Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Sintilimab Versus Axitinib or Everolimus as Second-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (FRUSICA-2)
1 other identifier
interventional
265
1 country
48
Brief Summary
The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. The second part is a fruquintinib monotherapy factorial cohort study to evaluate the efficacy and safety of fruquintinib monotherapy as for second-line treatment of locally advanced or metastatic renal cell carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2022
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedStudy Start
First participant enrolled
October 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJanuary 3, 2025
January 1, 2025
2.2 years
August 16, 2022
January 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Progression free survival (PFS) in Part I
PFS per RECIST 1.1 by BIRC
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Objective response rate (ORR) in Part II
ORR per RECIST 1.1 by investigator
Time from the date of first treatment administration until disease progression or the introduction of a new treatment, assessed up to 20 months.
Secondary Outcomes (9)
PFS
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Safety in Part I
Through study completion, assessed up to 20 months.
Quality of life in Part I
Through study completion, assessed up to 20 months.
Safety in Part II
Through study completion, assessed up to 20 months.
Disease control rate (DCR)
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
- +4 more secondary outcomes
Study Arms (3)
Investigational arm
EXPERIMENTALfruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
Control arm (comparator)
ACTIVE COMPARATORaxitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion ;Everolimus, 10 mg, QD, PO, 3 weeks/cycle.
Fruquintinib monotherapy factorial study
OTHERfruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Interventions
fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
axitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion based on clinical; everolimus, 10 mg, QD, PO, 3 weeks/cycle.
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Eligibility Criteria
You may qualify if:
- to 75 (inclusive) years of age on the date when ICF was signed;
- Histologically or cytologically confirmed renal clear cell carcinoma;
- Patients with locally advanced/metastatic renal carcinoma;
- Patients with renal carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy for advanced/metastatic disease;
- At least 1 measurable lesion according to RECIST 1.1;
- ECOG PS of 0 or 1;
- Adequate organ function.
You may not qualify if:
- Had previously received therapy targeting immune modulatory receptors or related pathways (including but not limited to therapy targeting PD-1, CTLA-4, IDO, PD-L1, LAG-3, TIGIT, IL-2R and GITR, etc, but excluding related cytokine therapy such as IL2), excluding patients who had received immunotherapy such as anti-PD- (L) 1 antibody in adjuvant/neoadjuvant therapy setting and did not progress within 6 months after discontinuation;
- Receiving approved systemic anti-tumor therapy within 2 weeks prior to the first dose;
- Toxicities caused by prior anti-tumor therapy before the first dose that did not recover to Grade 0 or 1 per the NCI CTCAE v5.0 or to the level specified in the enrollment criteria (excluding alopecia and peripheral neurotoxicity ≤ CTCAE Grade 2);
- Immunosuppression medication within 4 weeks prior to randomization;
- Patients with active autoimmune or inflammatory diseases;
- Known central nervous system (CNS) metastasis;
- History of pneumonitis requiring corticosteroid therapy, or history of or current interstitial lung disease, or current active pulmonary infection, etc.;
- Toxicities caused by prior anti-tumor therapy before the first dose that did not recover to Grade 0 or 1 per the National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) v5.0 or to the level specified in the enrollment criteria (excluding alopecia and peripheral neurotoxicities ≤CTCAE Grade 2 caused by platinum-based chemotherapy; thyroid dysfunction with stable disease control after symptomatic treatment);
- Human Immunodeficiency Virus (HIV) Infection (HIV 1/2 Antibody positive);
- Uncontrolled hypertension despite standard therapy;
- Patient with evidence or history of haemorrhagic tendency within 2 months prior to the first dose, regardless of severity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hutchmedlead
Study Sites (48)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
Xiangya Hospital Central South University
Changsha, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
The First Affilated Hospital of Fujian Medical University
Fuzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
Harbin Medical University Cancer Hospital
Ha’erbin, China
Anhui Provincial Hospital
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Qilu Hospital of Shandong University
Jinan, China
Shandong Cancer Hospital & Institute
Jinan, China
Yunnan Cancer Hospital
Kunming, China
Lanzhou University Second Hospital
Lanzhou, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Cancer Hospital
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Guangxi Medical University Cancer Hospital
Nanning, China
Nantong Tumor Hospital
Nantong, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Fudan University Shanghai Cancer Center
Shanghai, China
Renji Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Shanghai General Hospital
Shanghai, China
Zhongshan Hospital Fudan University
Shanghai, China
Liaoning Cancer Hospital & Institution
Shenyang, China
The First Hospital of China Medical University
Shenyang, China
The Second Hospital of Tianjin Medical University
Tianjin, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
The First Affiliated Hospital of Wenzhou medical university
Wenzhou, China
Tongji Hospital Tongji Medical College of HUST
Wuhan, China
Wuhan Union Hospital of China
Wuhan, China
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hosiptal)
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Henan Cancer Hospital
Zhengzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dingwei Ye
Fudan University
- PRINCIPAL INVESTIGATOR
Zhi Song He
Peking University First Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2022
First Posted
August 30, 2022
Study Start
October 27, 2022
Primary Completion
January 1, 2025
Study Completion
March 1, 2025
Last Updated
January 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share