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Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

ConditionsRenal Cell CarcinomaNeoadjuvant
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZHOU FANGJIAN

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Axitinib plus Toripalimab

    Drug

    Preoperative treatment with axitinib will be given for 3 months, 5 mg twice daily, orally. Preoperative treatment with Toripalimab will be given for 4 cycles (3 weeks considered one cycle), 240 mg, Q3W.

  • nephrectomy

    Procedure/Surgery

    nephrectomy

Treatment groups

298 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

disease-free survival (DFS)

To evaluate the efficacy of the neoadjuvant combination of axitinib plus PD-1 in improving the 2-year disease-free survival (DFS) in RCC patients with high-risk for recurrent (T2G3-4 or T3-4, or N1). Disease-free survival (DFS) is defined as time from registration to disease progression or death.

Time frame
2 years

Secondary outcomes

1

The cancer-specific survival (CSS)

cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer.

Time frame
3 years
2

overall survival (OS)

overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause

Time frame
3 years
3

objective response rate (ORR)

CR and PR rate as assessed by RECIST 1.1

Time frame
3 years
4

major pathological response (MPR)

MPR (≤10% viable malignant cells per local pathology assessment)

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ZHOU FANGJIAN

Lead sponsor

Sun Yat-sen University

Sponsor institution

Pfizer

Collaborator

Source ClinicalTrials.gov
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