Clinical trial NCT06584435: A Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer Tumors
Official title: A Single-arm Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: High-risk Renal Cell Carcinoma
Keywords: Treprolizumab
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II study to investigate the effect of treprolizumab on tumor control and survival in high-risk renal cancer after radical nephrectomy. Patients will be treated with treprolizumab, which will be administered every 3 weeks until tumor recurrence or intolerable toxicities

Detailed description: This is a phase II study to investigate the effect of treprolizumab on tumor control and survival in high-risk renal cancer after radical nephrectomy. Patients will be treated with treprolizumab, which will be administered every 3 weeks until tumor recurrence or intolerable toxicities. The primary outcome measure was PFS and OS.

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

Primary outcomes:
measure: PFS
timeFrame: assessed up to 3 years
measure: OS
timeFrame: assessed up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Changyi Quan
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Second Hospital
name: Changyi Changyi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: