Combining Tislelizumab and Lenvatinib for Advanced Kidney Cancer
A Single-arm Study of the Efficacy of Tislelizumab Combined With Lenvatinib in Patients With Stage III-IV Renal Cancer
This study is testing if combining two drugs, Tislelizumab and Lenvatinib, can help people with advanced kidney cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Second Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, Tislelizumab, Lenvatinib |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05485883 on ClinicalTrials.gov |
What this trial studies
This phase II study evaluates the safety and efficacy of Tislelizumab in combination with Lenvatinib for patients with advanced kidney cancer (Stage III-IV RCC). Participants will receive these treatments every three weeks until their tumors progress or they experience serious side effects. The primary outcome measure is progression-free survival (PFS), which will help determine the effectiveness of this combination therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed Stage III or IV renal cell carcinoma and no suspected brain metastases.
Not a fit: Patients with brain metastases or those who do not meet the specified organ function criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with advanced kidney cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy and targeted therapy combinations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to provide written informed consent * Age ≥ 18 years * Subjects with pathologically and radiologically confirmed renal cell carcinoma: Stage III/IV * There are no suspected brain metastases * There are lesions that can be measured by imaging * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Organ function level must meet the following requirements: Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=1.5 ULN * Women were required to use an effective contraceptive method for three months after the end of the study, and men were required to consent to use an effective contraceptive method with their spouse during and for three months after the end of the study * The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up Exclusion Criteria: * Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors * Previous or concurrent other malignancy * Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1 * History of primary immunodeficiency * Active, known or suspected autoimmune diseases * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * Pregnant or lactating female patients; * Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions; * Have a clear history of active tuberculosis; * Participating in other clinical researchers; * Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures; * Uncontrolled concurrent diseases, including but not limited to: HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \[i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment\]); Patients with active bleeding or new thrombotic disease
Where this trial is running
Tianjin, Tianjin
- Changyi Quan — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Changyi Quan, MD,PhD — Tianjin Medical University Second Hospital
- Study coordinator: Changyi Quan, MD,PhD
- Email: 345920147@qq.com
- Phone: 13388067990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.