A Single-arm, Multicenter, Prospective Clinical Study of Efficacy and Safety of Fruquintinib Combined With Serplulimab in First-line Treatment of Non-clear Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Fruquintinib combined with Serplulimab
- Conditions
- Non-clear Renal Cell Carcinoma
- Sponsor
- RenJi Hospital
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study is design to prospectively investigate the safety and efficacy of Fruquintinib combined with Serplulimab in first-line treatment of non-clear renal cell carcinoma. Fruquintinib, a vascular endothelial growth factor receptor inhibitor, is an anticancer drug independently developed in China to treat refractory metastatic colorectal cancer (mCRC). This is a Single-arm, multicenter, prospective phase 2 clinical study.
Detailed Description
The study is ongoing. This is a single-arm, multicenter clinical study enrolling 39 patients with metastatic or unresectable nccRCC at Renji Hospital and Zhongshan Hospital in Shanghai, China. The study is divided into a safety-run-in stage and a cohort expansion stage. Six patients were enrolled in the safety-run-in stage, and no dose-limited toxicity or treatment-related deaths occurred within the 28-day observation period. Consequently, the cohort was expanded to 39 patients. The treatment includes Fruquintinib 5mg, qd, 2w on/1w off, combined with Serplulimab 4.5mg/kg, IV drip, d1, q3w. Tumor response is evaluated at baseline, every 6 weeks during treatment, and at end-of-treatment visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who have signed an informed consent form and are willing to complete the study according to the protocol;
- •Age between 18 and 75 years old;
- •Patients with metastatic or unresectable nccRCC who have been histologically or cytologically diagnosed (AJCC 8th edition staging);
- •At least one measurable lesion, as required by the "Measurable Lesion" criteria in RECIST 1.1;
- •Not treated with any systemic anti-tumor therapy since diagnosis, including chemotherapy, targeted therapy, and immunotherapy (including but not limited to anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, etc.);
- •Expected survival of 3 months;
- •ECOG score 0-1;
- •Good organ function: meeting the following requirements:
- •Absolute neutrophil count (ANC) ≥1.5× 109/L;
- •Platelet count ≥100×109/L;
Exclusion Criteria
- •There is a history of allergy to any component of the drug SLT or the drug Fruquintinib.
- •A history of or concurrent malignancy (excluding skin basal cell carcinoma and cervical carcinoma in situ and papillary carcinoma of thyroid) that has been cured for more than 5 years and has no active cancer）.
- •Uncontrolled clinical symptoms or diseases of the heart, including: a) NYHA class II or above heart failure; b) unstable angina; c) myocardial infarction within 1 year; d) significant atrial or ventricular arrhythmias requiring clinical intervention.
- •Having received any of the following treatments: a) previous treatment with PD-1, PD-L1 antibodies, or CTLA-4 antibodies; b) received any investigational drugs within 4 weeks prior to the first dose of the study drug; c) enrolled in another clinical trial, unless it is an observational (non-interventional) study; d) requiring systemic treatment with corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within 2 weeks prior to the first dose of the study drug, with the exception of using corticosteroids for local inflammation or prevention of allergies, nausea, and vomiting. Other special circumstances should be communicated with the investigator. In the absence of active autoimmune diseases, inhaled or locally applied steroids and adrenal cortex hormones that replace a dosage of \>10 mg/day prednisone can be used.
- •e) Vaccination with anti-tumor vaccines or receipt of live vaccines within 4 weeks prior to the first dose of the study drug; f) underwent major surgery or had any serious trauma within 4 weeks prior to the first dose of the study drug.
- •Toxicity from previous anti-cancer therapy has not recovered to ≤ CTCAE grade 1 (excluding alopecia and residual neurotoxicity related to previous platinum therapy) or does not meet inclusion/exclusion criteria.
- •Serious infection (CTCAE grade \>2) within 4 weeks prior to the first dose of the study drug, including severe pneumonia, sepsis requiring hospitalization, and infection-related complications; baseline chest imaging shows active pulmonary inflammation, symptoms and signs of infection within 4 weeks of first dose, or the need for oral or intravenous antibiotics.
- •Active autoimmune diseases or a history of autoimmune diseases (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), except autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone and I-type diabetes treated with a stable dose of insulin. Patients with vitiligo or childhood asthma/allergy in remission without any intervention in adulthood are not excluded.
- •A history of immunodeficiency diseases, including HIV-positive, other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation.
- •A history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with steroids), and a history of non-infectious pneumonia.
Arms & Interventions
Fruquintinib combine with Serplulimab
Patients will receive Fruquintinib 5mg, qd, 2w on/1w off, combined with Serplulimab 4.5mg/kg, IV drip, d1, q3w.
Intervention: Fruquintinib combined with Serplulimab
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: Up to 2 years
PFS is defined as the time from the the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Secondary Outcomes
- Objective Response Rate(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Adverse Event(Up to 2 years)