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NCT05522231

PHASE2/PHASE3

Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)

Sponsor: Hutchmed

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

265

Start Date

2022-10-27

Completion Date

2025-03

Last Updated

2025-01-03

Healthy Volunteers

Yes

Conditions

Advanced Renal Cell Carcinoma

Interventions

DRUG

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.

DRUG

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.

DRUG

fruquintinib

fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.

Inclusion Criteria: 1. 18 to 75 (inclusive) years of age on the date when ICF was signed; 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: 1. 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; 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.

Locations (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

Clinical Research Directory

Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (48)