTrials

Fumarate Hydratase Deficient Renal Cell CarcinomaPhase 2NCT05877820

A Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in Patients With FHRCC

A Phase 2 study testing Tislelizumab and Lenvatinib in people with Fumarate Hydratase Deficient Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

FHRCC is a rare kind of renal cell carcinoma with a morbidity of 1/2000000 per year.Although several combination therapies demonstrated possible efficacy in this population. No standard treatment has been approved. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Tislelizumab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Jun 2023to 31 Dec 2025
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully understand and voluntarily sign the informed consent form and agree to receive treatment, examination and follow-up as required by the study protocol;
  • Age ≥ 18, < 80 years, male or female;
  • ECOG score ≤2;
  • unresectable or recurrent metastatic FH-deficient renal cell carcinoma not previously treated with systemic antitumor therapy, as confirmed by histology. Prior cytokine therapy is allowed;
  • At least 1 measurable tumor lesion according to RECIST 1.1 criteria. The lesion that has received prior radiotherapy and progressed again is allowed as a target lesion;
  • agree to provide blood and urine samples and previous archived or fresh tumor tissue samples.
  • Demonstrates adequate organ function.
  • Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose. participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of study drug.

Who cannot join

  • Prior treatment with agents targeting VEGF, VEGFR, or mTOR, including but not limited to sunitinib, axitinib, pazopanib, sorafenib, cabozantinib, lenvatinib, bevacizumab, anlotinib, or everolimus;
  • Prior treatment with anti-PD-1, PD-L1 or CTLA-4 antibodies;
  • Participants who are using other investigational agents or who had received investigational drugs <=4 weeks prior to study treatment start;
  • Received major surgery or is recovering from surgery (as judged by the investigator) within 4 weeks;
  • Received Chinese herbal or proprietary Chinese medicine preparation with an antitumor indication within 2 weeks;
  • Requirement of adrenocorticosteroids (>10 mg prednisone or equivalent daily) or other immunosuppressive systemic therapy within 2 week; inhalation of >10 mg prednisone or equivalent daily, but without active autoimmune disease may participate in this study;
Show all 25Show fewer
  • History of organ transplantation or conditions requiring long-term adrenocorticosteroid or immunosuppressive therapy
  • Hypothyroidism, adrenal or pituitary gland function that can be controlled with hormone replacement therapy, type I diabetes mellitus, psoriasis or vitiligo that do not require systemic therapy may be enrolled in the study;
  • Didn't recover from prior antineoplastic therapy, grade 0 to 1 as defined by NCI-CTCAE 5.0 (except alopecia), or levels specified in the inclusion/exclusion criteria. Irreversible toxicity that is not expected to be exacerbated by the study drug can be enrolled;
  • The presence of other malignancies that have progressed or require treatment within 5 years (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or cured carcinoma in situ, such as carcinoma in situ of the breast, prostate cancer: subjects with limited low-risk prostate cancer (≤ T2a, Gleason score ≤ 6, PSA < 10ng/ml) who have received radical treatment and no PSA biochemical (those with recurrence may participate in this study);
  • History of active central nervous system (CNS) metastases or baseline phase imaging showing CNS metastases within 30 days prior to the first dose. Subjects with prior surgical or radiation treatment for brain or meningeal metastases who have maintained clinical stability for ≥ 3 months by screening and have discontinued systemic hormone therapy (dose > 10 mg/day of prednisone or other equivalent hormone) for > 4 weeks may be enrolled. Subjects may be enrolled in this study if the subject's CNS metastases can be treated to meet the requirements of the enrollment criteria and if the subject's CNS symptoms have returned to ≤ grade 1 for at least 2 weeks prior to enrollment (except for residual signs or symptoms related to CNS treatment);
  • Poorly controlled hypertension: SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg;
  • Any one or more of the following cardiovascular disease states within the last 6 months: myocardial infarction; unstable angina; endoluminal angioplasty or coronary stenting; coronary/peripheral artery bypass graft; NYHA cardiac function class 3-4; congestive heart failure; cerebrovascular accident including transient ischemic attack;
  • Heart rate corrected QT interval (QTc) ≥ 480 ms;
  • History of active bleeding or other severe bleeding within 1 month;
  • Deep vein thrombosis or pulmonary embolism within 6 months;
  • Arterial embolism within the last 12 months;
  • Clinically significant gastrointestinal abnormalities, including: malabsorption, total gastrectomy, or any condition that may interfere with the absorption of oral medications; active ulcers treated within 6 months; active gastrointestinal bleeding (vomiting blood, blood in stool, or black stool) within 3 months by endoscopy; metastatic lesions in the gastrointestinal tract suspected of bleeding, inflammatory bowel disease, ulcerative colitis Gastrointestinal perforation or other gastrointestinal disorders that increase the risk of perforation;
  • The presence of (non-infectious) pneumonia/interstitial lung disease requiring adrenocorticosteroid therapy, either previously or currently
  • Presence of active infection requiring systemic therapy, presence of human immunodeficiency virus (HIV) infection (known HIV antibody positivity), presence of active HBV infection (HBsAg positive, or HBcAb positive but HBsAg negative, additional DNA quantification is required and results that do not exceed the upper limit of normal laboratory values can be enrolled), presence of active HCV infection (previous HCV infected patients with negative HCV RNA test results during the screening period can be enrolled);
  • Live virus vaccinations within the last 1 month, including but not limited to mumps, rubella, measles, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccines, excluding inactivated virus vaccines;
  • A history of severe drug allergy, including but not limited to antibody drugs and small molecule targeted drugs;
  • Known psychiatric illness or history of substance abuse;
  • Presence of unhealed wounds;
  • The presence of any medical history or current evidence of disease, treatment or laboratory abnormality that, in the investigator's judgment, could confound the results of the trial, interfere with the subject's participation in the full trial, or is not in the subject's best interest to participate in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ethics Committee of Shanghai Renji Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Prospective, Single Arm Clinical Study to Evaluate Efficacy and Safety of Lenvatinib Combined With Tislelizumab in the First Line Treatment of Patients With Locally Advanced or Metastastic Fumarate Hydratase Deficient Renal Cell Carcinoma

