- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06211790
Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma
Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma: a Single-center, Prospective, Phase II Umbrella Clinical Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: dingwei ye
- Phone Number: 18121299571
- Email: dwye.li@163.com
Study Contact Backup
- Name: hailiang zhang
- Phone Number: 13524071783
Study Locations
-
-
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Shanghai, China
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Dingwei Ye
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients who meet the following criteria are eligible to participate in the trial:
- 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;
- No previous systemic treatment for the disease;
- ECOG(Eastern Cooperative Oncology Group) PS(performance status) 0-1;
Normal function of major organs (14 days prior to enrollment), i.e. meeting the following criteria:
Blood routine examination criteria should be met (no blood transfusion and no granulocyte colony were received within 14 days before enrollment Stimulator therapy) :
HB 90 g/L or higher The ANC(absolute neutrophil count) acuity 1.5 x 109 / L PLT(platelet count) acuity 100 x 109 / L
- No functional organic disease, the following criteria should be met:
Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥40 mL/min T-bil ≤1.5×ULN upper limit of normal value ALT(Alanine transaminase) and AST≤2.5×ULN If liver metastasis, ALT and AST≤5×ULN
- Expected survival ≥3 months;
- Patients with potential fertility need to use contraception during the study period;
- Patients who volunteered to participate in this study and signed informed consent.
Exclusion Criteria:
Patients with any of the following conditions will be excluded from the trial:
Patients who have received the following medical interventions in the four weeks prior to treatment:
- 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;
- Previously received targeted therapy;
- Definite brain/meningeal metastasis;
- Patients who received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs within 14 days prior to enrollment;
- Any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Severe disturbances (CTCAE, Common Terminology Criteria for Adverse Events> Class 2) occurred within 4 weeks prior to administration of the study drug;Baseline chest imaging suggests active pulmonary inflammation, signs and symptoms of infection (unexplained fever >38.5 degrees) within 14 days prior to first use of the study drug, or the need for oral or intravenous antibiotic treatment;
- Patients with clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to treatment, or with arteriovenous thrombosis events occurring within 6 months prior to treatment;
- Active cardiovascular disease, such as myocardial infarction, severe/unstable angina, or New York Heart Association Class III or IV congestive heart failure, was present in the 6 months prior to treatment.
- Have had other malignancies in the past 5 years (basal cell carcinoma of the skin that has been cured, except carcinoma in situ of the breast and carcinoma in situ of the cervix);
- Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Known to have active tuberculosis;
- HIV antibody positive, active hepatitis B or C (HBV, HCV);
- Is known to be allergic to the investigational drug or any excipients thereof, or has had a severe allergic reaction to other monoclonal antibodies;
- Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures;
- In the investigator's judgment, there is a concomitant medical condition (such as poorly controlled high blood pressure, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FuDan-GP1 subtype
FuDan-GP1 subtype is targeted sensitive type.
Treatment regimen:anlotinib 12 mg PO, QD, 14 days on - 7 days off.
|
Anlotinib (PO, QD), Everolimus (PO, QD) and Tislelizumab (IV, Q3W)
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Experimental: FuDan-GP2 subtype
FuDan-GP2 subtype is Cold tumor type.
Treatment regimen:anlotinib 12 mg PO, QD, 14 days on - 7 days off combined with everolimus 5 mg PO, QD.
|
Anlotinib (PO, QD), Everolimus (PO, QD) and Tislelizumab (IV, Q3W)
|
Experimental: FuDan-GP3 subtype
FuDan-GP3 subtype is progenitor infiltrating type.
Treatment regimen:anlotinib 12 mg PO, QD, 14 days on - 7 days off combined with tislelizumab 200 mg, IV, Q3W.
|
Anlotinib (PO, QD), Everolimus (PO, QD) and Tislelizumab (IV, Q3W)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: 6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: 3 years
|
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)
|
3 years
|
Overall Survival
Time Frame: 3 years
|
OS(overall survival) is defined as the time from the date of randomization to the date of death from any cause.
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Neoplasms, Complex and Mixed
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Adenocarcinoma, Clear Cell
- Adenomyoepithelioma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- MTOR Inhibitors
- Everolimus
- Tislelizumab
Other Study ID Numbers
- Upcoming
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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