RecruitingPhase 2Phase 3NCT06361888

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer

Sponsor

Hutchmed

Enrollment

502 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic Cancer

Summary

To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase II/III trial is testing a four-drug combination — surufatinib (a targeted anti-tumor drug), camrelizumab (immunotherapy), nab-paclitaxel (chemotherapy), and gemcitabine (chemotherapy) — as a first-line treatment for metastatic pancreatic cancer, which is one of the hardest cancers to treat. **You may be eligible if...** - You are 18–75 years old - You have pancreatic cancer confirmed by biopsy and it has spread to other organs (Stage IV / metastatic) - You have not yet received any treatment for your metastatic pancreatic cancer - You have at least one measurable lesion - You are in good general health (ECOG 0–1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have received anti-tumor therapy within the past 2 weeks - You have another active cancer in the past 5 years - You have had major surgery within the last 60 days - You have active autoimmune disease or are on immunosuppressive medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSurufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Camrelizumab: 200mg, IV drip, Q3W, D1 3. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 4. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

DRUGNab-paclitaxel Plus Gemcitabine

Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

DRUGSurufatinib with Nab-paclitaxel, and Gemcitabine

Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

Locations(52)

Anhui Provincial Hospital

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chongqing General Hospital

Chongqing, Chongqing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Guangdong Provincial People's Hospital

Guandong, Guangzhou, China

Hainan General Hospital

Haikou, Hainan, China

First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Anyang Cancer Hospital

Anyang, Henan, China

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

XiangYa Hospital CentralSouth University

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Nantong Cancer Hospital

Nantong, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangyin People's Hospital

Wuxi, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Affiliated Hospital Of Jining Medical University

Jining, Shandong, China

Linyi People's Hospital

Linyi, Shandong, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospitial

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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