Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06211790

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

Led by Fudan University · Updated on 2024-01-18

66

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 75 years
  • Histologically or cytologically confirmed unresectable or metastatic clear cell carcinoma of the kidney, possibly with sarcomatoid lesions
  • At least one measurable target lesion per RECIST 1.1 criteria
  • Available tissue samples for testing
  • No prior systemic treatment for the disease
  • Eastern Cooperative Oncology Group performance status 0-1
  • Normal major organ function within 14 days prior to enrollment, including specified blood counts and liver/kidney function
  • Expected survival of 3 months or more
  • Use of contraception if of potential fertility
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Received radiation, surgery, chemotherapy, immunotherapy, or targeted therapy within 4 weeks prior to treatment
  • Participation in other clinical drug studies within 4 weeks prior to treatment
  • History of live attenuated vaccine within 4 weeks prior to treatment
  • Prior treatment with PD-1/PD-L1 or CTLA-4 antibodies or other immunotherapy
  • Prior targeted therapy
  • Definite brain or meningeal metastasis
  • Systemic corticosteroid or immunosuppressive therapy within 14 days prior to enrollment
  • Active autoimmune disease or history of autoimmune disease, or history of allogeneic transplantation
  • Severe adverse events within 4 weeks prior to study drug administration
  • Active pulmonary infection or inflammation within 14 days prior to study drug
  • Clinically significant bleeding or bleeding tendency within 3 months, or thrombosis within 6 months prior to treatment
  • Active cardiovascular disease within 6 months prior to treatment
  • Other malignancies in past 5 years except certain skin or in situ carcinomas
  • Conditions affecting oral medication intake
  • Active tuberculosis
  • HIV positive or active hepatitis B or C infection
  • Allergy to study drugs or severe reactions to monoclonal antibodies
  • Pregnant or lactating women, or women not using reliable contraception
  • Any medical condition endangering safety or study completion as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

D

dingwei ye

CONTACT

H

hailiang zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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