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Trial Title:
A Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer Tumors
NCT ID:
NCT06584435
Condition:
High-risk Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Tremelimumab
Conditions: Keywords:
Treprolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tremelimumab
Description:
Tremelimumab is administered intravenously at a fixed dose of 240 mg every 3 weeks for 1
treatment cycle until tumor recurrence or intolerable toxic effects.
Arm group label:
High-risk Renal Cell Carcinoma
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Changyi Quan
Address:
City:
Tianjin
Zip:
300211
Country:
China
Status:
Recruiting
Contact:
Last name:
Changyi Quan, PhD
Phone:
13388067990
Email:
345920147@qq.com
Start date:
October 1, 2022
Completion date:
March 3, 2025
Lead sponsor:
Agency:
Tianjin Medical University Second Hospital
Agency class:
Other
Source:
Tianjin Medical University Second Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06584435
