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New treatment option for Renal Cell Carcinoma
Official title Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT05738694
What this study is testing
What is Axitinib plus Toripalimab?
Axitinib plus Toripalimab is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for renal cell carcinoma.
Also referred to as nephrectomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study included 298 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Voluntarily agree to participate in this study and sign the informed consent form;
- Males or females between 18 years old and 80 years old;
- Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
- CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;
- ECOG performance status: 0 or 1 point;
You likely can't join if
- With distant metastasis
- Severe liver and renal dysfunction, combined with other serious diseases;
- Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism)...
- Severe/unstable angina pectoris; uncontrolled hypertension;
- Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;
- Ventricular arrhythmia requiring drug treatment.
See the full eligibility criteria
- Voluntarily agree to participate in this study and sign the informed consent form;
- Males or females between 18 years old and 80 years old;
- Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
- CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;
- ECOG performance status: 0 or 1 point;
- Sufficient heart, bone marrow, liver, and kidney functions: Cardiac function: Cardiac function class 0-2; Blood routine test: WBC≥3.5×10\^9/L, absolute neutrophil count ≥1.5×10\^9/L, PLT≥75.0×10\^9/L, HGB≥80g/L; Liver...
- With distant metastasis
- Severe liver and renal dysfunction, combined with other serious diseases;
- Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;
- Severe/unstable angina pectoris; uncontrolled hypertension;
- Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;
- Ventricular arrhythmia requiring drug treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Guangzhou, China
- Hefei, China
- Shanghai, China
- Sichuan, China
- Tianjin, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Guangzhou, China; Hefei, China; Shanghai, China; Sichuan, China; Tianjin, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.