NCT06361888Toboroz2/3. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 17.
Rövid összefoglaló (regiszter, angolul)
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
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2/3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 502 (tervezett)
- Első benyújtás
- 2024. márc. 26.
- Kezdés
- 2024. máj. 8.
- Elsődleges befejezés
- 2028. máj. 31.
- Fő szponzor
- Hutchmed
- Betegségek
- Hasnyálmirigyrák
- NCT-szám
- NCT06361888
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
- Tervezett résztvevők: 502
- 2024. máj. 8. és az elsődleges befejezés (2028. máj. 31.) között
- 51 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose;
- Received major surgical surgery within 4 weeks before the first dose;
- Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
- Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
- Use of immunosuppressive drugs within 4 weeks before first dose;
Más betegség
- Presence of other malignancies in the past 5 years;
- Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
- Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
- Patients who currently have hypertension that cannot be controlled by medication;
Kiket keres a vizsgálat
- Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
- Age range is 18-75 years old (inclusive);
- Pancreatic cancer confirmed by histology or cytology;
- Stage IV metastasis Pancreatic cancer patients;
- Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;
- According to RECIST 1.1, there is at least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
- Expected survival time ≥ 12 weeks;
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (51)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Anyang Cancer Hospital | Anyang | Kína | Toboroz |
| Peking Union Medical College Hospital | Beijing | Kína | Toboroz |
| Peking University Third Hospital | Beijing | Kína | Toboroz |
| Beijing Cancer Hospital | Beijing | Kína | Toboroz |
| Jilin Cancer Hospital | Changchun | Kína | Toboroz |
| Hunan Cancer Hospital | Changsha | Kína | Toboroz |
| XiangYa Hospital CentralSouth University | Changsha | Kína | Toboroz |
| Sichuan Cancer Hospital | Chengdu | Kína | Toboroz |
| West China Hospital of Sichuan University | Chengdu | Kína | Toboroz |
| Chongqing General Hospital | Chongqing | Kína | Toboroz |
| Chongqing University Cancer Hospital | Chongqing | Kína | Toboroz |
| Fujian Cancer Hospital | Fuzhou | Kína | Toboroz |
| Guangdong Provincial People's Hospital | Guandong | Kína | Toboroz |
| Hainan General Hospital | Haikou | Kína | Toboroz |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Kína | Toboroz |
| Zhejiang Provincial People's Hospital | Hangzhou | Kína | Toboroz |
| Zhejiang Cancer Hospital | Hangzhou | Kína | Toboroz |
| Harbin Medical University Cancer Hospital | Harbin | Kína | Toboroz |
| Anhui Provincial Hospital | Hefei | Kína | Toboroz |
| Shandong Cancer Hospital | Jinan | Kína | Toboroz |
| Affiliated Hospital of Jining Medical University | Jining | Kína | Toboroz |
| Yunnan Cancer Hospital | Kunming | Kína | Toboroz |
| Linyi People's Hospital | Linyi | Kína | Toboroz |
| Jiangxi Cancer Hospital | Nanchang | Kína | Toboroz |
| The First Affiliated Hospital of NanChang University | Nanchang | Kína | Toboroz |
| Nanjing Drum Tower hospital | Nanjing | Kína | Toboroz |
| Nanjing Tianyinshan Hospital | Nanjing | Kína | Toboroz |
| Jiangsu Cancer Hospital | Nanjing | Kína | Toboroz |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Kína | Toboroz |
| Nantong Cancer Hospital | Nantong | Kína | Toboroz |
| First Hospital of Qinhuangdao | Qinhuangdao | Kína | Toboroz |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Kína | Toboroz |
| Zhongshan Hospital,Fudan University | Shanghai | Kína | Toboroz |
| Huashan Hospital, Fudan University | Shanghai | Kína | Toboroz |
| The First Hospital of China Medical University | Shenyang | Kína | Toboroz |
| Liaoning Cancer Hospital | Shenyang | Kína | Toboroz |
| Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center | Shenzhen | Kína | Toboroz |
| The First Affiliated Hospital of Soochow University | Suzhou | Kína | Toboroz |
| Shanxi Provincial Cancer Hospitial | Taiyuan | Kína | Toboroz |
| Tianjin Cancer Hospital | Tianjin | Kína | Toboroz |
| Tianjin Cancer Hospital Airport Hospital | Tianjin | Kína | Toboroz |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Kína | Toboroz |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Kína | Toboroz |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Kína | Toboroz |
| Hubei Cancer Hospital | Wuhan | Kína | Toboroz |
| Jiangyin People's Hospital | Wuxi | Kína | Toboroz |
| The First Affiliated hospital of Xiamen University | Xiamen | Kína | Toboroz |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Kína | Toboroz |
| The First Affiliated Hospital of Henan Medical University | Xinxiang | Kína | Toboroz |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Kína | Toboroz |
| Henan Cancer Hospital | Zhengzhou | Kína | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.