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

NCT06211790 | Recruiting Phase 2

• 1 other identifier: Upcoming
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Kidney Cancer; Renal Cell Carcinoma; Renal Clear Cell Carcinoma

Outcome Measures

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.

  6 months

Secondary Outcomes (2)

• Progression Free Survival

  3 years

• Overall Survival

  3 years

Study Arms (3)

FuDan-GP1 subtype

EXPERIMENTAL

FuDan-GP1 subtype is targeted sensitive type. Treatment regimen：anlotinib 12 mg PO, QD, 14 days on - 7 days off.

Drug: Anlotinib, Everolimus and Tislelizumab

FuDan-GP2 subtype

EXPERIMENTAL

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.

Drug: Anlotinib, Everolimus and Tislelizumab

FuDan-GP3 subtype

EXPERIMENTAL

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.

Drug: Anlotinib, Everolimus and Tislelizumab

Interventions

Anlotinib, Everolimus and Tislelizumab DRUG

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

FuDan-GP1 subtype; FuDan-GP2 subtype; FuDan-GP3 subtype

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

anlotinib; Everolimus; tislelizumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Central Study Contacts

dingwei ye

CONTACT

18121299571; dwye.li@163.com

hailiang zhang

CONTACT

13524071783

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: patients with renal cell carcinoma will be divided into three types, FuDan-GP1 subtype (targeted sensitive type), FuDan-GP2 subtype (Cold tumor) and FuDan-GP3 subtype (progenitor infiltrating type) in accordance with the condition of response to TKIs and the infiltration of immune cells, which dates from previous protein genomics study published by Nature Communications.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 18, 2024
• Study Start: January 16, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)