Using treprolizumab after surgery for high-risk kidney cancer

A Single-arm Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer Tumors

This study is testing if a new treatment called treprolizumab can help people with high-risk kidney cancer live longer and keep their cancer from coming back after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Second Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation, treprolizumab
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06584435 on ClinicalTrials.gov

What this trial studies

This phase II study investigates the effects of treprolizumab on tumor control and survival in patients with high-risk renal cell carcinoma following radical nephrectomy. Participants will receive treprolizumab every three weeks until tumor recurrence or intolerable side effects occur. The primary outcomes measured will be progression-free survival (PFS) and overall survival (OS). The study aims to determine the efficacy of this treatment approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed stage III/IV renal cell carcinoma who have undergone radical nephrectomy.

Not a fit: Patients with suspected 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 significantly improve survival rates for patients with high-risk renal cancer after surgery.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in renal cancer, suggesting potential for success in this trial.

Eligibility 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 Changyi, MD,PhD — Tianjin Medical University Second Hospital
• Study coordinator: Changyi Quan, MD,PhD

Conditions High-risk Renal Cell Carcinoma; Treprolizumab