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

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

October 27, 2022

Primary Completion Date

January 31, 2025

Study Completion Date

March 31, 2025

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.

Trial Locations (48)

Unknown

Beijing Chao-Yang Hospital, Capital Medical University, Beijing

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Peking Union Medical College Hospital, Beijing

Peking University First Hospital, Beijing

Peking University Third Hospital, Beijing

The First Affiliated Hospital of Bengbu Medical College, Bengbu

The First Hospital of Jilin University, Changchun

Hunan Cancer Hospital, Changsha

Xiangya Hospital Central South University, Changsha

Sichuan Provincial People's Hospital, Chengdu

West China Hospital of Sichuan University, Chengdu

Chongqing University Cancer Hospital, Chongqing

The First Affilated Hospital of Fujian Medical University, Fuzhou

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

Sun Yat-sen University Cancer Center, Guangzhou

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

The First Affiliated Hospital, Zhejiang University, Hangzhou

Harbin Medical University Cancer Hospital, Ha’erbin

Anhui Provincial Hospital, Hefei

The First Affiliated Hospital of Anhui Medical University, Hefei

Qilu Hospital of Shandong University, Jinan

Shandong Cancer Hospital & Institute, Jinan

Yunnan Cancer Hospital, Kunming

Lanzhou University Second Hospital, Lanzhou

The First Affiliated Hospital of Nanchang University, Nanchang

Jiangsu Cancer Hospital, Nanjing

Jiangsu Province Hospital, Nanjing

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing

Guangxi Medical University Cancer Hospital, Nanning

Nantong Tumor Hospital, Nantong

The Affiliated Hospital of Qingdao University, Qingdao

Fudan University Shanghai Cancer Center, Shanghai

Renji Hospital,Shanghai Jiaotong University School of Medicine, Shanghai

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

Shanghai General Hospital, Shanghai

Zhongshan Hospital Fudan University, Shanghai

Liaoning Cancer Hospital & Institution, Shenyang

The First Hospital of China Medical University, Shenyang

The Second Hospital of Tianjin Medical University, Tianjin

Tianjin Medical University Cancer Institute & Hospital, Tianjin

The First Affiliated Hospital of Wenzhou medical university, Wenzhou

Tongji Hospital Tongji Medical College of HUST, Wuhan

Wuhan Union Hospital of China, Wuhan

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hosiptal), Xi'an

The First Affiliated Hospital of Xiamen University, Xiamen

Henan Cancer Hospital, Zhengzhou

Henan Provincial People's Hospital, Zhengzhou

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hutchmed

INDUSTRY

NCT05522231 - Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2) | Biotech Hunter | Biotech Hunter