Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
NCT ID: NCT05522231
Last Updated: 2025-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
265 participants
INTERVENTIONAL
2022-10-27
2025-03-31
Brief Summary
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Detailed Description
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A total of about 249-264 patients are planned to be enrolled in the study, among whom about 234 patients are planned to be enrolled in the first part. The patients who are successfully enrolled will be randomly assigned into the investigational arm or the control arm in a 1:1 ratio. The enrollment of part 2 will be started after that of part 1 is completed. About 15\~30 patients are planned to be enrolled in the second part. The patients who are successfully enrolled will receive fruquintinib monotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Investigational arm
fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
fruquintinib+sintilimab
fruquintinib, 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)
axitinib, 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.
axitinib / everolimus
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 monotherapy factorial study
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
fruquintinib
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Interventions
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fruquintinib+sintilimab
fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
axitinib / everolimus
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
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed renal clear cell carcinoma;
3. Patients with locally advanced/metastatic renal carcinoma;
4. Patients with renal carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy for advanced/metastatic disease;
5. At least 1 measurable lesion according to RECIST 1.1;
6. ECOG PS of 0 or 1;
7. Adequate organ function.
Exclusion Criteria
2. Receiving approved systemic anti-tumor therapy within 2 weeks prior to the first dose;
3. 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);
4. Immunosuppression medication within 4 weeks prior to randomization;
5. Patients with active autoimmune or inflammatory diseases;
6. Known central nervous system (CNS) metastasis;
7. History of pneumonitis requiring corticosteroid therapy, or history of or current interstitial lung disease, or current active pulmonary infection, etc.;
8. 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);
9. Human Immunodeficiency Virus (HIV) Infection (HIV 1/2 Antibody positive);
10. Uncontrolled hypertension despite standard therapy;
11. Patient with evidence or history of haemorrhagic tendency within 2 months prior to the first dose, regardless of severity.
18 Years
75 Years
ALL
Yes
Sponsors
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Hutchmed
INDUSTRY
Responsible Party
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Principal Investigators
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Dingwei Ye
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Zhi Song He
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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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
Countries
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Other Identifiers
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2022-013-00CH1
Identifier Type: -
Identifier Source: org_study_id
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