Health TrialsbyHealthPanel

Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma

ConditionsKidney CancerRenal Cell CarcinomaRenal Clear Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

Based on different subtypes, subjects will be placed in one of three treatment groups to explore individual efficacy and safety of various treatment regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged 18 and ≤ 75;

Histologically or cytologically confirmed unresectable or metastatic clear cell carcinoma of the kidney, which may contain sarcomatoid lesions;

At least one measurable target lesion at the time of enrollment according to RECIST1.1(Response Evaluation Criteria In Solid Tumors) standards;

Tissue samples are available for testing;

Disqualifiers

Radiation, surgery, chemotherapy, immunotherapy or molecular targeted therapy for tumors

To participate in other clinical studies of drug therapy

Live attenuated vaccine history

Previously received PD-1/PD-L1 monoclonal antibody, CTLA-4 antibody(cytolytic T lymphocyte-associated antigen) or other immunotherapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anlotinib, Everolimus and Tislelizumab

    Drug

    Anlotinib (PO, QD), Everolimus (PO, QD) and Tislelizumab (IV, Q3W)

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: FuDan-GP1 subtypeExperimental treatment 1 intervention
Group B: FuDan-GP2 subtypeExperimental treatment 1 intervention
Group C: FuDan-GP3 subtypeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

ORR(objective response rate) is defined as the proportion of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1.

Time frame
6 months

Secondary outcomes

1

Progression Free Survival

PFS(progression-free survival), defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first)

Time frame
3 years
2

Overall Survival

OS(overall survival) is defined as the time from the date of randomization to the date of death from any cause.

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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