FHRCC is a rare kind of renal cell carcinoma with a morbidity of 1/2000000 per year.Although several combination therapies demonstrated possible efficacy in this population. No standard treatment has been approved. The purpose of this study is to evaluate the efficacy and safety of Lenvatinib in combination with tislelizumab in the first line treatment of patients with locally advanced/metastatic FHRCC.

Keywords
PD-1 checkpoint inhibitor, FHRCC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05877820
Study groupRoleWhat they receive
Tislelizumab+Lenvatinib combination therapyExperimentalParticipants receive tislelizumab 200 mg intravenously every 3 weeks PLUS lenvatinib 20mg orally once daily.
Receives: Biological: Tislelizumab; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.

    Measured: Up to approximately 24 months

Secondary outcomes (7)

  1. Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    PFS was defined as the time from enrollment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

    Measured: Up to approximately 24 months

  2. Overall Survival (OS)

    OS was defined as the time from enrollment to death due to any cause.

    Measured: Up to approximately 24 months

  3. Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months.

    Measured: Up to approximately 24 months

  4. Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first.

    Measured: Up to approximately 24 months

  5. Overall Survival (OS) Rate at Month 12 in All Participants

    The OS rate was determined for all participants at Month 12 and was defined as the time from enrollment to death due to any cause.

    Measured: Month 12

  6. Overall Survival (OS) Rate at Month 24 in All Participants

    The OS rate was determined for all participants at Month 24 and was defined as the time from enrollment to death due to any cause.

    Measured: Month 24

  7. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start1 Jun 2023
  3. Primary completion30 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877820
Sponsor's protocol ID
LENTIS
Status last verified
Sep 2026
First submitted
18 May 2023
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share IPD

Publications

  • Kong W, Xu Y, Liu G, Lv W, Wang Z, Cao D, Jiao F, Hu J, Wu X, Huang J, Chen Y, Zhai W, Wu X, Pan J, Huang Y, Wu G, Zheng L, Xue W, Zhang J. Tislelizumab plus lenvatinib in advanced fumarate hydratase-deficient renal cell carcinoma: a single-arm, phase 2 trial with metabolic biomarker analysis. Nat Commun. 2026 Sep 7;17(1):10591. doi: 10.1038/s41467-026-77615-9.

    PubMed 42844281

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab and Lenvatinib in people with Fumarate Hydratase Deficient Renal Cell Carcinoma, run by RenJi 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 8 inclusion and 25 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: finished, as of the sponsor's last update on 10 Sep 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05877820, which also lists 1 linked publication.

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 10 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in