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Fruquintinib Plus Everolimus as 2nd Line Therapy of ccRCC Patients Progressed Post IO and TKI Therapy | Clinical Trials | Clareo Health

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Fruquintinib Plus Everolimus as 2nd Line Therapy of ccRCC Patients Progressed Post IO and TKI Therapy

Efficacy and Safety of Fruquintinib in Combination With Everolimus as Second Line Therapy of ccRCC Patients Progressed Post Immunotherapy and Tyrosine Kinase Inhibitors Therapy: a Prospective, Single Arm, Phase II Clinical Trial

NCT06317298•Peking University First Hospital

View on ClinicalTrials.gov

Summary

Detailed Description

This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor. Patients will receive fruquintinib 4mgQd/5mgQd 21days on/7 days off plus everolimus 5mg Qd as the dose escalation phase indicates.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 and ≤75 years of age
•2. Able to Sign informed consent form independently.
•3. Stage IV clear cell renal cell carcinoma.
•4. Subjects must have progressed after IO-TKI therapy.
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
•6. Subjects must have normal organ and marrow function as defined below:
•* Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start;
•* Serum potassium ≥ 3.5 mmol/L;
•* Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine \< 2.0 x ULN.
•8. Allergies to fruquintinib, everolimus or other rapamycin analogues (sirolimus etc), or their excipients;
+16 more criteria

Exclusion Criteria

•1. Have received approved systemic anti-tumor therapy within 2 weeks prior to the first administration, including but not limited to:TKI (TKI with a washout period of 2 weeks or 5 half-lives, whichever is shorter), traditional Chinese medicine treatment (Chinese medicine treatment with anti-tumor indications in the instructions, which can be washed out for 1 week before the first administration), cytokine therapy, etc; Has received any one of the drugs in this study for treatment
•2. Participated in or participated in another intervention clinical study within 4 weeks prior to the first administration, except for an observational (non intervention) clinical study or being in the survival follow-up stage of an intervention study;
•3. Within 60 days prior to the first medication use, significant surgical procedures (such as craniotomy, thoracotomy, or laparotomy, as defined by the researcher) have been performed;
•4. Have undergone any surgery or invasive treatment within 4 weeks prior to the first medication use (fistula surgery requires stable fistula formation for 4 weeks, except for renal/bladder puncture fistula, puncture biopsy, and venous catheterization); Or unhealed wounds, ulcers, fractures, or significant surgery expected during the course of this study (note: local treatment for isolated lesions is acceptable for palliative purposes);
•5. Received radiation therapy within one week before the first medication; Received curative radiotherapy (including over 25% bone marrow radiotherapy) within the first 4 weeks of screening;
•6. Perform close range radiotherapy (such as implanting radiation particles) within 60 days before the first medication;

Locations (1)

Peking University First Hospital

Beijing, China

Key Dates

Start Date

February 21, 2024

Primary Completion Date

August 1, 2025

Completion Date

December 1, 2025

Last Updated

March 19, 2024

Enrollment

ESTIMATED participants

Conditions

Renal Cell Carcinoma, Clear Cell, Somatic

Interventions

Fruquintinib and Everolimus

DRUG

Contacts

Zhisong He, M.D

CONTACT

+8610-83572418 wyj7074@sohu.com

Kaiwei Yang, M.D

CONTACT

13811501435 13811501435@163.com